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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000319-26 | EudraCT Number |
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To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV, non-squamous non-small cell lung cancer (NSCLC) harboring a confirmed anaplastic lymphoma kinase (ALK) rearrangement, using the Ventana immunohistochemistry (IHC) test.
This was an open-label, randomized, global, Phase III study that compared the efficacy and safety of ceritinib to standard first-line chemotherapy in patients with advanced (NSCLC) harboring ALK rearrangement. The confirmation of ALK rearrangement was done using the ICH test by a Novartis designated central laboratory. Prior to the study, patients had not received any previous systemic, anti-cancer therapy, including ALK inhibitors, for newly diagnosed advanced non-squamous NSCLC.
The patients were randomized in a 1:1 ratio to either receive ceritinib (750 mg once daily, fasted) or chemotherapy. The chemotherapy regimen consisted of a platinum-based doublet with pemetrexed followed by pemetrexed maintenance in patients without progressive disease after 4 cycles.
Treatment was continued until the blinded independent review committee (BIRC) confirmed disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), occurrence of unacceptable toxicity, or meeting other discontinuation criteria. Patients in either arm were permitted to continue the assigned study treatment beyond BIRC-confirmed disease progression in case of continued clinical benefit, as determined by the Investigator.
All patients who discontinued treatment during the treatment phase for reasons other than death, lost to follow-up, pregnancy or disease progression entered the post-treatment follow-up period until disease progression, withdrawal of consent or death.
In the chemotherapy arm, patients were allowed to switch and receive ceritinib after BIRC-confirmed disease progression (extension-treatment period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceritinib | Experimental | Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state. |
|
| Chemotherapy | Active Comparator | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceritinib | Drug | Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) | PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. | From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method. | From date of randomization to date of death due to any cause, up to approximately 120 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | C1050AAK | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28126333 | Derived | Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24. | |
| 27130468 |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Participants had to satisfy all the inclusion criteria none of the exclusion criteria prior to randomization.
Patients were enrolled in 134 centers across 27 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ceritinib | Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state |
| FG001 | Chemotherapy | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Pemetrexed | Drug | Pemetrexed was administered at a dose of 500 mg/m^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle |
|
| Cisplatin | Drug | Cisplatin was administered by iv infusion at a dose of 75 mg/m^2 every 21 days for up to 4 cycles. |
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| Carboplatin | Drug | Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles |
|
| Overall Response Rate (ORR) by BIRC Assessment | ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 34 months |
| Overall Response Rate (ORR) by Investigator Assessment | ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by investigator assessment per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 120 months |
| Duration of Response (DOR) by BIRC Assessment | DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method. | From first documented response to first documented disease progression or death, assessed up to approximately 34 months |
| Duration of Response (DOR) by Investigator Assessment | DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by investigator assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method. | From first documented response to first documented disease progression or death, assessed up to approximately 120 months |
| Disease Control Rate (DCR) by BIRC Assessment | DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by BIRC assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Up to approximately 34 months |
| Disease Control Rate (DCR) by Investigator Assessment | DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by investigator assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Up to approximately 120 months |
| Time to Response (TTR) by BIRC Assessment | TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by BIRC assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event. | From randomization to date of first documented response, up to approximately 34 months |
| Time to Response (TTR) by Investigator Assessment | TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by investigator assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event | From randomization to date of first documented response, up to approximately 120 months |
| PFS by Investigator Assessment | PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by investigator assessment per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the KM method. | From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months |
| Overall Intracranial Response Rate (OIRR) | OIRR is defined as the ORR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 34 months |
| Intracranial Disease Control Rate (IDCR) | IDCR is defined as the DCR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated as the percentage of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | Up to approximately 34 months |
| Duration of Intracranial Response (DOIR) | DOIR is defined as the DOR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | From first documented response to first documented disease progression in the brain or death, assessed up to approximately 34 months |
| Time to Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire | The EORTC QLQ-LC13 complemented the QLQ-C30 and measured disease symptoms and treatment-related adverse effects. The lung cancer module incorporated one multi-item scale to assess dyspnea and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. Time to definitive symptom deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the symptoms (pain, cough or dyspnea) as per EORTC QLQ-LC13 (with no later change below this threshold i.e., <10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS) | The LCSS patient scale used a 24-hour recall period and contained nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The LCSS used a 100mm visual analog scale (VAS) to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). Time to definitive deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the LCSS scores related to pain in the chest, cough, or dyspnea (with no later change below this threshold i.e., <10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Least Squares Mean Scores on the EORTC-QLQ C30 | The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Least Squares Mean Scores on the EORTC QLQ- LC13 | The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS) | The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome). Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden. Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Least Squares Mean Scores on the EQ-5D-5L Index | The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS) | The EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
| Cmax of LDK378 | The observed maximum plasma concentration following administration | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
| Tmax of LDK378 | The time to reach peak or maximum concentration (Tmax) was assessed. Actual recorded sampling times were considered for the calculations | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
| Tlast of LDK378 | The time to last quantifiable concentration. Actual recorded sampling times were considered for the calculations | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
| AUC0-24 of LDK378 | The area under the plasma concentration-time curve calculated from time zero to 24 hours | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
| CABA |
| Buenos Aires |
| C1180AAX |
| Argentina |
| Novartis Investigative Site | La Rioja | 5300 | Argentina |
| Novartis Investigative Site | Woolloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Heidelberg | Victoria | 3084 | Australia |
| Novartis Investigative Site | Auckland | 92024 | Australia |
| Novartis Investigative Site | Salzburg | 5020 | Austria |
| Novartis Investigative Site | Vienna | 1210 | Austria |
| Novartis Investigative Site | Fortaleza | Ceará | 60336-045 | Brazil |
| Novartis Investigative Site | Salvador | Estado de Bahia | 40170-110 | Brazil |
| Novartis Investigative Site | Recife | Pernambuco | 50070-550 | Brazil |
| Novartis Investigative Site | Rio de Janiero | Rio de Janeiro | 20231-050 | Brazil |
| Novartis Investigative Site | Natal | Rio Grande do Norte | 59075 740 | Brazil |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Novartis Investigative Site | Itajaí | Santa Catarina | 88301-229 | Brazil |
| Novartis Investigative Site | Barretos | São Paulo | 14784 400 | Brazil |
| Novartis Investigative Site | São José do Rio Preto | São Paulo | 15090 000 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01246-000 | Brazil |
| Novartis Investigative Site | Guangzhou | Guangdong | 510080 | China |
| Novartis Investigative Site | Changchun | Jilin | 130012 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Shanghai | Shanghai Municipality | 200433 | China |
| Novartis Investigative Site | Xi’an | Shanxi | 710038 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310003 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310022 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Beijing | 101149 | China |
| Novartis Investigative Site | Chongqing | 400037 | China |
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| Novartis Investigative Site | Guang Dong Province | 510120 | China |
| Novartis Investigative Site | Tianjin | 300052 | China |
| Novartis Investigative Site | Bogota | Cundinamarca | 110111 | Colombia |
| Novartis Investigative Site | Montería | 230004 | Colombia |
| Novartis Investigative Site | Herlev | DK-2730 | Denmark |
| Novartis Investigative Site | Odense C | DK 5000 | Denmark |
| Novartis Investigative Site | Limoges | Haute Vienne | 87000 | France |
| Novartis Investigative Site | Toulon | Val De Marne | 83800 | France |
| Novartis Investigative Site | Caen | 14033 | France |
| Novartis Investigative Site | Grenoble | 38043 | France |
| Novartis Investigative Site | Lille | 59037 | France |
| Novartis Investigative Site | Paris | 75475 | France |
| Novartis Investigative Site | Pierre-Bénite | 69495 | France |
| Novartis Investigative Site | Rennes | 35043 | France |
| Novartis Investigative Site | Strasbourg | 67091 | France |
| Novartis Investigative Site | Villejuif | 94800 | France |
| Novartis Investigative Site | Cologne | 50937 | Germany |
| Novartis Investigative Site | Coswig | 01640 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Großhansdorf | 22947 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Oldenburg | 26121 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Wiesbaden | D-65199 | Germany |
| Novartis Investigative Site | Athens | GR | 115 27 | Greece |
| Novartis Investigative Site | Heraklion Crete | 71110 | Greece |
| Novartis Investigative Site | Zalaegerszeg | Zala County | 8900 | Hungary |
| Novartis Investigative Site | Budapest | 1121 | Hungary |
| Novartis Investigative Site | Nyíregyháza | 4400 | Hungary |
| Novartis Investigative Site | Veszprém | 8200 | Hungary |
| Novartis Investigative Site | Hyderabad | Andhra Pradesh | 500 034 | India |
| Novartis Investigative Site | Bangalore | Karnataka | 560 095 | India |
| Novartis Investigative Site | Kochi | Kerala | 682 041 | India |
| Novartis Investigative Site | Nashik | Maharashtra | 422 004 | India |
| Novartis Investigative Site | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Novartis Investigative Site | Jaipur | Rajasthan | 302017 | India |
| Novartis Investigative Site | Madurai | Tamil Nadu | 625107 | India |
| Novartis Investigative Site | Vellore | Tamil Nadu | 632 004 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700160 | India |
| Novartis Investigative Site | Delhi | 110 085 | India |
| Novartis Investigative Site | Mumbai | 400 012 | India |
| Novartis Investigative Site | Dublin | DO4 | Ireland |
| Novartis Investigative Site | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Bergamo | BG | 24125 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Milan | MI | 20141 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Perugia | PG | 06129 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Aviano | PN | 33081 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Reggio Emilia | RE | 42123 | Italy |
| Novartis Investigative Site | Roma | RM | 00152 | Italy |
| Novartis Investigative Site | Roma | RM | 00189 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 464 8681 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277 8577 | Japan |
| Novartis Investigative Site | Akashi | Hyōgo | 673-8558 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-1191 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 541-8567 | Japan |
| Novartis Investigative Site | Koto Ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Niigata | 951 8520 | Japan |
| Novartis Investigative Site | El Achrafiyé | 166830 | Lebanon |
| Novartis Investigative Site | Saida | 652 | Lebanon |
| Novartis Investigative Site | Guadalajara | Jalisco | 44280 | Mexico |
| Novartis Investigative Site | Leiden | South Holland | 2333 ZA | Netherlands |
| Novartis Investigative Site | Amersfroort | 3818 ES | Netherlands |
| Novartis Investigative Site | Enschede | 7512 KZ | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Groningen | 9728 NZ | Netherlands |
| Novartis Investigative Site | Maastricht | 6229 HX | Netherlands |
| Novartis Investigative Site | Zoetermeer | NL-2722 EP | Netherlands |
| Novartis Investigative Site | Oslo | 0310 | Norway |
| Novartis Investigative Site | Szczecin | 70-891 | Poland |
| Novartis Investigative Site | Warsaw | 02 781 | Poland |
| Novartis Investigative Site | Moscow | 115478 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Singapore | 168583 | Singapore |
| Novartis Investigative Site | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Gyeonggi-do | Korea | 10408 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41014 | Spain |
| Novartis Investigative Site | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Lleida | Catalonia | 25198 | Spain |
| Novartis Investigative Site | Mataró | Catalonia | 08301 | Spain |
| Novartis Investigative Site | Reus | Catalonia | 43201 | Spain |
| Novartis Investigative Site | Badajoz | Extremadura | 06080 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Lugo | Galicia | 27003 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Novartis Investigative Site | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46014 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28033 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Madrid | 28050 | Spain |
| Novartis Investigative Site | Linköping | SE 581 85 | Sweden |
| Novartis Investigative Site | Lund | 221 85 | Sweden |
| Novartis Investigative Site | Stockholm | 171 76 | Sweden |
| Novartis Investigative Site | Uppsala | 751 85 | Sweden |
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan |
| Novartis Investigative Site | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Taichung | 407219 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| Novartis Investigative Site | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Khon Kaen | THA | 40002 | Thailand |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Ankara | 06230 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 35100 | Turkey (Türkiye) |
| Novartis Investigative Site | Exeter | Devon | EX2 5DW | United Kingdom |
| Novartis Investigative Site | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | London | NW1 2BU | United Kingdom |
| Novartis Investigative Site | Manchester | M20 2BX | United Kingdom |
| Novartis Investigative Site | Nottingham | NG5 1PB | United Kingdom |
| Derived |
| Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| Extension-treatment Phase |
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The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceritinib | Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state |
| BG001 | Chemotherapy | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) | PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by BIRC per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 34 months |
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| Secondary | Overall Survival (OS) | OS defined as time from date of randomization to date of death due to any cause. If the patient was alive at the date of the analysis cut-off or lost to follow-up, then OS was censored at the last contact date prior to data cut-off date. The distribution of OS was estimated using the KM method. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization | Posted | Median | 95% Confidence Interval | Months | From date of randomization to date of death due to any cause, up to approximately 120 months |
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| Secondary | Overall Response Rate (ORR) by BIRC Assessment | ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by BIRC per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 34 months |
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| Secondary | Overall Response Rate (ORR) by Investigator Assessment | ORR is defined as the percentage of patients with a best overall response defined as complete response (CR) or or partial response (PR) measured by investigator assessment per RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 120 months |
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| Secondary | Duration of Response (DOR) by BIRC Assessment | DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by BIRC assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment. | Posted | Median | 95% Confidence Interval | Months | From first documented response to first documented disease progression or death, assessed up to approximately 34 months |
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| Secondary | Duration of Response (DOR) by Investigator Assessment | DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression (measured by investigator assessment per RECIST 1.1) or death due to any cause. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a patient had not had an event, DOR was censored at the date of last adequate tumor assessment. Patients who had never achieved a best overall response of CR or PR were excluded from the analysis. The distribution function of DOR was estimated using the KM method. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by investigator assessment. | Posted | Median | 95% Confidence Interval | Months | From first documented response to first documented disease progression or death, assessed up to approximately 120 months |
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| Secondary | Disease Control Rate (DCR) by BIRC Assessment | DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by BIRC assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 34 months |
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| Secondary | Disease Control Rate (DCR) by Investigator Assessment | DCR is defined as the percentage of patients with best overall response of CR, PR, or stable disease (SD) measured by investigator assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 120 months |
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| Secondary | Time to Response (TTR) by BIRC Assessment | TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by BIRC assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by BIRC assessment. | Posted | Median | Full Range | Weeks | From randomization to date of first documented response, up to approximately 34 months |
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| Secondary | Time to Response (TTR) by Investigator Assessment | TTR is defined as the time from date of randomization to date of first documented response (CR or PR) measured by investigator assessment per RECIST 1.1. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Patients who had not achieved a confirmed CR or PR were censored at the last adequate tumor assessment date when they had not had a PFS event or at maximum follow-up when they had had a PFS event | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with confirmed CR or PR by investigator assessment. | Posted | Median | Full Range | Weeks | From randomization to date of first documented response, up to approximately 120 months |
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| Secondary | PFS by Investigator Assessment | PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression (as assessed by investigator assessment per RECIST 1.1) or death due to any cause. A patient who had not progressed or died at the date of the analysis cut-off or had received another anticancer therapy had their PFS censored at the time of the last adequate tumor evaluation before the earlier of the cut-off date or the anticancer therapy date. The distribution of PFS was estimated using the KM method. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of first radiologically documented disease progression or death due to any cause, up to approximately 120 months |
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| Secondary | Overall Intracranial Response Rate (OIRR) | OIRR is defined as the ORR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated as the percentage of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1 as assessed by BIRC neuroradiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable brain disease and who had a baseline and at least one post-baseline scan | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 34 months |
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| Secondary | Intracranial Disease Control Rate (IDCR) | IDCR is defined as the DCR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated as the percentage of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable brain disease and who had a baseline and at least one post-baseline scan | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 34 months |
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| Secondary | Duration of Intracranial Response (DOIR) | DOIR is defined as the DOR based on lesions in brain (target, non-target lesions and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1 as assessed by BIRC neuro-radiologist. CR: Disappearance of all lesions with lymph nodes measuring < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Patients with measurable brain disease and who had a baseline and at least one post-baseline scan, and a confirmed intracranial CR or PR | Posted | Median | 95% Confidence Interval | Months | From first documented response to first documented disease progression in the brain or death, assessed up to approximately 34 months |
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| Secondary | Time to Definitive 10 Point Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire | The EORTC QLQ-LC13 complemented the QLQ-C30 and measured disease symptoms and treatment-related adverse effects. The lung cancer module incorporated one multi-item scale to assess dyspnea and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. Time to definitive symptom deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the symptoms (pain, cough or dyspnea) as per EORTC QLQ-LC13 (with no later change below this threshold i.e., <10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | Months | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Time to Definitive Deterioration in the Composite Endpoint of Pain, Cough or Dyspnea in the Lung Cancer Symptom Scale (LCSS) | The LCSS patient scale used a 24-hour recall period and contained nine items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain), and three summary items related to total symptom distress, normal activity status, and overall quality of life. The LCSS used a 100mm visual analog scale (VAS) to measure the intensity of patient responses, with zero corresponding to the lowest rating (best status) and 100 representing the highest rating (worst status). Time to definitive deterioration for the composite endpoint was defined as the time from the date of randomization to the earliest date when the patient's score showed a 10 point or higher increase from baseline in any of the LCSS scores related to pain in the chest, cough, or dyspnea (with no later change below this threshold i.e., <10 points was observed or if this increase was observed at the last assessment for the patient) or death due to any cause. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. | Posted | Median | 95% Confidence Interval | Months | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Least Squares Mean Scores on the EORTC-QLQ C30 | The EORTC QLQ-C30 contained 30 items and was of both multi-item scales and single-item measures, including 5 functional scales (physical, role, emotional, cognitive, and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status (GHS)/quality of life (QoL) scale. Items were assessed on a 4- or 7-level Likert scale, ranging from 1="very poor" to 7= "excellent" for GHS items and 1= "not at all" to 4= "very much" for all other items. The scores of the scales were averaged from the scores of the component items, transformed, and analyzed on a 0 - 100 scale. A high score represented a higher response level. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the scales/single items | Posted | Least Squares Mean | Standard Error | Score on a scale | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Least Squares Mean Scores on the EORTC QLQ- LC13 | The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores | Posted | Least Squares Mean | Standard Error | Score on a scale | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Least Squares Mean Scores on the Lung Cancer Symptom Scale (LCSS) | The LCSS consisted of 9 individual items; 6 measured lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis, and pain); the remaining 3 items measured general lung cancer symptom distress, interference with daily activities and overall QoL. Each item was scored on a 100-millimeter Visual Analogue Scale (VAS), with scores ranging from 0 to 100 (0 = best outcome). Total score was calculated as the average of the aggregate score of all 9 items. Scores ranged from 0 to 100, with higher total scores indicating a greater overall impact of symptoms on the patient's QoL. The Symptom Burden Index (SBI) was calculated as the average of the six symptom items. It also ranged from 0 to 100, with higher scores indicating greater symptom burden. Scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores | Posted | Least Squares Mean | Standard Error | Score on a Scale | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Least Squares Mean Scores on the EQ-5D-5L Index | The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each of these dimensions, the participant self-assigned a score: from 1 (no problems) to 5 (extreme problems). The 5 digit health states obtained for each dimension was converted into a single mean index value based on the EQ-5D crosswalk value set for the UK using the time trade-off method. This index ranges from -0.594 (worst health) to 1.0 (best health). The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Least Squares Mean Scores on the EQ-5D-5L Visual Analogue Score (VAS) | The EQ-5D-5L questionnaire is a standardized measure of health status. The EQ-5D-5L descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state. A positive change from baseline indicates improvement. The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months |
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| Secondary | Cmax of LDK378 | The observed maximum plasma concentration following administration | The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable pharmacokinetic (PK) blood sample. Only the subset of participants with extensive PK collection were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram (ng) / mililiter (ml) | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
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| Secondary | Tmax of LDK378 | The time to reach peak or maximum concentration (Tmax) was assessed. Actual recorded sampling times were considered for the calculations | The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed. | Posted | Median | Full Range | hours | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
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| Secondary | Tlast of LDK378 | The time to last quantifiable concentration. Actual recorded sampling times were considered for the calculations | The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed | Posted | Median | Full Range | Hours | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
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| Secondary | AUC0-24 of LDK378 | The area under the plasma concentration-time curve calculated from time zero to 24 hours | The Pharmacokinetic Analysis Set (PAS) consisted of all patients who received at least one (full or partial) dose of LDK378 and provided at least one evaluable PK blood sample. Only the subset of participants with extensive PK collection were analyzed | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | Cycle 1 Day 1 and Cycle 2 Day 1 at pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose. Cycle=21 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | All Collected Deaths | Pre-treatment: From randomization to start of treatment. On-Treatment: From start of treatment to 30 days post-treatment or start of crossover treatment. Extension-treatment: From start of crossover treatment to 30 days post-crossover treatment. Post-treatment: From 31 days after last dose of treatment to the end of study. | The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. For the Chemotherapy/Ceritinib group, the analysis included patients randomized to the chemotherapy arm who crossed over and received at least one dose of ceritinib | Posted | Count of Participants | Participants | No | Pre-treatment: up to 28 days; On-Treatment: up to approx. 120 months; Extension-treatment: up to approx. 108 months; Post-treatment: up to approx. 120 months |
|
All-cause mortality: from randomization up to approx. 120 months, including post-treatment survival follow-up period. Serious and Other Adverse Events (AEs): from first dose of study treatment until 30 days after last dose (or start of crossover treatment), up to approx. 120 months. For participants who crossed over, AEs were also collected from start of crossover treatment to 30 days post-crossover treatment (extension-treatment period), up to approx. 108 months.
All-cause mortality: reported for all randomized participants regardless of whether the assigned study treatment was received. Deaths in post-treatment survival follow-up period (more than 30 days after last dose) are reported separately and are not considered AEs.
Serious and Other AEs: reported for all randomized participants who received at least one dose of study treatment
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceritinib | All-cause mortality from randomization until 30 days after last dose. Adverse Events from first dose until 30 days after last dose. | 15 | 189 | 93 | 189 | 186 | 189 |
| EG001 | Chemotherapy | All-cause mortality from randomization until 30 days after last dose or start of crossover treatment. Adverse Events from first dose until 30 days after last dose or start of crossover treatment. | 10 | 187 | 64 | 175 | 166 | 175 |
| EG002 | Chemotherapy to Ceritinib (Extension-treatment) | All-cause mortality and Adverse Events from start of crossover treatment to 30 days post-crossover treatment | 15 | 100 | 47 | 100 | 99 | 100 |
| EG003 | Ceritinib (Post-treatment Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period | 98 | 149 | 0 | 0 | 0 | 0 |
| EG004 | Chemotherapy (Post-treatment Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose). No AEs were collected during this period | 38 | 60 | 0 | 0 | 0 | 0 |
| EG005 | Chemotherapy to Ceritinib (Post-treatment Follow-up) | Deaths collected in the post- treatment survival follow-up period (starting from day 31 after last dose of crossover treatment). No AEs were collected during this period | 56 | 83 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute hepatitis B | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Brain abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Eye abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Meningitis bacterial | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pyomyositis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Salmonella sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.1) | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Gastrointestinal somatic symptom disorder | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Renal tubular disorder | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@Novartis.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C586847 | ceritinib |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Physician Decision |
|
| Progressive disease |
|
| Study terminated by sponsor |
|
| Subject/guardian decision |
|
| Male |
|
| Black |
|
| Caucasian |
|
| Native American |
|
| Other |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Chemotherapy |
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
|
|
| OG001 |
| Chemotherapy |
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
|
|
| OG001 | Chemotherapy | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
|
|
| OG001 |
| Chemotherapy |
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
|
|
| OG001 | Chemotherapy | Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance) |
|
|
|
|
Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
|
|
|
|
|
|
|
|