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This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase) Positive East Asian Non-Small Cell Lung Cancer Patients. The objective of the study is to demonstrate that Crizotinib is superior to first-line chemotherapy pemetrexed/cisplatin or pemetrexed/carboplatin in prolonging Progression Free Survival (PFS) in East Asian patients with advanced Non-Squamous NSCLC whose tumors harbor a translocation or inversion event involving the ALK (Anaplastic Lymphoma Kinase) gene locus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizotinib | Experimental | Crizotinib |
|
| Chemotherapy | Active Comparator | Chemotherapy [Option at Investigator's Choice] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | 250 mg two times daily [BID], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Based on IRR by Treatment Arm | PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University, Department of Medical Oncology | Hefei | Anhui | 230002 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29966800 | Derived | Wu YL, Lu S, Lu Y, Zhou J, Shi YK, Sriuranpong V, Ho JCM, Ong CK, Tsai CM, Chung CH, Wilner KD, Tang Y, Masters ET, Selaru P, Mok TS. Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus Chemotherapy in East Asian Patients with ALK-Positive Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Oct;13(10):1539-1548. doi: 10.1016/j.jtho.2018.06.012. Epub 2018 Aug 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants with histologically or cytologically proven diagnosis of locally advanced, recurrent, or metastatic non squamous non small cell lung cancer and tumors with measurable disease were enrolled. Participants were to be positive for translocation or inversion events involving the ALK gene locus as determined by an ALK break-apart FISH test.
This phase 3, randomized, open label, multicenter study conducted in 35 centers in 5 countries. A total of 207 actual participants were randomized, 104 in the crizotinib arm and 103 in the chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crizotinib | Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pemetrexed/Cisplatin | Drug | Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles. |
|
| Pemetrexed/Carboplatin | Drug | Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles. |
|
| Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months) |
| Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - date of randomization +1)/30.44. For participants who were lost to follow-up or withdrew consent, the OS was censored on the last date that participants were known to be alive. | From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months). |
| Percentage of Participants With Disease Control at 12 Weeks Based on IRR | Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | From randomization to Week 12 |
| Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log [-log(1-year survival probability)] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly. | From randomization to 1 year and from randomization to 18 months |
| Duration of Response (DR) Based on IRR | DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death - first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response. | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
| Time to Tumor Response (TTR) Based on IRR | TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response. | Randomization to first documentation of objective tumor response (up to 33 months). |
| Time to Progression (TTP) Based on IRR | TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44. | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
| Intracranial Time to Progression (IC-TTP) Based on IRR | IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
| Extracranial Time to Progression (EC-TTP) Based on IRR | EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
| Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough Assessed Using Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) | The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Coughing, Dyspnoea and Pain in chest each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. TTD in pain in chest, dyspnea, or cough from the QLQ-LC13 was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
| Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life. | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
| Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dyspnea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
| Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
| Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)-Visual Analog Scale (VAS) | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
| Change From Baseline in General Health Status as Assessed by EQ-5D-Index | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months) |
| Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK) | VSAQ-ALK is a self-report measure that was developed to assess the problems of visual disturbances and symptoms may include the appearance of overlapping shadows and after images; shimmering, flashing or trailing lights; strings, streamers, or floaters; as well as hazy or blurry vision. The participants answered "Yes" to the first question (Q1) of VSAQ-ALK "Have you experienced any visual disturbances?" were considered to have experienced visual disturbance and were instructed to complete the rest of the questionnaire. The percentage of participants who responded to Q1 of VSAQ-ALK as "Yes" and as "No" during each study cycle was calculated as (n/N*)*100 where N* was the number of participants who had completed Q1. | Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to Cycle 86) |
| Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable | Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results. | During the screening (less than or equal to 28 days prior to dosing) |
| Percentage of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities) | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) |
| Percentage of Participants With Treatment-Emergent AEs (Treatment Related) | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) |
| Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Dept. of Respiration. Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| Beijing Chest Hospital, Capital Medical University | Beijing | Beijing Municipality | 101149 | China |
| Oncology Department, the Second Affiliated Hospital of Third Military Medical University,PLA | Chongqing | Chongqing Municipality | 400037 | China |
| Oncology Department, XinQiao Hospital of Third Military Medical University, | Chongqing | Chongqing Municipality | 400037 | China |
| Fujian Province Oncology Hospital | Fuzhou | Fujian | 350014 | China |
| SUN Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Guangdong General Hospital, Oncology Center | Guangzhou | Guangdong | 510080 | China |
| The First Affiliated Hospital of Guangzhou Medical College/Thoracic Surgery | Guangzhou | Guangdong | 510120 | China |
| Department 2 of Chemotherapy, Tumour Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | 530021 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology/Cancer Center | Wuhan | Hubei | 430030 | China |
| Hunan Provincial Tumor Hospital/Division of Oncology | Changsha | Hunan | 410013 | China |
| Nanjing General Hospital of Nanjing Military Command, Department of Respiratory medicine | Nanjing | Jiangsu | 210002 | China |
| Department of Oncology, Jilin Provincial Cancer Hospital | Changchun | Jilin | 130012 | China |
| The first hospital of China Medical University/Oncology Department | Shenyang | Liaoning | 110001 | China |
| Oncology Department, West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Sichuan Province Cancer Hospital/Department of Pulmonary Tumor | Chengdu | Sichuan | 610041 | China |
| Department of Respiratory, The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University, Center for Oncology | Hangzhou | Zhejiang | 310016 | China |
| 307 Hospital of PLA/Department of Lung Cancer | Beijing | 100071 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The Military General Hospital of Beijing PLA | Beijing | 100700 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Beijing Chest Hospital, Capital Medical University | Beijing | 101149 | China |
| Respiration department,the First Affiliated Hospital of Third Military Medical University, PLA | Chongqing | 400038 | China |
| Shanghai Chest Hospital/Lung cancer clinical center | Shanghai | 200030 | China |
| Shanghai Chest Hospital | Shanghai | 200030 | China |
| Zhongshan Hospital Fudan University / Respiratory Department | Shanghai | 200032 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | 300060 | China |
| Pamela Youde Nethersole Eastern Hospital | Chai Wan | 0 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 0 | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Department of Nuclear Medicine, Radiotherapy and Oncology, Hospital Universiti Sains Malaysia | Kubang Kerian, Kota Bahru | Kelantan | 16150 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10990 | Malaysia |
| Chi Mei Medical Center Liouying | Liou Ying Township | Tainan | 736 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| Chi Mei Medical Center Liuying | Tainan | 736 | Taiwan |
| Taipei Veterans General Hospital, Chest Department | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation, LinKou Branch | Taoyuan | 333 | Taiwan |
| Medical Oncology Unit, Department of Medicine, Faculty of Medicine, Chulalongkorn University | Pathumwan | Bangkok | 10330 | Thailand |
| Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, | Bangkok | 10700 | Thailand |
| FG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
| Treated |
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| COMPLETED | "Completed" refers to either those patients who switched to commercial supplies of crizotinib or those patients who were in survival follow up, when the Sponsor sent a written End of Study notification to the study sites. |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crizotinib | Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks. |
| BG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | 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) Based on IRR by Treatment Arm | PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months) |
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| Secondary | Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR | Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - date of randomization +1)/30.44. For participants who were lost to follow-up or withdrew consent, the OS was censored on the last date that participants were known to be alive. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Median | 95% Confidence Interval | Months | From randomization to death or last date known as alive for those who were lost to follow-up or withdrew consent (assessed up to 64 months). |
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| Secondary | Percentage of Participants With Disease Control at 12 Weeks Based on IRR | Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to Week 12 |
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| Secondary | Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months | Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log [-log(1-year survival probability)] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly. | The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Number | 95% Confidence Interval | Percentage of paricipants | From randomization to 1 year and from randomization to 18 months |
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| Secondary | Duration of Response (DR) Based on IRR | DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death - first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR. | Posted | Median | 95% Confidence Interval | Weeks | From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
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| Secondary | Time to Tumor Response (TTR) Based on IRR | TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR. | Posted | Median | Full Range | Weeks | Randomization to first documentation of objective tumor response (up to 33 months). |
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| Secondary | Time to Progression (TTP) Based on IRR | TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date - randomization date +1)/30.44. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
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| Secondary | Intracranial Time to Progression (IC-TTP) Based on IRR | IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
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| Secondary | Extracranial Time to Progression (EC-TTP) Based on IRR | EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions. | FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. | Posted | Median | 95% Confidence Interval | Months | Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, up to 33 months) |
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| Secondary | Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough Assessed Using Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) | The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Coughing, Dyspnoea and Pain in chest each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. TTD in pain in chest, dyspnea, or cough from the QLQ-LC13 was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment for pain in chest, dyspnea or cough. | Posted | Median | 95% Confidence Interval | Months | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
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| Secondary | Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
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| Secondary | Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30 | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dyspnea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
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| Secondary | Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) | The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
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| Secondary | Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)-Visual Analog Scale (VAS) | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months） |
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| Secondary | Change From Baseline in General Health Status as Assessed by EQ-5D-Index | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months) |
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| Secondary | Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK) | VSAQ-ALK is a self-report measure that was developed to assess the problems of visual disturbances and symptoms may include the appearance of overlapping shadows and after images; shimmering, flashing or trailing lights; strings, streamers, or floaters; as well as hazy or blurry vision. The participants answered "Yes" to the first question (Q1) of VSAQ-ALK "Have you experienced any visual disturbances?" were considered to have experienced visual disturbance and were instructed to complete the rest of the questionnaire. The percentage of participants who responded to Q1 of VSAQ-ALK as "Yes" and as "No" during each study cycle was calculated as (n/N*)*100 where N* was the number of participants who had completed Q1. | Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment. | Posted | Number | Percentage of participants | Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to Cycle 86) |
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| Secondary | Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable | Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results. | The MP evaluable population included 812 participants, of which there were 771 participants that had a test result (positive or negative) from both the FISH test and the IHC test. | Posted | Count of Participants | Participants | During the screening (less than or equal to 28 days prior to dosing) |
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| Secondary | Percentage of Participants With Treatment-Emergent Adverse Events (AEs; All Causalities) | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. | All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received. | Posted | Number | Percentage of participants | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) |
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| Secondary | Percentage of Participants With Treatment-Emergent AEs (Treatment Related) | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. | All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received. | Posted | Number | Percentage of participants | From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks) |
|
From the first dose of study medication up to 28 days after the last dose of study medication or up to the time that a participant died or received subsequent anticancer treatment (maximum duration between first and last dose: 324.4 weeks).
An event may be categorized as serious in 1 participant and as nonserious in another, or 1 participant may have experienced both serious and nonserious event. Participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the 1st cycle were analyzed for AEs.
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 | Crizotinib | Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit. The maximum duration of crizotinib treatment was 324.4 weeks. | 62 | 104 | 46 | 104 | 103 | 104 |
| EG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. | 61 | 101 | 13 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Syncope | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Non-systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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
| Male |
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| Superiority or Other (legacy) |
| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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Participants in the Molecular Profiling Evaluable population that had negative ALK FISH results. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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| OG001 | Chemotherapy | Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion. The maximum duration of chemotherapy treatment was 24.1 weeks. |
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