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The purpose of this study was to evaluate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162 in advanced NSCLC patients carrying specific molecular alterations.
There is a great unmet medical need in NSCLC patients with advanced or metastatic disease. Novel approaches using targeted therapeutic agents for these patient populations with molecular characterization could potentially identify subsets of advanced NSCLC patients who would benefit from targeted kinase inhibition. Study treatments, BYL719, INC280, LDK378 and MEK162, which target PIK3CA, c-MET, ALK/ROS1 and MEK respectively, have shown promising data in either preclinical or clinical lung cancer settings.
To enter the screening phase of the study, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample (preferred) or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor (EGFR) and the relevant pathways were excluded, except under the conditions described in Inclusion criteria.
The treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, death or the subject transferred to another Novartis study that could continue to provide the study drug.
All subjects were required to be followed up for 30 days for safety after receiving the last dose of study treatment. Subjects who discontinued study treatment for any reason other than disease progression were followed up for progression of disease. All subjects were required to be followed for survival. For subjects transferred to another Novartis study, an end of treatment visit (EOT) was required to be performed and the subject would not enter the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYL719 350 mg QD | Experimental | Patient's tumor must have molecular alteration of the PIK3CA gene. |
|
| INC280 400 mg BID tab/600 mg BID cap | Experimental | Patient's tumor must have molecular alteration of the c-MET gene. |
|
| LDK378 750 mg QD | Experimental | Patient's tumor must have ALK or ROS1 gene rearrangement. |
|
| MEK162 45 mg BID | Experimental | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYL719 | Drug | BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (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 Partial Response (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 231 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival (OS) | OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. | Up to 231 weeks |
| Number of Participants With Progression-free Survival (PFS) |
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Inclusion Criteria:
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 | Guangzhou | Guangdong | 51000 | China |
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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To enter the screening phase, the subjects' molecular alterations were determined using locally validated methodologies from a newly obtained tumor sample or the most recent archival tumor sample available. Based on the molecular alterations of the tumor, subjects were assigned to one of the treatment arms. Subjects with multiple molecular alterations in epidermal growth factor receptor and the relevant pathways were excluded, except under the conditions described in Inclusion criteria.
Participants were from China
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| ID | Title | Description |
|---|---|---|
| FG000 | BYL719 350 mg QD | Patient's tumor must have molecular alteration of the PIK3CA gene. |
| FG001 | INC280 400 mg BID Tab/600 mg BID Cap | Patient's tumor must have molecular alteration of the c-MET gene. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2019 | Oct 14, 2020 |
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|
| INC280 | Drug | INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed. |
|
| LDK378 | Drug | LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed. |
|
| MEK162 | Drug | MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed. |
|
PFS event is defined as the first documented progression or death due to any cause according to RECIST 1.1 criteria
| Up to 231 weeks |
| Disease Control Rate (DCR) | DCR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or Stable Disease (SD) according to RECIST 1.1 criteria (DCR: CR+PR+SD) Complete Response (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 Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD | Up to 231 weeks |
| Median Duration of Overall Response (DOR) | Duration of overall response (DOR) is defined as the time from the first documented CR or PR (confirmed by the subsequent assessment) to the date of the first documented progression or death due to underlying cancer. | Up to 231 weeks |
| Number of Participants With Adverse Events | Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4, was used. | up to 235 weeks |
| Pharmacokinetics Profile, AUCtau and AUClast | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
| Pharmacokinetics Profile, Cmax | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). Cmax is the maximum (peak) observed plasma concentration (mass x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
| Pharmacokinetics Profile, Tmax | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). Tmax is the time to reach maximum (peak) plasma concentration (time) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
| FG002 | LDK378 750 mg QD | Patient's tumor must have ALK or ROS1 gene rearrangement. |
| FG003 | MEK162 45 mg BID | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BYL719 350 mg QD | Patient's tumor must have molecular alteration of the PIK3CA gene. |
| BG001 | INC280 400 mg BID Tab/600 mg BID Cap | Patient's tumor must have molecular alteration of the c-MET gene. |
| BG002 | LDK378 750 mg QD | Patient's tumor must have ALK or ROS1 gene rearrangement. |
| BG003 | MEK162 45 mg BID | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
| BG004 | 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 | Inter-Quartile Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Overall response rate is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria (Overall Response (OR) = CR + PR). Complete Response (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 Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. | Full analysis set: all subjects who received at least one dose of the respective study treatment. | Posted | Count of Participants | Participants | Up to 231 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) | OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. | Full analysis set: all subjects who received at least one dose of the respective study treatment. | Posted | Median | 95% Confidence Interval | Months | Up to 231 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Progression-free Survival (PFS) | PFS event is defined as the first documented progression or death due to any cause according to RECIST 1.1 criteria | Full analysis set: all subjects who received at least one dose of the respective study treatment. | Posted | Count of Participants | Participants | Up to 231 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) or Stable Disease (SD) according to RECIST 1.1 criteria (DCR: CR+PR+SD) Complete Response (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 Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD | Full analysis set: all subjects who received at least one dose of the respective study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 231 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Duration of Overall Response (DOR) | Duration of overall response (DOR) is defined as the time from the first documented CR or PR (confirmed by the subsequent assessment) to the date of the first documented progression or death due to underlying cancer. | Full analysis set subjects with confirmed complete response (CR) or partial response (PR) | Posted | Median | 95% Confidence Interval | Months | Up to 231 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4, was used. | Safety Set: Includes all patients who received at least one dose of the respective study medication and had at least one valid postbaseline safety assessment. | Posted | Count of Participants | Participants | up to 235 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics Profile, AUCtau and AUClast | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). AUCtau is the AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) AUClast is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data. | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics Profile, Cmax | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). Cmax is the maximum (peak) observed plasma concentration (mass x volume-1) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics Profile, Tmax | PK parameters are estimated from each individual plasma concentration-time profile using non-compartmental analysis (Phoenix software version 6.2 and above). Tmax is the time to reach maximum (peak) plasma concentration (time) On Cycle 1 Day 1, PK parameters for only BYL719 350 mg QD arm were analyzed | PAS: Pharmacokinetic analysis set includes all subjects who have at least one blood sample providing evaluable PK data. | Posted | Median | Full Range | hours | Day 1 (pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 hours) and Day 15 (pre dose, 0.5, 1, 2, 4, 6, 8 hours post dose and only for BYL719 350 mg QD and LDK378 750 mg QD arms also at 24 hours post dose) |
|
Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days after receiving the last dose of study treatment, up to maximum duration of 235 weeks.
Any sign or symptom that occurs during the study treatment plus 30 days after receiving the last dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BYL719 350 mg QD | Patient's tumor must have molecular alteration of the PIK3CA gene. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG001 | INC280 400 mg BID Tab/600 mg BID Cap | Patient's tumor must have molecular alteration of the c-MET gene. | 4 | 16 | 12 | 16 | 16 | 16 |
| EG002 | LDK378 750 mg QD | Patient's tumor must have ALK or ROS1 gene rearrangement. | 1 | 26 | 11 | 26 | 26 | 26 |
| EG003 | MEK162 45 mg BID | Patient's tumor must have KRAS, NRAS or BRAF mutation. | 5 | 22 | 18 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rheumatic heart disease | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atrioventricular dissociation | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Wandering pacemaker | Cardiac disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Scleritis | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Faeces hard | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gastric dilatation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oesophageal oedema | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Erythrasma | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Albumin urine present | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatine increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase MB increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Enzyme level increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| PO2 decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Protein total decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Thrombin time prolonged | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA (22.1) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Alkalosis | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dreamy state | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysphoria | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tic | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA (22.1) | 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 the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 26, 2019 | Nov 20, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C585539 | Alpelisib |
| C000613976 | capmatinib |
| C586847 | ceritinib |
| C581313 | binimetinib |
Not provided
Not provided
Not provided
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG003 | MEK162 45 mg BID | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG003 | MEK162 45 mg BID | Patient's tumor must have KRAS, NRAS or BRAF mutation. |
|
|
Patient's tumor must have KRAS, NRAS or BRAF mutation. |
|
|
Patient's tumor must have KRAS, NRAS or BRAF mutation. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|