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400mg of capmatinib tablets, administered orally twice daily

Docetaxel 75 mg/m2 solution administered by intravenous infusion on Day 1 of every 21-day cycle

400mg of capmatinib tablets administered orally twice daily

Capmatinib

Docetaxel 75 mg/m2 by intravenous infusion every 21 days

Novartis Pharmaceuticals

The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.

Approximately 90 patients with advanced or metastatic lung cancer, with these specific mutations in the MET gene but without changes in their epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genes, will be enrolled in this study. Participants will be randomly assigned to get either capmatinib or docetaxel in a 2 to 1 ratio. The randomization will be stratified by prior lines of systemic therapy received for advanced/metastatic disease (one line vs. two lines).

During treatment, visits will be scheduled every 21 days.

For all participants, the respective treatment (either with capmatinib or docetaxel) may be continued beyond initial disease progression as per RECIST 1.1 (as assessed by the investigator and confirmed by BIRC) if, in the judgment of the investigator, there is evidence of clinical benefit, and the participant wishes to continue on the study treatment. After treatment discontinuation, all participants will be followed for safety evaluations during the safety follow-up period, and the participant's status will be collected every 12 weeks as part of the survival follow-up.

Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after BIRC-confirmed, RECIST 1.1-defined progressive disease and after meeting the eligibility criteria prior to crossover.

Participants randomized to docetaxel treatment will be eligible to crossover to receive capmatinib treatment after blinded independent review committee (BIRC)-confirmed, RECIST 1.1- defined disease progression.

Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METΔex14).

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

Progression free survival is defined as the time from the date of randomization to the date of the first documented progression assessed by BIRC according to RECIST 1.1, or death due to any cause

Percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR), assessed by BIRC according to RECIST 1.1.

Percentage of participants with confirmed BOR of CR or PR, assessed by local review according to RECIST 1.1.

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by BIRC according to RECIST 1.1.

Time from date of randomization to first documented response of either CR or PR, which must be subsequently confirmed, assessed by local review according to RECIST 1.1.

Time from the date of first documented response (CR or PR) to the first documented progression by BIRC per RECIST 1.1 or death due to any cause.

Time from the date of first documented response (CR or PR) to the first documented progression by local review per RECIST 1.1 or death due to any cause.

Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) assessed by BIRC according to RECIST 1.1

Percentage of participants with a BOR of confirmed CR, PR and SD assessed by local review according to RECIST 1.1

Time from the date of randomization to the date of the first documented progression assessed by local review according to RECIST 1.1, or death due to any cause

OS is defined as the time from the date of randomization to the date of death due to any cause.

Percentage of participants with confirmed best overall intracranial response (BOIR) of CR or partial response (PR), as assessed by BIRC review per RANO-BM criteria.

Time from date of first documented intracranial response (CR or PR) to first documented intracranial progression per RANO-BM assessed by BIRC or date of death due to underlying cause of cancer.

Time from date of randomization to first documented intracranial response of either CR or PR, per RANO-BM criteria and assessed by BIRC, which must be subsequently confirmed.

Percentage of participants with a BOR of confirmed CR, PR and stable disease (SD) (or non-CR/non-PD) per RANO-BM, assessed by BIRC.

Plasma concentrations of capmatinib. Blood samples will be collected at indicated time points for pharmacokinetic analysis.

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Change from baseline in EORTC QLQ-C30 scores will be assessed

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The five domains of the questionnaire include pain, dyspnea, coughing and hemoptysis, and are based on their presence over the past week. All but the pain domain are scored on a 4 point Likert scale ranging from "not at all" to "very much". Pain is score based on its presence, hence yes or no. A higher score indicates a higher presence of symptoms.

Change from baseline in EORTC QLQ-LC13 scores will be assessed

EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients. The EQ-5D-5L consists of 2 parts- the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: from 1 (no problems) to 5 (extreme problems). The EQ VAS is a self-perceived health score assessed using a visual analogue scale that ranges from 0 (the worst imaginable health) to 100 (the best imaginable health), with higher scores indicating higher health utility.

Change from baseline in EQ-5D-5L scores will be assessed

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire. The five domains of the questionnaire include pain, dyspnea, coughing and hemoptysis, and are based on their presence over the past week. All but the pain domain are scored on a 4 point Likert scale ranging from "not at all" to "very much". Pain is score based on its presence, hence yes or no. A higher score indicates a higher presence of symptoms.

Time to symptom deterioration for chest pain, cough and dyspnea will be assessed

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. The questionnaire is composed of both multi-item scales and single-item measures based on the participants experience over the past week. These include five domains (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/HRQoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

Time to deterioration in QoL from EORTC-QLQ-C30 will be assessed.

Participants received one or two prior lines of treatment

400 mg of capmatinib tablets, administered orally twice daily

The purpose of the study is to learn whether the study treatment (capmatinib), which already shows efficacy and safety in non-Chinese patients, could help Chinese patients with controlling their lung cancer in a safe way. Participants will have a type of lung cancer called non-small cell lung lancer (NSCLC), with a specific alteration in a part of their DNA (called mutation) of the MET gene, within a specific part of this gene called exon 14.

Participants who have advanced (or metastatic) non-small cell lung cancer with specific mutations in the MET gene but without mutations in the EGFR or ALK genes, who are aged 18 years or older will be enrolled in this study.

The study drug, capmatinib (also known as INC280), is an oral drug that is called a 'targeted' medicine, which means it targets particular processes that may not be working properly in cancer cells (called dysregulation). The dysregulation of the MET signaling in cancer cells of patients with NSCLC is believed to make the cancer worse. Capmatinib has been shown to selectively block the effects of the MET gene and therefore may help in keeping the disease under control, stopping cancer cells from growing.

This is an open-label, multicenter two-cohort phase II study. Chinese adult participants with EGFR wild-type (wt) (EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative, advanced (stage IIIB, IIIC or IV) NSCLC disease harboring MET exon 14-skipping (METΔex14) mutations as determined by a Novartis central molecular laboratory will be treated in this study. Cohort 1 will include treatment naive participants and Cohort 2 participants who failed one or two prior lines of therapy in the advanced stage (stage IIIB, IIIC or IV). Each participant will receive 400 mg capmatinib tablet twice daily (BID).

The primary endpoint is the overall response rate (ORR) by cohort as per the blinded independent review committee (BIRC) review. ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST 1.1.

The primary analysis will be performed using full analysis set (FAS). The primary efficacy endpoint ORR will be estimated and the exact 95% confidence interval (CI) will be provided by cohort.

Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation

A Phase II, Multicenter, Two-cohort Study of Oral MET Inhibitor Capmatinib in Chinese Adult Patients With EGFR Wild-type (wt), ALK Rearrangement Negative, MET Exon 14 Skipping Mutations, Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Treatment Naive or Failed One or Two Prior Lines of Systemic Therapy

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.

ORR is defined as the proportion of participants with a best overall response (BOR) defined as complete response or partial response (CR+PR) by BIRC assessment per RECIST 1.1

DOR, calculated as the time from the date of the first documented CR or PR by BIRC per RECIST 1.1 to the first documented progression or death due to any cause for participants with PR or CR

ORR (CR+PR) and DOR per RECIST 1.1 by investigator assessment

TTR, calculated as the time from first dose of capmatinib to first documented response (CR+PR) for participants with PR or CR per RECIST 1.1 by BIRC and investigator

DCR, calculated as the proportion of participants with BOR of CR, PR, or SD (stable disease) per RECIST 1.1 by BIRC and investigator

PFS, defined as time from first dose of capmatinib to progression or death due to any cause per RECIST 1.1 by BIRC and investigator

OS is defined as the time from first dose to the date of death due to any cause.

Overall intracranial response rate (OIRR) calculated as the proportion of participants with a confirmed best overall intracranial response (BOIR) of CR or PR per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria as assessed by BIRC

Intracranial disease control rate (IDCR), defined as the proportion of participants with a confirmed BOIR of CR or PR or SD (or non-CR/non-Progressive Disease) per RANO-BM criteria as assessed by BIRC review.

Time to intracranial response (TTIR) defined as the time from the date of the start of study treatment to the date of the first documented intracranial response of either CR or PR per RANO-BM criteria as assessed by BIRC

Duration of intracranial response (DOIR) defined as the time from the date of first documented intracranial response of either CR or PR to the date of the first documented intracranial progression per RANO-BM criteria as assessed by BIRC review or date of death due to any cause.

ORR, DOR and PFS per RECIST 1.1 for participants by MET mutation status assessed in circulating tumor DNA (ctDNA) at baseline, both by BIRC and investigator. The association between MET mutation status as measured in ctDNA at baseline with ORR, DOR and PFS will be established using Kaplan-Meier curve by cohort separately. Median survival together with their 95% confidence intervals will be reported.

Steady state Ctrough and steady state 0.5- 1.5 hour and 3-5 hours post-dose concentrations

EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients.

EORTC QLQ-LC13 is a 13-item lung cancer specific questionnaire.

EQ-5D-5L is a standardized measure to assess the overall health-related quality of life in patients.

National Comprehensive Cancer Network Functional Assessment of Cancer Therapy (NCCN FACT) - Brain Symptom Index version 2.0 (FBrSI) symptom module, consisting of 24 items with a recall period of the past 7 days, will explore changes in symptoms associated with potential brain metastases.

Amino Acids

Crizotinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib

Pfizer CT.gov Call Center

To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation

Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC

Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus

Overall objective response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review \[IRR\]), relative to the total population of response-evaluable participants. Per RECIST v1.1, CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.

DR: time from first documentation of objective tumor response (CR or PR) to first documentation of objective progressive disease (PD) or to death due to any cause, whichever occurred first. If no progression or death on study was observed, or given antitumor treatment other than study drug, participants were censored on date of last on-study tumor assessment. RECIST v1.1, a) PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study), sum must also demonstrate an absolute increase of \>=5 mm, appearance of 1 or more new lesions, unequivocal progression of existing non-target lesions; b) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); c) PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters.

TTR was defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. RECIST v1.1 (as determined by IRR), a) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); b) PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

DCR at 8 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or stable disease (SD) at 8 weeks, respectively, relative to the total population of response evaluable participants. RECIST v1.1 (as determined by IRR), a) CR: disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis); b) PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

PFS was defined as the time from the date of the first dose of crizotinib to first documentation of objective PD or to death on study due to any cause, whichever occurred first. If no progression or death on study was observed, or given antitumor treatment other than study drug, participants were censored on date of last on-study tumor assessment. RECIST v1.1, PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression. Unequivocal progression of existing non-target lesions.

OS was defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive.

Treatment-emergent AEs :between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to crizotinib was assessed by the investigator. Treatment-related AE: any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE):an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death.

Laboratory values included hemoglobin increased, anemia, platelet count decreased, leukocytosis, white blood cell decreased, lymphocyte count increased, lymphocyte count decreased and neutrophil count decreased. Laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher.

Laboratory values included blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, alkaline phosphatase increased, hypoalbuminemia, hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, hypophosphatemia, Creatinine increased, hyperuricemia, hypermagnesemia, hypomagnesemia, hyperglycemia and hypoglycemia. Laboratory values were defined as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0) grade 3 or higher.

The EORTC QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance/insomnia, constipation, and diarrhea) and the perceived financial burden of treatment. All the scales and single-item scores ranged from 0 to 100, higher score is indicative of a higher response level (high score for a functional scale represents a high / healthy level of functioning; high score for the global health status / QoL represents a high QoL; a high score for a symptom scale / item represents a high level of symptomatology / problems).

The EORTC QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia). Scores on each scale and item ranged from 0 to 100, higher score is indicative of a higher response level (a high score for a symptom scale / item represents a high level of symptomatology / problems).

OxOnc Development LP

Pfizer

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Participants received crizotinib 250 mg orally twice a day in a cycle of 28 days. Dose was modified by investigator if there was treatment-related toxicity. Maximum treatment exposure time was of 291.9 weeks up to final analysis date.

Crizotinib 250 mg

Age, Continuous

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Asia

Region of Enrollment

The Safety Population contains all enrolled participants who received at least one dose of study medication.

Due to small percentage of participants (less than 20%) after Cycle 60, data for EORTC QLQ-C30 score and EORTC QLQ-LC13 score could not be interpreted.

65 participants died during the whole study: 15 participants died within 28 days from last dose of study treatment and were reported as SAEs, while 50 participants died during the survival follow-up.

Pfizer ClinicalTrials.gov Call Center

The response-evaluable population (RES) population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.

Independent Radiology Reviewed Overall Objective Response (ORR)

The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment. Here, "Overall Number of Participants Analyzed" signifies number of participants with a confirmed objective response that could have occurred anytime up to 151.3 weeks.

IRR-Assessed Duration of Response (DR)

IRR-Assessed Time to Tumor Response (TTR)

The RES population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline tumor assessment.

IRR Assessed Disease Control Rate (DCR) at 8 Weeks

The safety analysis population (SAF) included all enrolled participants who received at least 1 dose of study medication.

IRR-Assessed Progression Free Survival (PFS)

SAF included all enrolled participants who received at least 1 dose of study medication.

Overall Survival (OS)

Incidence of All-Causality Adverse Events

Incidence of All-Causality Serious Adverse Events

Incidence of Treatment Related Adverse Events

Incidence of Treatment Related Serious Adverse Events

Incidence of All-Causality Grade 3-4 Adverse Event

Incidence of Treatment Related Grade 3-4 Adverse Event

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs, Treatment Emergent Treatment Related AEs and SAEs, Grade 3 or 4 Treatment Emergent AEs and Grade 3 or 4 Treatment Emergent Treatment Related AEs

Hemoglobin Increased: Baseline Grade 0 to Worst Grade 3

Hemoglobin Increased: Baseline Grade 1 to Worst Grade 3

Hemoglobin Increased: Baseline Grade 2 to Worst Grade 3

Hemoglobin Increased: Baseline Grade 0 to Worst Grade 4

Hemoglobin Increased: Baseline Grade 1 to Worst Grade 4

Hemoglobin Increased: Baseline Grade 2 to Worst Grade 4

Anemia: Baseline Grade 0 to Worst Grade 3

Anemia: Baseline Grade 1 to Worst Grade 3

Anemia: Baseline Grade 2 to Worst Grade 3

Anemia: Baseline Grade 0 to Worst Grade 4

Anemia: Baseline Grade 1 to Worst Grade 4

Anemia: Baseline Grade 2 to Worst Grade 4

Platelet Count Decreased: Baseline Grade 0 to Worst Grade 3

Platelet Count Decreased: Baseline Grade 1 to Worst Grade 3

Platelet Count Decreased: Baseline Grade 2 to Worst Grade 3

Platelet Count Decreased: Baseline Grade 0 to Worst Grade 4

Platelet Count Decreased: Baseline Grade 1 to Worst Grade 4

Platelet Count Decreased: Baseline Grade 2 to Worst Grade 4

Leukocytosis: Baseline Grade 0 to Worst Grade 3

Leukocytosis: Baseline Grade 1 to Worst Grade 3

Leukocytosis: Baseline Grade 2 to Worst Grade 3

Leukocytosis: Baseline Grade 0 to Worst Grade 4

Leukocytosis: Baseline Grade 1 to Worst Grade 4

Leukocytosis: Baseline Grade 2 to Worst Grade 4

White Blood Cell Decreased: Baseline Grade 0 to Worst Grade 3

White Blood Cell Decreased: Baseline Grade 1 to Worst Grade 3

White Blood Cell Decreased: Baseline Grade 2 to Worst Grade 3

White Blood Cell Decreased: Baseline Grade 0 to Worst Grade 4

White Blood Cell Decreased: Baseline Grade 1 to Worst Grade 4

White Blood Cell Decreased: Baseline Grade 2 to Worst Grade 4

Lymphocyte Count Increased: Baseline Grade 0 to Worst Grade 3

Lymphocyte Count Increased: Baseline Grade 1 to Worst Grade 3

Lymphocyte Count Increased: Baseline Grade 2 to Worst Grade 3

Lymphocyte Count Increased: Baseline Grade 0 to Worst Grade 4

Lymphocyte Count Increased: Baseline Grade 1 to Worst Grade 4

Lymphocyte Count Increased: Baseline Grade 2 to Worst Grade 4

Lymphocyte Count Decreased: Baseline Grade 0 to Worst Grade 3

Lymphocyte Count Decreased: Baseline Grade 1 to Worst Grade 3

Lymphocyte Count Decreased: Baseline Grade 2 to Worst Grade 3

Lymphocyte Count Decreased: Baseline Grade 0 to Worst Grade 4

Lymphocyte Count Decreased: Baseline Grade 1 to Worst Grade 4

Lymphocyte Count Decreased: Baseline Grade 2 to Worst Grade 4

Neutrophil Count Decreased: Baseline Grade 0 to Worst Grade 3

Neutrophil Count Decreased: Baseline Grade 1 to Worst Grade 3

Neutrophil Count Decreased: Baseline Grade 2 to Worst Grade 3

Neutrophil Count Decreased: Baseline Grade 0 to Worst Grade 4

Neutrophil Count Decreased: Baseline Grade 1 to Worst Grade 4

Neutrophil Count Decreased: Baseline Grade 2 to Worst Grade 4

SAF included all enrolled participants who received at least 1 dose of study medication. Here, "number analyzed" signifies participants evaluable at specific rows.

Number of Participants With a Shift in Hematology Laboratory Results From Baseline Grade </=2 to Worst Grade 3 or Grade 4

Blood Bilirubin Increased: Baseline Grade 0 to Worst Grade 3

Blood Bilirubin Increased: Baseline Grade 1 to Worst Grade 3

Blood Bilirubin Increased: Baseline Grade 2 to Worst Grade 3

Blood Bilirubin Increased: Baseline Grade 0 to Worst Grade 4

Blood Bilirubin Increased: Baseline Grade 1 to Worst Grade 4

Blood Bilirubin Increased: Baseline Grade 2 to Worst Grade 4

Alanine Aminotransferase Increased: Baseline Grade 0 to Worst Grade 3

Alanine Aminotransferase Increased: Baseline Grade 1 to Worst Grade 3

Alanine Aminotransferase Increased: Baseline Grade 2 to Worst Grade 3

Alanine Aminotransferase Increased: Baseline Grade 0 to Worst Grade 4

Alanine Aminotransferase Increased: Baseline Grade 1 to Worst Grade 4

Alanine Aminotransferase Increased: Baseline Grade 2 to Worst Grade 4

Aspartate Aminotransferase Increased : Baseline Grade 0 to Worst Grade 3

Aspartate Aminotransferase Increased : Baseline Grade 1 to Worst Grade 3

Aspartate Aminotransferase Increased : Baseline Grade 2 to Worst Grade 3

Aspartate Aminotransferase Increased : Baseline Grade 0 to Worst Grade 4

Aspartate Aminotransferase Increased : Baseline Grade 1 to Worst Grade 4

SAF included all enrolled participants who received at least one dose of study medication. Here, "number analyzed" signifies participants evaluable at specific rows.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	NCT04427072	Carcinoma, Non-...	Capmatinib Docetaxel	18 Years -	Novartis
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	NCT04427072	Carcinoma, Non-...	Capmatinib Docetaxel	18 Years -	Novartis
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	NCT04427072	Carcinoma, Non-...	Capmatinib Docetaxel	18 Years -	Novartis
Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	NCT04677595	Non-Small Cell ...	Capmatinib	18 Years -	Novartis
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC	NCT01945021	Non Small Cell ... ROS1 Proto Onco... Crizotinib	Crizotinib	18 Years -	Pfizer
Study of Capmatinib in Chinese Adult Patients With Advanced Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation	NCT04677595	Non-Small Cell ...	Capmatinib	18 Years -	Novartis

Spots Global Cancer Trial Database for alk negative

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