Carcinoma, Non-Small-Cell Lung
Conditions
Interventions
Capmatinib
Capmatinib will be administered orally.
Phase 1 (Combination Dose Selection):capmatinib 400 milligrams (mg) orally twice daily
Phase 2 (Dose Expansion): will receive capmatinib in combinati
Sponsors
Anazawa Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: '- Previously diagnosed with histologically or cytologically confirmed unresectable Stage IV (metastatic) non-small cell lung cancer (NSCLC) (any histology) - May have: definitively, locally treated brain metastases that are clinically stable and asymptomatic for greater than (>) 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams (mg) prednisone or equivalent) for at least 2 weeks prior to start of study treatment - May have a prior malignancy (other than the disease under study) the natural history or treatment of which is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Exclusion criteria
Exclusion criteria: - Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening - Participant has impairment of the gastrointestinal function that could affect absorption of capmatinib or is unable or unwilling to swallow tablets - Participant has symptomatic central nervous system (CNS) metastases which are neurologically unstable or have required increasing doses of steroids >10 mg prednisone or equivalent within the 2 weeks prior to study entry to manage CNS symptoms - Participant has uncontrolled tumor-related pain: Symptomatic lesions amenable to palliative radiotherapy (example, bone metastases, or metastases causing nerve impingement) should be treated more than 7 days prior to the administration of the first study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Phase 1: Number of Participants with Adverse events (AEs) by Severity Up to 2 years 1 month An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. - Phase 1: Number of Participants with Dose Limiting Toxicities (DLTs) Cycle 1 (Day 1 through Day 28) The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, liver enzyme elevation, or treatment delay greater than (>) 28 days due to unresolved toxicity. - Phase 2: Objective Response Rate Up to 2 years 1 month ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Phase 1: Number of Participants with AEs by Severity Up to 2 years 1 month An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the intervention. Severity will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. -Phase 1: Number of Participants with Abnormalities in Clinical Laboratory Parameters Up to 2 years 1 month Number of participants with abnormalities in clinical laboratory parameters (serum chemistry, hematology, coagulation, serology, and urinalysis) will be reported. -Phase 2 : Duration of Response (DoR) Up to 2 years 1 month DoR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death from any case, whichever comes first, for participants who have PR or CR. -Phase 2: Disease Control Rate (DCR) Up to 2 years 1 month DCR is defined as the percentage of participants who achieve a PR, CR, or stable disease using RECIST version 1.1. -Phase 2: Progression Free Survival (PFS) Up to 2 years 1 month PFS is defined as the time from first dose date until the date of disease progression or death, whichever comes first, based on investigator assessment using RECIST version 1.1 -Phase 2: Overall Survival (OS) Up to 2 years 1 month OS is defined as the time from the date of administration of the first study treatment until the date of death due to any cause. -Phase 2: Time to Subsequent Therapy (TTST) Up to 2 years 1 month TTST is defined as the time from the date of administration of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation, or death, whichever comes first. -Phase | — |
Countries
China, Japan, Republic Of Korea, Spain, Turkey, United Kingdom Of Great Britain, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed