Study of efficacy of capmatinib in comparison with standard of care docetaxel as a second or third line therapy in participants with non-small cell lung cancers harboring MET exon 14 skipping mutation.
- Conditions
- cMET mutated NSCLCMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-001578-31-LT
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1.Signed informed consent must be obtained prior to participation in the study.
2.Adult = 18 years old at the time of informed consent.
3.Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality therapy) or IV NSCLC at the time of study entry.
4.Histologically or cytologically confirmed diagnosis of NSCLC that is:
•EGFR wt. This should have been assessed as part of the participant’s standard of care by a validated test for EGFR mutations as per local guidelines.
•AND ALK rearrangement negative. This should have been assessed as part of the participant’s standard of care by a validated test.
•AND has MET?ex14 mutation per Novartis-designated central laboratory.
5.Mandatory provision of a formalin-fixed, paraffin embedded tumor tissue sample (archival tumor block or slides, or a newly obtained tumor sample) in a quantity sufficient to allow the confirmation of MET mutation status for all participants and potential companion diagnostics development. Tumor samples must contain at least 10% tumor content.
6.Participants must have progressed on one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB/IIIC [not candidates for surgery, radiation or multi modality therapy] or IV NSCLC) and must be candidates for single agent chemotherapy (docetaxel).
7.ECOG performance status (PS) of 0 or 1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
1.Prior treatment with any MET inhibitor or HGF-targeting therapy.
2.Participants with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms. If participants are on corticosteroids for endocrine deficiencies or tumor-associated symptoms other than CNS related, dose must have been stabilized (or decreasing) for at least 5 days before Cycle 1 Day 1.
3.Participants with known druggable molecular alterations (such as ROS1 translocation or BRAF mutation, etc.) which might be a candidate for alternative targeted therapies as applicable per local regulations and treatment guidelines.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method