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 (MET*ex14)
- Conditions
- non small cell lung cancer with a C-MET mutation10038666
- Registration Number
- NL-OMON52922
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
* Stage IIIB/IIIC (not amenable to surgery, radiation or multi modality
therapy) or IV NSCLC at the time of study entry.
* Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR wt
(for EGFR mutations that predict sensitivity to EGFR therapy, including, but
not limited to exon 19 deletions and exon 21 L858R substitution mutations), ALK
rearrangement negative as assessed by a validated test as part of the
participant*s standard of care and has MET*ex14 mutation determined by
Novartis-designated central laboratory or by a locally performed, tissue-based
test, validated according to local regulation.
* At least one measurable lesion as defined by RECIST 1.1.
* 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
docetaxel naive and be candidates for single agent chemotherapy (docetaxel).
Participants must have progressed on or after the last therapy before study
entry.
* ECOG performance status of 0 or 1.
* Prior treatment with any MET inhibitor or HGF-targeting therapy
* Participants with known druggable molecular alterations (such as ROS1 and RET
rearrangements, BRAF mutation, KRAS mutation, NTRK fusions, etc.) which might
be a candidate for alternative targeted therapies.
* Presence or history of interstitial lung disease or interstitial pneumonitis,
including clinically significant radiation pneumonitis (i.e., affecting
activities of daily living or requiring therapeutic intervention).
* Long QT syndrome, family history of idiopathic sudden death or congenital
long QT syndrome.
* Clinically significant, uncontrolled heart diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the efficacy of capmatinib versus docetaxel by blinded independent<br /><br>review committee (BIRC)-confirmed progression free survival as per RECIST 1.1. </p><br>
- Secondary Outcome Measures
Name Time Method