Safety and Efficacy of Capmatinib (INC280) Plus Pembrolizumab vs Pembrolizumab Alone in NSCLC With PD-L1 50%

  • STATUS
    Recruiting
  • End date
    Mar 28, 2023
  • participants needed
    96
  • sponsor
    Novartis Pharmaceuticals
Updated on 25 January 2021
measurable disease
pembrolizumab
EGFR
cancer chemotherapy

Summary

The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Pembrolizumab, capmatinib
Clinical Study IdentifierNCT04139317
SponsorNovartis Pharmaceuticals
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Non-Small Cell Lung Cancer or nsclc?
Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS 50%)
ECOG performance status score 1
Have at least 1 measurable lesion by RECIST 1.1
Have adequate organ function

Exclusion Criteria

Prior treatment with a MET inhibitor or HGF-targeting therapy
Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
Have untreated symptomatic central nervous system (CNS) metastases
Clinically significant, uncontrolled heart diseases
Prior palliative radiotherapy for bone lesions 2 weeks prior to starting study treatment
Other protocol-defined inclusion/exclusion criteria may apply
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