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

NCT04139317 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-10-09

Study results available
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Summary

The purpose was 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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Capmatinib

INC280 tablets were administered orally at 400 mg on a continuous twice daily (BID) dosing schedule, from Day 1 until Day 21 of each 21-day cycle.

BIOLOGICAL

Pembrolizumab

Pembrolizumab was administered by intravenous infusion at 200 mg once every 3 weeks (Q3W).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2022-01-14
Completion
2023-02-07
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04139317 on ClinicalTrials.gov