Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS <50% and KRAS G12C mutation

Official Title

A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Keywords

Advanced NSCLC, Metastatic Lung Cancer, KRAS G12C, NSCLC, Non Small Cell Lung Cancer, Lung Neoplasms, Carboplatin, Pembrolizumab, Pemetrexed, Adagrasib, Adagrasib oral dose of 400 mg twice daily tablets, Chemotherapy: Pemetrexed, Cisplatin/Carboplatin, PD-L1 TPS≥ 1% (Closed)

Eligibility

For people ages 18 years and up

Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.

  • Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received <4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
  • Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS < 50%
  • Presence of measurable disease per RECIST v1.1

Exclusion Criteria:

  • All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
  • Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was >1 year prior to first dose of study treatment)
  • Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
  • Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment
  • Active brain metastases

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Local Institution - 017-961 withdrawn
    Los Angeles California 90095 United States
  • Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05609578
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated