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Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

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Mirati Therapeutics

Status and phase

Enrolling
Phase 2

Conditions

Advanced NSCLC
Metastatic Lung Cancer

Treatments

Combination Product: Cisplatin/Carboplatin
Combination Product: Chemotherapy: Pemetrexed
Combination Product: Pembrolizumab
Drug: Adagrasib oral dose of 400 mg twice daily tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT05609578
849-017
CA239-0010

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

90 participants in 3 patient groups

Cohort A: PD-L1 TPS≥ 1% (Closed)
Experimental group
Description:
Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Treatment:
Drug: Adagrasib oral dose of 400 mg twice daily tablets
Cohort C
Experimental group
Description:
Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Treatment:
Drug: Adagrasib oral dose of 400 mg twice daily tablets
Combination Product: Pembrolizumab
Combination Product: Chemotherapy: Pemetrexed
Combination Product: Cisplatin/Carboplatin
Cohort E
Experimental group
Description:
Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)
Treatment:
Drug: Adagrasib oral dose of 400 mg twice daily tablets
Combination Product: Pembrolizumab
Combination Product: Chemotherapy: Pemetrexed
Combination Product: Cisplatin/Carboplatin

Trial contacts and locations

126

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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