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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT05609578
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced NSCLC
  • Metastatic Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib oral dose of 400 mg twice daily tablets — DRUG
    oral dose of 400 mg twice daily tablets
  • Pembrolizumab — COMBINATION_PRODUCT
    IV infusion once every 3 weeks
  • Chemotherapy: Pemetrexed — COMBINATION_PRODUCT
    IV infusion once every 3 weeks
  • Cisplatin/Carboplatin — COMBINATION_PRODUCT
    IV infusion once every 3 weeks

Study Details

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

Key Dates

First listed
Nov 8, 2022
Start date
Nov 22, 2022
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: PD-L1 TPS≥ 1% (Closed)
    Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
  • Experimental: Cohort C
    Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
  • Experimental: Cohort E
    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)

Primary Outcome Measure

Objective Response Rate (ORR) for Cohort A and E [ Time Frame: 30 months ]

Locations (59)

FacilityCityStateZIPSite coordinators
Local Institution - 017-936Fountain ValleyCalifornia92708-
Local Institution - 017-936CFountain ValleyCalifornia92708-
Local Institution - 017-851FullertonCalifornia92835-
Local Institution - 017-540San FranciscoCalifornia94158-
Local Institution - 017-872-IAuroraColorado80012-
Local Institution - 017-872-GBoulderColorado80303-
Local Institution - 017-872-DColorado SpringsColorado80907-
Local Institution - 017-872-JColorado SpringsColorado80920-
Local Institution - 017-872-BDenverColorado80218-
Local Institution - 017-872-FDenverColorado80220-
Local Institution - 017-872-ALakewoodColorado80228-
Local Institution - 017-872-CLittletonColorado80218-
Local Institution - 017-872Lone TreeColorado80124-
Local Institution - 017-872-EPuebloColorado81003-
Local Institution - 017-872-HThorntonColorado80260-
Local Institution - 017-829JacksonvilleFlorida32224-
Local Institution - 017-898LakelandFlorida33812-
Local Institution - 017-972ChicagoIllinois60637-
Local Institution - 017-820JFairwayKansas66205-
Local Institution - 017-820AKansas CityKansas66160-
Local Institution - 017-820BKansas CityKansas66160-
Local Institution - 017-820CKansas CityKansas66160-
Local Institution - 017-820HKansas CityKansas66160-
Local Institution - 017-820IOverland ParkKansas66210-
Local Institution - 017-820WestwoodKansas66205-
Local Institution - 017-388BostonMassachusetts02215-
Local Institution - 017-808BostonMassachusetts02215-
Local Institution - 017-811NoviMichigan48377-
Local Institution - 017-838BMinneapolisMinnesota55404-
Local Institution - 017-838CMinneapolisMinnesota55404-
Local Institution - 017-830RochesterMinnesota55905-
Local Institution - 017-838Saint Louis ParkMinnesota55416-
Local Institution - 017-838ASaint Louis ParkMinnesota55426-5000-
Local Institution - 017-820EKansas CityMissouri64154-
Local Institution - 017-820FKansas CityMissouri64116-
Local Institution - 017-820DLee's SummitMissouri64064-
Local Institution - 017-820GNorth Kansas CityMissouri64116-
Local Institution - 017-080BabylonNew York11702-
Local Institution - 017-088BrooklynNew York11210-
Local Institution - 017-587East SyracuseNew York13057-
Local Institution - 017-087New Hyde ParkNew York11042-
Local Institution - 017-085New YorkNew York10028-
Local Institution - 017-082PatchogueNew York11772-
Local Institution - 017-086Port JeffersonNew York11776-
Local Institution - 017-081Port Jefferson StationNew York11776-
Local Institution - 017-535Port Jefferson StationNew York11776-
Local Institution - 017-084RiverheadNew York11901-
Local Institution - 017-083The BronxNew York10469-
Local Institution - 017-818ClevelandOhio44195-
Local Institution - 017-879DallasTexas75246-
Local Institution - 017-878LongviewTexas75601-
Local Institution - 017-878-BPalestineTexas75801-
Local Institution - 017-878-CParisTexas75460-
Local Institution - 017-878-ATylerTexas75702-
Local Institution - 017-814-AArlingtonVirginia22205-
Local Institution - 017-814FairfaxVirginia22031-
Local Institution - 017-814-BGainesvilleVirginia20155-
Local Institution - 017-814-CRestonVirginia20190-
Local Institution - 017-909BellinghamWashington98225-

Find similar trials in Fountain Valley, CA

By research site
Local Institution - 017-936· Fountain Valley, CALocal Institution - 017-936C· Fountain Valley, CALocal Institution - 017-851· Fullerton, CALocal Institution - 017-540· San Francisco, CALocal Institution - 017-872-I· Aurora, COLocal Institution - 017-872-G· Boulder, CO

Related Studies