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Small Molecule Drug

Adagrasib Combo Therapy for Lung Cancer (202200050434 Trial)

Phase 2

Recruiting

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort A: Untreated and unresectable or metastatic NSCLC with histologically confirmed KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%

Be older than 18 years old

Must not have

Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment

Active brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: pre-dose and 4-6 hours post dose; up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug combo to treat advanced lung cancer with a genetic mutation.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called KRAS G12C. Participants must have measurable disease and varying levels of PD-L1 expression, depending on the cohort they fall into. They should not have received certain prior treatments for NSCLC or have active brain metastases.

What is being tested?

The study tests adagrasib combined with pembrolizumab and chemotherapy (pemetrexed, cisplatin/carboplatin) in patients with NSCLC who haven't been treated before or those who've had stable disease after initial chemo. It's an open-label Phase 2 trial to see how well this combination works.

What are the potential side effects?

Possible side effects include fatigue, nausea, diarrhea, liver enzyme changes, skin rash, and potential immune-related issues like inflammation of organs due to pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is 1% or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had lung radiation over 30 Gy in the last 6 months.

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I have active cancer spread to my brain.

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I have never received treatment targeting the KRASG12C mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: pre-dose and 4-6 hours post dose; up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: pre-dose and 4-6 hours post dose; up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: pre-dose and 4-6 hours post dose; up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) for Cohort A and E

Progression-free Survival (PFS) at six months for Cohort C

Secondary study objectives

Adverse Events

Cohorts C and E: DLTs during SLI (Safety Lead In)

Duration of Response (DOR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort EExperimental Treatment4 Interventions

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)

Group II: Cohort CExperimental Treatment4 Interventions

Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles

Group III: Cohort A: PD-L1 TPS≥ 1% (Closed)Experimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810