90 Participants Needed

Adagrasib Combo Therapy for Lung Cancer

(202200050434 Trial)

Recruiting at 160 trial locations
MT
Fl
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mirati Therapeutics Inc.
Must be taking: Platinum-based chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had prior therapy targeting the KRASG12C mutation or certain treatments for advanced NSCLC, you may not be eligible to participate.

What makes the drug Adagrasib unique for lung cancer treatment?

Adagrasib is unique because it specifically targets the KRAS G12C mutation found in some lung cancers, locking the mutant protein in an inactive state to stop cancer growth. It is taken orally and has shown promising response rates with lower liver toxicity compared to other similar treatments.12345

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have NSCLC with a KRASG12C mutation, PD-L1 < 50%, and responded to or couldn't tolerate initial chemotherapy.
My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is below 50%.
My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is 1% or more.
See 1 more

Exclusion Criteria

I received maintenance therapy with pembrolizumab or pemetrexed after initial platinum-based treatment.
I have not had lung radiation over 30 Gy in the last 6 months.
I've had treatment for advanced lung cancer but not within the last year.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adagrasib in combination with pembrolizumab and chemotherapy

Up to 31 cycles
Every 3 weeks

Safety Lead In (SLI)

Participants are monitored for dose-limiting toxicities during the initial treatment cycle

1 cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 months

What Are the Treatments Tested in This Trial?

Interventions

  • Adagrasib
  • Pembrolizumab
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Cohort EExperimental Treatment4 Interventions
Group II: Cohort CExperimental Treatment4 Interventions
Group III: Cohort A: PD-L1 TPS≥ 1% (Closed)Experimental Treatment1 Intervention

Adagrasib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Krazati for:
🇪🇺
Approved in European Union as Krazati for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials
73
Recruited
8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Published Research Related to This Trial

Adagrasib (KRAZATI™) is an effective oral treatment specifically targeting the KRAS G12C mutation in solid tumors, particularly non-small cell lung cancer (NSCLC), by locking the mutant protein in an inactive state, which prevents cancer cell signaling.
In December 2022, adagrasib received accelerated approval in the USA for adults with KRAS G12C-mutated NSCLC who have undergone prior systemic therapy, based on its promising response rates, although further confirmatory trials are needed to establish its clinical benefits.
Adagrasib: First Approval.Dhillon, S.[2023]
In a phase I/IB study involving 25 patients with advanced KRASG12C-mutant solid tumors, adagrasib (600 mg twice daily) demonstrated significant antitumor activity, with 53.3% of patients with non-small-cell lung cancer achieving a confirmed partial response after a median follow-up of 19.6 months.
Adagrasib was well tolerated, with the most common side effects being nausea (80%), diarrhea (70%), and fatigue (45%), indicating a manageable safety profile for patients undergoing treatment.
First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced KRASG12C Solid Tumors (KRYSTAL-1).Ou, SI., Jänne, PA., Leal, TA., et al.[2023]
The KRYSTAL-1 study found that adagrasib (MRTX849), a KRASG12c inhibitor, is generally well tolerated by patients with non-small cell lung cancer, indicating a favorable safety profile.
Adagrasib demonstrated significant efficacy in treating non-small cell lung cancer with the KRASG12c mutation, and it also showed some activity in colorectal cancer and other solid tumors, although to a lesser extent.
Another KRAS Inhibitor Holds Its Own.[2021]

Citations

Adagrasib: First Approval. [2023]
First-in-Human Phase I/IB Dose-Finding Study of Adagrasib (MRTX849) in Patients With Advanced KRASG12C Solid Tumors (KRYSTAL-1). [2023]
Another KRAS Inhibitor Holds Its Own. [2021]
Frontline Promise for Adagrasib-Pembrolizumab Combination. [2023]
Adagrasib: a novel inhibitor for KRASG12C-mutated non-small-cell lung cancer. [2023]
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