RecruitingPhase 2 / Phase 3

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for people starting their first treatment for advanced non-small cell lung cancer (NSCLC) with a KRAS G12C gene change. Phase 2 tests how well adagrasib (MRTX849) works and how safe it is, alone or with pembrolizumab. Phase 3 compares the two drugs together with pembrolizumab alone in people whose cancer has a PD-L1 test score of at least 50%.

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both phases: A tissue test must confirm NSCLC with a KRAS G12C gene change. The cancer cannot be removed by surgery or has spread to other parts of the body.
  • Phase 2: Any PD-L1 test score is allowed. PD-L1 is a protein measured in cancer tissue.
  • Phase 3: The cancer may be either squamous or nonsquamous, two types of NSCLC. The PD-L1 test score must be at least 50%.
  • Phase 3: The cancer must be measurable using the study’s standard rules.
  • Phase 3: A brain scan must show no cancer in the brain, or brain cancer spread that does not need immediate treatment in that area. Past treatment for brain cancer spread is allowed.

Who can't join

  • Both phases: Past treatment with drugs that travel through the body for locally advanced or spreading NSCLC. This includes chemotherapy, immune checkpoint drugs, or drugs targeting KRAS G12C.
  • Phase 2: Active cancer spread to the brain.
  • Phase 3: Any untreated area of cancer in the brain larger than 2 centimeters.
  • Phase 3: Any cancer in the brainstem, which connects the brain to the spinal cord.
  • Phase 3: Ongoing steroid medicine for brain cancer symptoms at more than 10 mg of prednisone per day, or an equal dose of another steroid, before assignment to a study group.
  • Phase 3: Poorly controlled seizures affecting the whole brain or causing loss of awareness more than once a week, or worsening brain or nerve symptoms from brain cancer despite treatment.
  • Phase 3: Radiation to the lung at a dose above 30 Gy within 6 months before the first study dose. Gy is a unit of radiation dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS * Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50% * Phase 3: Presence of measurable disease per RECIST1.1 * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated brain metastases not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy Exclusion Criteria: * Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Phase 2: Active brain metastases * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated brain lesions \> 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy * Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Study sites (220)

AR

AZ

CA

CO

CT

DC

FL

GA

HI

IL

IN

KS

KY

LA

MA

MD

MN

MS

NC

NE

NJ

NV

NY

OH

OR

PA

RI

SC

SD

TN

TX

UT

VA

WA

  • USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center · Vancouver, WA 98684Anthony Van Ho, Site 007-885 · Study contact · 503-885-5411More trials in Vancouver

WI

WV