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RecruitingPhase 3

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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 tests how well adagrasib works and how safe it is when added to pembrolizumab and two chemotherapy drugs, compared with a placebo (no active drug) added to the same treatment. It is for people with advanced non-squamous non-small cell lung cancer, a type of lung cancer, with a KRAS G12C gene change who have not had whole-body treatment for advanced cancer.

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

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

Eligibility

Who can join

  • Have non-squamous non-small cell lung cancer confirmed by tissue or cell tests, with a KRAS G12C gene change found in a tumor or blood sample.
  • Cancer has spread to nearby areas or other parts of the body.
  • Have at least one cancer spot that can be measured on a CT or MRI scan using study rules.
  • Have not had whole-body cancer treatment for advanced or spreading cancer.
  • Cannot have treatment meant to fully remove or control the cancer, such as complete surgery or chemotherapy with radiation.
  • Cancer that has spread to the brain is allowed if it causes no symptoms and needs no immediate treatment aimed at those spots. Untreated brain spots must be 20 mm (2 cm) wide or smaller.
  • Any level of PD-L1, a protein tested in the cancer, is allowed using an approved study test.

Who can't join

  • Have an active immune system disease that attacks the body, or an inflammatory disease, that needed whole-body treatment within the past 2 years.
  • Have uncontrolled or serious heart or blood vessel problems within the past 6 months that are ongoing or may return.
  • Have bone marrow or liver function that is too low, or abnormal results on an ECG, a test of the heart's electrical activity.
  • Take a drug known to prolong QTc, a change in the heart's electrical timing, and cannot switch drugs before joining.
  • Have ever had treatment aimed at KRAS G12C, such as sotorasib or adagrasib.
  • Have another severe short-term or long-term medical or mental health condition, or an abnormal lab test, that may make the study unsafe.
  • Other study rules for who can and cannot join also apply.

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

Official eligibility criteria

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion. * No prior systemic anti-cancer therapy given for advanced or metastatic disease. * Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection). * Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter. * Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx. Exclusion Criteria: * Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years. * Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence. * Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities. * Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry. * Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (52)

AL

AR

CA

CO

DE

FL

GA

IA

IL

IN

KY

LA

MA

MD

MI

MO

  • SSM Health Cancer Care - Fenton · Fenton, MO 63026Mudresh Mehta, Site 0685 · Study contactMore trials in Fenton

NC

NY

PA

SC

TN

TX