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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)

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMirati Therapeutics Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adagrasib

    Drug

    Specified dose on specified days

  • Pembrolizumab

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

Treatment groups

630 Participants
are divided into 2 treatment groups
Group A: AdagrasibExperimental treatment 5 interventions
Group B: PlaceboPlacebo comparator 5 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)

Time frame
Up to 7 years
2

Overall Survival (OS)

Time frame
Up to 7 years

Secondary outcomes

1

Overall Response (OR) as Assessed per RECIST v1.1 by BICR

Time frame
Up to 7 years
2

Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR

Time frame
Up to 7 years
3

PFS as Assessed per RECIST v1.1 by Investigator

Time frame
Up to 7 years
4

Number of Participants With Adverse Events (AEs)

Time frame
Up to 90 days from last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mirati Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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