臨床研究等提出・公開システム

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 Advancedor Metastatic Non-squamous Non-small Cell Lung
Cancer with KRASG12C Mutation(KRYSTAL-4) (KRYSTAL-4)

Study of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus
Chemotherapy in Participants with Previously Untreated, Locally Advancedor Metastatic Non-squamous NSCLCwith KRASG12C Mutation(KRYSTAL-4) (CA239-0004)

Jimenez-Kurlander Lauren

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Jimenez-Kurlander Lauren

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Recruiting

Jan. 27, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

>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.

>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.

Both

Non-small Cell Lung Cancer

Arm A
Drug: Adagrasib
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin
Arm B
Drug: Placebo
Drug: Pembrolizumab
Drug: Pemetrexed
Drug: Cisplatin
Drug: Carboplatin

PFS by BICR
Overall Survival (OS)

PFS by Investigator
OR by Investigator and BICR
Duration of Response (DOR) by Investigator
and BICR

Patient-reported outcome (PRO) scores

+81-53-435-2111

Jan. 13, 2026

Yes

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

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