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KRYSTAL - 7 Trial Information

Learn more about the KRYSTAL-7 / 849-007 / CA239-0009 study

High unmet need remains in mNSCLC for optimal combination approaches despite advances with chemoimmunotherapy
- mPFS<1 year and <35% of patients alive at 5 years.1,2

KRYSTAL-7 aims to investigate improved outcomes for patients with KRASG12C mutations and PD-L1 expression status >= 50% by combining adagrasib with SOC (pembrolizumab monotherapy) in first-line treatment.

  • Adagrasib and pembrolizumab combination achieved a 59% ORR and 27.7-month PFS in KRASG12C–mutated NSCLC with PD-L1 TPS ≥50%.2
  • Safety profiles were consistent with known effects, with 95% experiencing any-grade TRAEs that were addressed with dose adjustments as necessary.3
3D rendering of a lung cancer cell KRAS G12C mutation on a red background.

KRYSTAL-7 is the Phase 3 portion of study CA239-0009. It is an open-label, randomized clinical trial in the first-line treatment setting in patients with NSCLC (squamous or non-squamous, unresectable , locally advanced or metastatic) with KRASG12Cmutation and PD-L1 ≥50% comparing the efficacy of:

Adagrasib + Standard of Care

Adagrasib administered in combination with pembrolizumab

VS

Standard of Care

Pembrolizumab monotherapy

two overlapping squares with the overlapping section filled in and the non-overlapping portions empty

Key Inclusion Criteria4,5

  • ≥18 years of age
  • Histologically confirmed diagnosis: patients must have a histologically or cytologically confirmed diagnosis of NSCLC, either squamous or non-squamous, with a KRASG12C mutation and a PD-L1 ≥50%, confirmed using sponsor-approved local or central testing.
  • Disease state: unresectable or metastatic.
  • Measurable disease: Disease per RECIST v1.1 is present.
  • Representative tumor specimen
    A representative tumor specimen (primary or metastatic) and newly obtained or archival sample must be available to be submitted to the Sponsor during screening or within 30 days of randomization.
  • Therapy candidacy: Patients must not be candidates for definitive therapy (eg, chemoradiation for locally advanced disease).
  • Life expectancy: patients must have a life expectancy of at least 3 months
two overlapping squares with the overlapping section empty and the non-overlapping portions filled in

Key Exclusion Criteria4,5

  • Prior systemic treatment: patients who have received prior systemic treatment for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitors, or therapies targeting KRASG12C mutation (eg, sotorasib) cannot be included but
prior systemic therapy or chemoradiation given in the adjuvant and neoadjuvant treatment setting are allowed, as long as the last dose of prior systemic treatment is more than 6 months prior to the first dose of study treatment.
  • Radiation: patient cannot have received radiation to the lung >30 Gy within 6 months prior to the first dose of study treatment
  • Presence of carcinomatous meningitis.
  • CNS lesions: patients with known CNS lesions must not have:
    • Untreated or symptomatic brain lesions larger than 2.0 cm
    • Any brainstem lesions
    • Ongoing use of systemic corticosteroids for control of symptoms of brain lesions exceeding a total daily dose of 10 mg of prednisone (or equivalent)
    • Poorly controlled generalized or complex partial seizures or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
    • Autoimmune disease: active or prior documented autoimmune cannot be present.

*Other protocol-defined inclusion-exclusion criteria may apply

References

  1. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csőszi T, Fülöp A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349.
  2. Garassino MC, Theelen WSME, Jänne PA, et al. First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) and PD-L1 ≥ 50% from the phase 2 portion of KRYSTAL-7. Presented at: 2025 European Lung Cancer Congress; March 26-29, 2025; Paris, France. Abstract 5MO.
  3. Garassino MC, Theelan WSME, Jotte R, et al. LBA65 KRYSTAL-7: Efficacy and safety of adagrasib with pembrolizumab in patients with treatment-naïve, advanced non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation. Ann Oncol. 2023;34(suppl 2): S1309-S1310.
  4. ClinicalTrials.gov. Accessed March 2025. https://clinicaltrials.gov/study/NCT04613596
  5. Garassino ME et al. Presented at European Society of Medical Oncology (ESMO) Congress; September 13-17, 2024; Barcelona, Spain. 1394TiP.

Abbreviations

m NSCLC = metastatic non-small cell lung cancer; mPFS = median progression-free survival; SOC = standard-of-care; NCCN = National Comprehensive Cancer Network; ORR = Overall Response Rate; PFS = progression-free survival; PD-L1 = programmed death-ligand 1; TPS = tumor proportion score; RECIST = response evaluation criteria in solid tumors; CNS = central nervous system

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Find the right adagrasib clinical trial for your NSCLC patient

This website provides general information about ongoing BMS clinical trials and a source of scientific information related to BMS investigational product adagrasib. The information included pertains to an investigational therapy that has not yet been approved for use in any country. The safety and efficacy of investigational therapies and/or uses have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

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