A study of Adagrasib plus Pembrolizumab plus chemotherapy versus placebo plus Pembrolizumab plus chemotherapy in participants with previously untreated non-squamous non-small cell lung cancer with KRAS-G12C mutation (KRYSTAL-4)

Kriterien zur Teilnahme
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of a KRAS G12C mutation through tumor tissue and/or circulating tumor DNA (ctDNA). - Locally advanced or metastatic disease. - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criterion of at least 1 lesion. - No prior systemic cancer therapy for advanced or metastatic disease. - Not a candidate for definitive therapy (e.g., chemoradiotherapy or complete surgical resection). - Participants with brain metastases may be included, including those with untreated brain metastases. Brain metastases must be asymptomatic and must not be treated locally immediately. Untreated brain metastases must have a diameter of ≤ 20 mm. - Any PD-L1 expression (0 to 100%), determined by the VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx. (BASEC)

Ausschlusskriterien
- Participants with an active, known, documented, or suspected autoimmune or inflammatory disease. - Uncontrolled or significant cardiovascular diseases within 6 months prior to enrollment. - Insufficient bone marrow or liver function or electrocardiogram (ECG) abnormalities. - Ongoing treatment with concomitant medication known to cause a prolonged QTc interval and cannot be switched to an alternative treatment prior to study entry. - Treatment targeting the KRAS G12C mutation (e.g., Sotorasib, Adagrasib) in any setting. - Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or administration of study drugs. - Other protocol-defined inclusion/exclusion criteria apply. (BASEC)