Lung Cancer Clinical Trials

• Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.

• Documented EGFRmt status as determined by local testing performed at a clinical laboratory improvement amendment (CLIA) certified (United States \[US\]) or accredited (outside of the US) local laboratory, defined as either one of the following EGFRmt:

‣ exon20 insertion mutations (ex20ins) or

⁃ other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)

• Baseline imaging assessment of the brain (MRI or CT scan) performed within 8 weeks prior to randomization must show no evidence of brain metastasis

• Complete surgical resection of the primary NSCLC is mandatory with negative surgical margins and systematic lymph node sampling or dissection.

• Complete recovery from surgery, including post-operative wound healing at the time of randomization. Randomization must occur between 4 weeks and 12 weeks following surgery.

• Eastern cooperative oncology group performance status (ECOG PS) of 0 or 1.

• Pathologic (post-operative) Stage IB, IIA, IIB, or IIIA according to the tumor nodes metastasis (TNM) staging system for lung cancer. In addition, participants with stage IIIB are eligible when regional lymph node involvement is N2.

• \- Participants with Stage IB NSCLC should be considered when disease has high-risk features (eg, visceral pleural invasion, lymphovascular invasion or high-grade histology) and participants are suitable for adjuvant chemotherapy according to international guidelines such as the 2025 European Society for Medical Oncology guideline.

• Archival tumor tissue available for submission, with minimum quantity sufficient to evaluate EGFRmt status and, where possible, other biomarkers.

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