Clinical Trials

Inclusion Criteria:

- Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with
KRAS G12C mutation and any PD-L1 TPS

- Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or
nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%

- Phase 3: Presence of evaluable or measurable disease per RECIST

- Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of
the following:

1. No evidence of brain metastases

2. Untreated brain metastases not needing immediate local therapy

3. Previously treated brain metastases not needing immediate local therapy

Exclusion Criteria:

- Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC
including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting
KRAS G12C mutation (e.g., AMG 510).

- Phase 2: Active brain metastases

- Phase 3: Patients with known central nervous system (CNS) lesions must not have any of
the following:

1. Any untreated brain lesions > 1.0 cm in size

2. Any brainstem lesions

3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions
at a total daily dose of > 10 mg of prednisone (or equivalent) prior to
randomization.

4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or
manifest neurologic progression due to brain lesions notwithstanding CNS-directed
therapy

- Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of
study treatment

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/3/1/23. Questions regarding updates should be directed to the study team contact.