Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.

• Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologicallyconfirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1TPS < 50% AND previously completed 4 cycles of standard-of-care platinum basedinduction chemotherapy with pembrolizumab AND experienced stable disease, partialresponse, or complete response per investigator's assessment after 4 cycles OR ifpatients received <4 cycles of a platinum-based induction, was stopped early due tointolerable toxicity

• Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologicallyconfirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1TPS < 50%

• Presence of measurable disease per RECIST v1.1

Exclusion Criteria:

• All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting

• Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC,including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvantsetting are allowed if last dose of prior systemic treatment was >1 year prior tofirst dose of study treatment)

• Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexedfollowing completion of 4-6 cycles of a platinum-based regimen administered in thefirst-line setting

• Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment

• Active brain metastases