NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial

Inclusion Criteria:

Patients with stage IV non-squamous non-small-cell lung cancer (NSCLC) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following:

Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age ≥ 18 years old on the day of signing informed consent.
Estimated life expectancy > 3 months.
At least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.

Exclusion Criteria:

Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.