ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic NSCLC with a documented EGFRexon 20 insertion mutation as determined locally by any nucleic acid-baseddiagnostic testing method; all tests should be performed in a CLIA certified orequivalently accredited laboratory

• Prior Therapies:

1. Dose Escalation: Patients may have previously received and progressed on orafter platinum-based chemotherapy or may be treatment naïve

2. Dose Expansion: Patients must not have received any prior therapy; at time ofenrollment, patients must decline, or be ineligible for all available standardof care therapies with proven benefit

• Agreement and ability to undergo a pretreatment biopsy, provided the procedure isclinically feasible and not deemed unsafe by the investigator

• Measurable disease according to RECIST 1.1

• Patients with asymptomatic CNS metastases are eligible

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ function

Exclusion Criteria:

• Known small cell lung cancer transformation

• Leptomeningeal disease

• Spinal cord compression not definitively treated with surgery or radiation

• Prior immunotherapy

• Past medical history of interstitial lung disease (ILD), drug induced ILD, radiationpneumonitis which required steroid treatment, or any evidence of clinically activeILD

• Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or shortgut syndrome) or other malabsorption syndromes that would reasonably impactabsorption of ORIC-114