Brief Summary
The purpose of this study is to establish the recommended phase 2 dosethe amount of medication taken (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneousunder the skin (SC) amivantamab in patients with advancedat a late stage, far along or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.
Intervention / Treatment
- Drug: ORIC-114 Dose 1 + amivantamab
- Drug: ORIC-114 Dose 2 + amivantamab
- Drug: ORIC-114 Dose 3 + amivantamab
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory
- Prior Therapies:
- Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells or may be treatment naïve
- Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit
- Agreement and ability to undergo a pretreatment biopsyremoval of a section of tissue to analyse for cancer cells, provided the procedure is clinically feasible and not deemed unsafe by the investigator
- Measurable disease according to RECIST 1.1
- Patients with asymptomatic CNS metastases are eligible
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Adequate organ function