ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
Recruiting now · Phase 1
Conditions studied: Solid Tumors, EGFR Exon 20 Insertion Mutations, NSCLC, EGFR-mutated NSCLC
In brief
The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.
Key facts
- Study ID
- NCT06816992
- Run by
- ORIC Pharmaceuticals
- People needed
- 76
- Starts
- 2025-02-27
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 chemotherapy 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 biopsy, 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 Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
You may not qualify if…
- 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, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
- Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114
Where it is running
- NYU Langone Health — New York, New York, United States (enrolling)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- The Princess Margaret Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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