Combining ORIC-114 with Amivantamab for NSCLC with EGFR Exon 20 Insertion Mutations
Phase 1b Study of ORIC-114 in Combination With Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
This study is testing a new combination of two drugs, ORIC-114 and amivantamab, to see if they can help people with advanced lung cancer that has a specific genetic mutation.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ORIC Pharmaceuticals Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, amivantamab |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT06816992 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the recommended phase 2 dose, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORIC-114 when used in combination with subcutaneous amivantamab in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has an EGFR exon 20 insertion mutation. The study is open-label and single-arm, involving a dose escalation followed by dose expansion to assess the effectiveness of this combination therapy. ORIC-114 is a selective small molecule inhibitor designed to target specific mutations, while amivantamab is an antibody that targets EGFR and MET receptors, providing a dual approach to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically or cytologically confirmed metastatic NSCLC harboring an EGFR exon 20 insertion mutation.
Not a fit: Patients who have received prior therapies for their NSCLC or those with other types of EGFR mutations may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could offer a new treatment option for patients with a specific type of NSCLC that is currently difficult to treat.
How similar studies have performed: Other studies have shown promise in targeting EGFR mutations in NSCLC, but the specific combination of ORIC-114 and amivantamab is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve 2. 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 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, 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 this trial is running
New York, New York and 3 other locations
- NYU Langone Health — New York, New York, United States (Recruiting)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Not_yet_recruiting)
- The Princess Margaret Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: ORIC Clinical
- Email: clinical@oricpharma.com
- Phone: 650-388-5600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.