Actively Recruiting
ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
Led by ORIC Pharmaceuticals · Updated on 2026-04-24
76
Participants Needed
4
Research Sites
143 weeks
Total Duration
On this page
Sponsors
O
ORIC Pharmaceuticals
Lead Sponsor
J
Janssen Research and Development LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic NSCLC with documented EGFR exon 20 insertion mutation by nucleic acid-based testing in accredited labs
- For dose escalation: prior progression on or after platinum-based chemotherapy or treatment-na�ve
- For dose expansion: no prior therapy; must decline or be ineligible for standard therapies with proven benefit
- Agreement and ability to undergo pretreatment biopsy if safe
- Measurable disease per RECIST 1.1
- Patients with asymptomatic CNS metastases eligible
- ECOG performance status 0 or 1
- Adequate organ function
You will not qualify if you...
- Known small cell lung cancer transformation
- Leptomeningeal disease
- Untreated spinal cord compression
- Prior immunotherapy
- History of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids, or clinically active ILD
- Active gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) or malabsorption syndromes affecting ORIC-114 absorption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
3
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 03000
Not Yet Recruiting
4
The Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 1Z5
Not Yet Recruiting
Research Team
O
ORIC Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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