NCT06816992 · ORIC Pharmaceuticals
ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
What this study is about
The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, how the drug moves through the body (PK), how the drug affects the body (PD), and preliminary antitumor activity of ORIC-114 in combination with injected under the skin (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.
View original scientific description
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.
Interventions
DRUG
ORIC-114 Dose 1 + amivantamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
DRUG
ORIC-114 Dose 2 + amivantamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
DRUG
ORIC-114 Dose 3 + amivantamab
ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
Primary outcome measures
Recommended Phase 2 Dose (RP2D)
Time frame: 12 months
RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design
Objective response rate (ORR)
Time frame: 12 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Duration of response (DOR)
Time frame: 12 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Progression-free survival (PFS)
Time frame: 12 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
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
- New York, New York
- Fairfax, Virginia
Collaborators
Janssen Research and Development LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations