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ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC
NCT06816992 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG ORIC-114 Dose 1 + amivantamab
- DRUG ORIC-114 Dose 2 + amivantamab
- DRUG ORIC-114 Dose 3 + amivantamab
Study Locations (4)
New York
- NYU Langone Health — New York
Virginia
- Virginia Cancer Specialists — Fairfax
Victoria
- Peter MacCallum Cancer Centre — Melbourne
Ontario
- The Princess Margaret Hospital — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06816992
The ClinicalTrials.gov registry entry for NCT06816992 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ORIC Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Solid Tumors appearing as the primary indexed condition, and to 3 interventions — of which ORIC-114 Dose 1 + amivantamab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06816992 reports 4 study locations spanning 4 distinct geographic areas — top geographies include New York, Virginia, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06816992 about?
NCT06816992 is a clinical study titled "ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC". 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 2...
What is the current status of trial NCT06816992?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2025-02-27. Estimated completion is 2027-05.
What conditions does trial NCT06816992 study?
This clinical trial studies the following conditions: Solid Tumors, NSCLC, EGFR Exon 20 Insertion Mutations, EGFR-mutated NSCLC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06816992?
The interventions under investigation include: ORIC-114 Dose 1 + amivantamab (DRUG), ORIC-114 Dose 2 + amivantamab (DRUG), ORIC-114 Dose 3 + amivantamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06816992?
This trial is sponsored by ORIC Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06816992 being conducted?
This trial has 4 study locations across New York, Virginia, Victoria, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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