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Study of ORIC-114 with Amivantamab for EGFR Exon 20 Insertion NSCLC

This study is testing a new combination treatment for advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific change called an EGFR exon 20 insertion mutation. The treatment involves two drugs: ORIC-114, taken by mouth daily, and amivantamab, given as an injection under the skin. Researchers want to find the best dose of ORIC-114 when given with amivantamab, understand how safe the combination is, and see if it can shrink tumors. You would need to have this specific EGFR mutation to join. The study will look at how many people respond to the treatment and for how long. There are 76 people planned to join this study.

Study design
This is an open-label, single-arm study, meaning everyone receives the treatment and you and your doctors will know which treatment you are getting. It involves a dose escalation phase to find the best dose, followed by a dose expansion phase. There are 76 participants planned for this study.
What's involved
ORIC-114 is taken by mouth daily. Amivantamab is given as a subcutaneous (under the skin) injection weekly for 4 weeks, then every 4 weeks after that.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works and how long responses last for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06816992

ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC

Recruiting
PHASE1Ages 18+InterventionalTreatment
ORIC Pharmaceuticals
~76 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:ORIC-114 Dose 1 + amivantamabORIC-114 Dose 2 + amivantamabORIC-114 Dose 3 + amivantamab

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (RP2D)
Measured over 12 months
+3 more outcomes measured

Conditions

Solid Tumors
EGFR Exon 20 Insertion Mutations
NSCLC
EGFR-mutated NSCLC

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Where it's being run

4 sites across 4 states
New York1
Virginia1
Victoria1
Ontario1

Study leadership

  • Pratik S. Multani, MD, MS · STUDY_DIRECTOR · ORIC Pharmaceuticals

Who to contact

ORIC Clinical
[email protected]
650-388-5600
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Recommended Phase 2 Dose (RP2D)12 months

    RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design

  • Objective response rate (ORR)12 months

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Duration of response (DOR)12 months

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Progression-free survival (PFS)12 months

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1