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RecruitingLast updated: 16 February 2026

ORIC-114-05: A trial recruiting people with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation to test the safety and effect of a combination of targeted therapiesPhase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

ORIC-114-05

Clinical summary

Summary

This clinical trial is testing a new treatment combination for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific genetic change known as an EGFR exon 20 insertion mutation.

What are the treatments being studied?

  • ORIC-114 is a type of medicine taken by mouth. It’s designed to reach the brain and target the EGFR mutation directly, which may help treat cancer that has spread to the brain.
  • Amivantamab is an antibody treatment that targets two proteins (EGFR and MET) involved in cancer growth. It’s already used to treat this type of lung cancer, either alone or with chemotherapy.

The study has two parts. Part 1 will test three different dose levels of ORIC-114 when given in addition to amivantamab. ORIC-114 will be given orally daily, and amivantamab will be given as an injection weekly for 4 weeks, and then one injection every 4 weeks. To be eligible for Part 1, participants may have previously received and progressed on or after platinum-based chemotherapy, or they may be treatment naive.

Part 2 will further explore the safety and effect of two dose levels of ORIC-114 plus amivantamab. To be eligible for Part 2, participants must not have received any prior therapy.

Conditions

This trial is treating people with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation

Eligibility

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:

    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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

ORIC Pharmaceuticals

Scientific Title

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

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