Combining ORIC-114 with Amivantamab for NSCLC with EGFR Exon 20 Insertion Mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine the recommended phase 2 dose, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORIC-114 when used in combination with subcutaneous amivantamab in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has an EGFR exon 20 insertion mutation. The study is open-label and single-arm, involving a dose escalation followed by dose expansion to assess the effectiveness of this combination therapy. ORIC-114 is a selective small molecule inhibitor designed to target specific mutations, while amivantamab is an antibody that targets EGFR and MET receptors, providing a dual approach to treatment.

Why it matters

Who can join: the full rules

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:

  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 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 it's running

• NYU Langone Health
  New York, New York, United States Recruiting
• Virginia Cancer Specialists
  Fairfax, Virginia, United States Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Not yet recruiting
• The Princess Margaret Hospital
  Toronto, Ontario, Canada Not yet recruiting

Study contacts

• Study coordinator: ORIC Clinical
• Email: clinical@oricpharma.com
• Phone: 650-388-5600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.