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

NCT06816992 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-24

No results posted yet for this 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

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

Sponsors & Collaborators

  • Janssen Research and Development LLC

    collaborator UNKNOWN

  • ORIC Pharmaceuticals

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816992 on ClinicalTrials.gov