RECRUITING

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

Conditions

Solid Tumors EGFR Exon 20 Insertion Mutations NSCLC EGFR-mutated NSCLC EGFR mutations EGFR exon20 ORIC-114 Amivantamab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06816992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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 Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

ORIC Clinical

CONTACT

650-388-5600

clinical@oricpharma.com

Principal Investigator

Pratik S. Multani, MD, MS

STUDY_DIRECTOR

ORIC Pharmaceuticals

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

NYU Langone Health

New York, New York, 10016

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: ORIC Pharmaceuticals

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2027-05

Study Record Updates

Study Start Date2025-02

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

NSCLC
EGFR mutations
EGFR exon20
EGFR exon 20 insertion mutations
ORIC-114
Amivantamab

Additional Relevant MeSH Terms

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