Phase
Condition
Solid Tumors
Non-small Cell Lung Cancer
Treatment
ORIC-114 Dose 3 + amivantamab
ORIC-114 Dose 2 + amivantamab
ORIC-114 Dose 3 + amivanatamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically confirmed metastatic NSCLC with a documented EGFRexon 20 insertion mutation as determined locally by any nucleic acid-baseddiagnostic testing method; all tests should be performed in a CLIA certified orequivalently accredited laboratory
Prior Therapies:
Dose Escalation: Patients may have previously received and progressed on orafter platinum-based chemotherapy or may be treatment naïve
Dose Expansion: Patients must not have received any prior therapy; at time ofenrollment, patients must decline, or be ineligible for all available standardof care therapies with proven benefit
Agreement and ability to undergo a pretreatment biopsy, provided the procedure isclinically 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
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, radiationpneumonitis which required steroid treatment, or any evidence of clinically activeILD
Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or shortgut syndrome) or other malabsorption syndromes that would reasonably impactabsorption of ORIC-114
Study Design
Study Description
Connect with a study center
Peter MacCallum Cancer Centre
Melbourne, Victoria 03000
AustraliaSite Not Available
The Princess Margaret Hospital
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
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