A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Olomorasib Combination Therapy in Metastatic Non-small Cell Lung Cancer
Summary
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose \[RP2CD\]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents the growth of tumors in participants with KRAS G12C mutant metastatic non-small cell lung cancer (NSCLC: the most common type of lung cancer; metastatic: has spread to other parts of the body; KRAS G12C mutant: mutation \[change\] in the kirsten rat sarcoma viral oncogene homolog \[KRAS\] gene in tumor cells in which glycine \[G\] at position 12 is replaced with cystine \[C\]).
Arms & interventions
- DrugAmivantamab
Amivantamab will be administered.
- DrugOlomorasib
Olomorasib will be administered.
Outcome measures
Primary
Phase 1: Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade will be made by the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 defined as follows: Grade 1 (mild; asymptomatic or mild symptoms; intervention not indicated); Grade 2 (moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 (life-threatening consequences; urgent intervention indicated); Grade 5 (Death related to adverse event).
Time frame: Up to approximately 3 years 2 months
Phase 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
DLT is defined as drug related adverse events and includes unacceptable non-hematologic toxicity, hematologic toxicity, pulmonary toxicity, or elevations in hepatic enzymes suggestive of drug-induced liver injury of Grade 3 or higher. Toxicities will be graded for severity according to the NCI-CTCAE, version 5.0.
Time frame: Up to approximately 3 years 2 months
Phase 2: Confirmed Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve either a confirmed partial response (PR) or complete response (CR), using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 by investigator review. Confirmatory analysis may be performed using Blinded Independent Central Review (BICR).
Time frame: Up to approximately 3 years 2 months
Secondary
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to approximately 3 years 2 months
Number of Participants with Abnormalities in Clinical Laboratory Parameters
Time frame: Up to approximately 3 years 2 months
Phase 2: Duration of Response (DoR)
Time frame: Up to approximately 3 years 2 months
Phase 2: Disease Control Rate (DCR)
Time frame: Up to approximately 3 years 2 months
Phase 2: Progression-Free Survival (PFS)
Time frame: Up to approximately 3 years 2 months
Phase 2: Overall Survival (OS)
Time frame: Up to approximately 3 years 2 months
Eligibility criteria
Study locations (6)
University of California Irvine
Irvine, California, 92697
New York University Langone Medical Center
New York, New York, 10016
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Oncology Consultants Cancer Center
Houston, Texas, 77030
Virginia Cancer Specialists
Fairfax, Virginia, 22031
NorthWest Medical Specialties, PLLC
Puyallup, Washington, 98373