A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy * Measurable disease, as defined by RECIST v1.1 * No prior systemic treatment for advanced or metastatic NSCLC * Documentation of the presence of a KRAS G12C mutation * Documentation of known PD-L1 expression status in tumor tissue * Availability of a representative tumor specimen * Adequate end-organ function * Eligible to receive a platinum-based chemotherapy regimen Exclusion Criteria Related to NSCLC: * Known concomitant second oncogenic driver with available targeted treatment * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for \>=2 weeks prior to randomization * History of leptomeningeal disease * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently) Exclusion Criteria Related to Current or Prior Treatments: * Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study * Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung \>30Gy within 6 months prior to randomization * Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors * Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors * Current treatment with medications that are well known to prolong the QT interval * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization * Prior allogeneic stem cell or solid organ transplantation Exclusion Criteria Related to General Health: * History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival \[OS\] rate \>90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer * Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan * Significant cardiovascular disease within 3 months prior to screening
Study sites (64)
AK
- Alaska Oncology and Hematology · Anchorage, AK 99508More trials in Anchorage
AZ
- City of Hope - Phoenix · Goodyear, AZ 85338More trials in Goodyear
CA
- Community Cancer Institute (CCI) · Clovis, CA 93611More trials in Clovis
- Marin Cancer Care Inc · Greenbrae, CA 94904More trials in Greenbrae
- UCI Health-CIACC · Irvine, CA 92612More trials in Irvine
- UCLA Oncology Center · Los Angeles, CA 90024More trials in Los Angeles
- Hoag Memorial Hospital · Newport Beach, CA 92658More trials in Newport Beach
- University of California Irvine · Orange, CA 92868More trials in Orange
- Palo Alto Medical Foundation Research Center · Palo Alto, CA 94301More trials in Palo Alto
- Sutter Institute for Medical Research · Roseville, CA 95661More trials in Roseville
- California Pacific Medical Center · San Francisco, CA 94115More trials in San Francisco
CO
- UC Health Oncology Research · Colorado Springs, CO 80909More trials in Colorado Springs
- Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System · Fort Collins, CO 80528More trials in Fort Collins
CT
- Hartford Hospital · Hartford, CT 06102-5037More trials in Hartford
FL
- Florida Cancer Specialists - SOUTH - SCRI - PPDS · Fort Myers, FL 33901-8108More trials in Fort Myers
- University of Florida Health at Shands · Gainesville, FL 32610More trials in Gainesville
- BioResearch Partner · Hialeah, FL 33013More trials in Hialeah
- Memorial Healthcare System - Memorial Regional Hospital · Hollywood, FL 33021More trials in Hollywood
- Sylvester Comprehensive Cancer Center · Miami, FL 33136More trials in Miami
- Advent Health Orlando · Orlando, FL 32804More trials in Orlando
- Ascension Sacred Heart · Pensacola, FL 32504More trials in Pensacola
- Florida Cancer Specialists - NORTH - SCRI - PPDS · St. Petersburg, FL 33701More trials in St. Petersburg
- Florida Cancer Specialists - EAST - SCRI - PPDS · West Palm Beach, FL 33401-3406More trials in West Palm Beach
GA
- Piedmont Cancer Institute, PC · Atlanta, GA 30318More trials in Atlanta
- City of Hope® Atlanta · Newnan, GA 30265More trials in Newnan
- Summit Cancer Care PC · Savannah, GA 31405More trials in Savannah
IA
- Mission Cancer + Blood - IMMC · Des Moines, IA 50309More trials in Des Moines
- University of Iowa · Iowa City, IA 52242More trials in Iowa City
ID
- St. Luke's Cancer Institute · Boise, ID 83712More trials in Boise
IL
- Affiliated Oncologists, LLC · Chicago Ridge, IL 60415More trials in Chicago Ridge
- Hope and Healing Cancer Services · Hinsdale, IL 60521More trials in Hinsdale
- City of Hope® Cancer Center Chicago · Zion, IL 60099More trials in Zion
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
- University of Massachusetts Memorial Medical Center · Worcester, MA 01655More trials in Worcester
MD
- Saint Agnes Hospital - Baltimore - Hunt - PPDS · Baltimore, MD 21229-5201More trials in Baltimore
- Walter Reed National Military Medical Center · Bethesda, MD 20889More trials in Bethesda
MI
- Profound Research, LLC · Farmington Hills, MI 48334More trials in Farmington Hills
MN
- Metro-Minnesota Community Oncology Research Consortium · Saint Louis Park, MN 55416More trials in Saint Louis Park
MO
- Missouri Baptist Medical Center · St Louis, MO 63131More trials in St Louis
NC
- Firsthealth of The Carolinas · Pinehurst, NC 28374More trials in Pinehurst
NE
- NHO Revive Research Institute · Lincoln, NE 68506More trials in Lincoln
NJ
- AsteraCancer Care · East Brunswick, NJ 08816More trials in East Brunswick
NM
- San Juan Oncology Associates · Farmington, NM 87401More trials in Farmington
NV
- Cancer Care Specialists · Reno, NV 89511More trials in Reno
NY
- SUNY Upstate Medical University · Syracuse, NY 13210More trials in Syracuse
- Montefiore Einstein Cancer Center · The Bronx, NY 10461More trials in The Bronx
- Clinical Research Alliance · Westbury, NY 11590More trials in Westbury
OH
- Ohio State University · Columbus, OH 43210More trials in Columbus
OR
- Oregon Health and Science University · Portland, OR 97239More trials in Portland
PA
- St. Luke's University Health Network · Bethlehem, PA 18015More trials in Bethlehem
- Allegheny Cancer Center · Pittsburgh, PA 15212More trials in Pittsburgh
- Reading Hospital - McGlinn Cancer Institute · West Reading, PA 19611More trials in West Reading
TN
- Baptist Cancer Center · Memphis, TN 38120More trials in Memphis
TX
- The University of Texas Southwestern Medical Center at Dallas · Dallas, TX 75390-8575More trials in Dallas
- Renovatio Clinical - El Paso · El Paso, TX 79915More trials in El Paso
- JPS Health Network · Fort Worth, TX 76104More trials in Fort Worth
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030-4000More trials in Houston
- Community Clinical Trials · Kingwood, TX 77339More trials in Kingwood
- Texas Tech Health Science Center · Lubbock, TX 79415More trials in Lubbock
- Renovatio Clinical · The Woodlands, TX 77380More trials in The Woodlands
- University of Texas Health Center at Tyler · Tyler, TX 75708More trials in Tyler
VA
- Virginia Oncology Associates · Norfolk, VA 23502More trials in Norfolk
WI
- Ascension Network - St Elizabeth's Hospital · Appleton, WI 54915More trials in Appleton
- Ascension Columbia St. Mary's · Milwaukee, WI 53211More trials in Milwaukee