Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
Launched by MIRATI THERAPEUTICS INC. · Nov 1, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called CA239-0010, is exploring a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) who have a specific genetic mutation known as KRAS G12C. The study is looking at how effective a combination of a drug called adagrasib, along with pembrolizumab (an immunotherapy) and chemotherapy, can be in treating these patients when they are starting treatment for the first time. The trial is currently recruiting participants of all genders, aged between 65 and 74, who have not received prior treatment for their cancer.
To be eligible for this trial, patients must have advanced or metastatic non-small cell lung cancer with a confirmed KRAS G12C mutation and a certain level of a protein called PD-L1, which helps the immune system fight cancer. Participants can expect to receive the combination therapy while being closely monitored by the research team. It's important to note that individuals who have previously undergone specific treatments for this type of cancer may not qualify for the trial. This study aims to find out if this combination therapy can help improve treatment outcomes for patients with this challenging condition.
Gender
ALL
Eligibility criteria
- • Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.
- • Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received \<4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
- • Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50%
- • Presence of measurable disease per RECIST v1.1
- Exclusion Criteria:
- • All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
- • Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
- • Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
- • Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
- • Active brain metastases
About Mirati Therapeutics Inc.
Mirati Therapeutics, Inc. is a biopharmaceutical company dedicated to discovering and developing transformative therapies for patients with genetically defined cancers. With a strong focus on precision medicine, Mirati leverages advanced science and innovative technologies to identify and target specific genetic mutations driving cancer progression. The company’s robust pipeline includes novel small molecules and immunotherapies, aimed at addressing significant unmet medical needs and improving patient outcomes. Committed to advancing oncology research, Mirati collaborates with healthcare professionals and research institutions to bring cutting-edge treatments from the lab to the clinic.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Chicago, Illinois, United States
Jacksonville, Florida, United States
Boston, Massachusetts, United States
Madrid, , Spain
Madrid, , Spain
Zaragoza, , Spain
Boston, Massachusetts, United States
Saint Louis Park, Minnesota, United States
Cleveland, Ohio, United States
Milan, , Italy
Paris, , France
Palma De Mallorca, , Spain
Caen Cedex 5, , France
Marseille, , France
Jacksonville, Florida, United States
Rochester, Minnesota, United States
Madrid, , Spain
A Coruña, , Spain
Paris, , France
Villejuif, , France
Sevilla, , Spain
Suresnes, , France
Toulouse Cedex 9, , France
Creteil, , France
Larissa, , Greece
Budapest, , Hungary
Sevilla, , Spain
Dallas, Texas, United States
San Francisco, California, United States
A Coruna, , Spain
Cleveland, Ohio, United States
Dijon Cedex, , France
Roma, , Italy
Casale Monferrato, Alessandria, Italy
Sevilla, Andalucia, Spain
Bellingham, Washington, United States
Novi, Michigan, United States
Majadahonda, Madrid, Spain
Budapest, , Hungary
Majadahonda, , Spain
Palma De Mallorca, , Spain
Palma De Mallorca, , Spain
Villejuif, , France
Larissa, Thessaly, Greece
Firenze, , Italy
Budapest, , Hungary
Rome, , Italy
Orbassano, , Italy
Fairfax, Virginia, United States
Ravenna, , Italy
Detroit, Michigan, United States
Firenze, Florence, Italy
Saint Louis Park, Minnesota, United States
Port Jefferson Station, New York, United States
La Tronche, , France
Heraklion, Crete, Greece
Fairfax, Virginia, United States
Palma De Mallorca, Balearic Islands, Spain
Heraklion, , Greece
East Syracuse, New York, United States
California City, California, United States
Székesfehérvár, , Hungary
Fountain Valley, California, United States
Lakeland, Florida, United States
Westwood, Kansas, United States
Szekesfehervar, , Hungary
Suresnes, île De France, France
Fountain Valley, California, United States
Denver, Colorado, United States
Austin, Texas, United States
Madrid, , Spain
łódź, , Poland
Angers, , France
La Tronche, Rhone, France
Piraeus, Attica, Greece
Torokbalint, , Hungary
Toulouse Cedex 9, Midi Pyrenees, France
Fullerton, California, United States
Poznań, , Poland
Dallas, Texas, United States
Caen Cedex 05, Basse Normadie, France
Dijon Cedex, Bourgogne, France
Créteil, Ile De France, France
Budapest, , Hungary
Avellino, , Italy
Roma, , Italy
Torokbalint, , Hungary
Warsaw, , Poland
Detroit, Michigan, United States
Lone Tree, Colorado, United States
Peiraias, , Greece
Lodz, , Poland
Anchorage, Alaska, United States
Glendale, Arizona, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Lakeland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Westwood, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Osage Beach, Missouri, United States
Springfield, Missouri, United States
Bronx, New York, United States
East Syracuse, New York, United States
Port Jefferson Station, New York, United States
Kettering, Ohio, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Longview, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Huntington, West Virginia, United States
Natal, Rio Grande Do Norte, Brazil
Ijui, Rio Grande Do Sul, Brazil
Itajai, Santa Catarina, Brazil
Barretos, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Jau, , Brazil
Rio De Janeiro, , Brazil
Sao Paolo, , Brazil
Vina Del Mar, Valparaiso, Chile
Providencia, , Chile
Santiago, , Chile
Temuco, , Chile
Angers Cedex 02, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Paris Cedex 05, , France
Paris, , France
Saint Herblain, , France
Batumi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Aviano, , Italy
Casale Monferrato, , Italy
Milan, , Italy
Padova, , Italy
Roma, , Italy
Kota Bharu, Kelantan, Malaysia
Kuantan, Pahang, Malaysia
Kuala Lumpur, , Malaysia
Putrajaya, , Malaysia
Konin, , Poland
Poznan, , Poland
Belgrade, , Serbia
Belgrade, , Serbia
Beograd, , Serbia
Kragujevac, , Serbia
Sremska Kamenica, , Serbia
Malaga, , Spain
Geneve, , Switzerland
Bang Phlat, , Thailand
Bangkok, , Thailand
Chom Thong, , Thailand
Khon Kaen, , Thailand
Fountain Valley, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Pueblo, Colorado, United States
Thornton, Colorado, United States
Fairway, Kansas, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Minneapolis, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Louis Park, Minnesota, United States
Kansas City, Missouri, United States
Kansas City, Missouri, United States
Lee's Summit, Missouri, United States
North Kansas City, Missouri, United States
Babylon, New York, United States
Bronx, New York, United States
Brooklyn, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Patchogue, New York, United States
Port Jefferson Station, New York, United States
Port Jefferson, New York, United States
Riverhead, New York, United States
Palestine, Texas, United States
Paris, Texas, United States
Tyler, Texas, United States
Arlington, Virginia, United States
Gainesville, Virginia, United States
Reston, Virginia, United States
Faenza, Ravenna, Italy
Lugo, Ravenna, Italy
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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