Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Launched by MIRATI THERAPEUTICS INC. · May 2, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The KRYSTAL 21 trial is studying a medication called adagrasib, which is being tested in two different doses to see which one works better for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change known as the KRAS G12C mutation. The trial aims to find out whether taking 600 mg of adagrasib twice a day is more effective than taking 400 mg twice a day. This study is currently looking for participants, and anyone aged 18 or older who has advanced NSCLC and has previously received certain treatments may be eligible to join.
To qualify for the trial, participants must have already been treated with chemotherapy and an immune checkpoint inhibitor and must be in recovery, with their blood tests showing safe levels. However, individuals who have been treated with other KRAS G12C-targeted drugs or have certain medical conditions that could complicate their treatment are not eligible. If you join the trial, you can expect regular check-ups and monitoring to see how well the medication is working for you. This trial offers an opportunity to contribute to research that could help improve treatments for lung cancer.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
- • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
- • Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
- • Have recovered from their prior treatment and blood tests are within a safe range.
- Key Exclusion Criteria:
- • Have had previous treatment with a drug that targets KRAS G12C.
- • Have cancer that can potentially be removed with surgery.
- • Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
- • Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
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
Bangkok, , Thailand
Valencia, , Spain
Seoul, , Korea, Republic Of
Durham, North Carolina, United States
Haifa, , Israel
Barcelona, , Spain
Madrid, , Spain
Kansas City, Missouri, United States
Madrid, , Spain
Barcelona, , Spain
Quimper, , France
Porto Alegre, Rio Grande Do Sul, Brazil
Seoul, , Korea, Republic Of
Santiago De Compostela, A Coruña, Spain
Seoul, , Korea, Republic Of
Sevilla, , Spain
Sibiu, , Romania
Goyang Si, , Korea, Republic Of
Iasi, , Romania
Malaga, , Spain
Haifa, , Israel
Oviedo, Asturias, Spain
Goyang Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Craiova, Dolj, Romania
Ankara, , Turkey
Marseille, , France
Candiolo, Torino, Italy
Nieuwegein, Utrecht, Netherlands
Marseille, , France
Athens, Attiki, Greece
Jerusalem, Yerushalayim, Israel
Poitiers, Poitou Charentes, France
Palma De Mallorca, Baleares, Spain
Itajaí, Santa Catarina, Brazil
Madrid, , Spain
Kansas City, Missouri, United States
Novara, , Italy
Ankara, , Turkey
Patra, , Greece
Ankara, , Turkey
Santa Rosa, California, United States
Marseille, , France
Goyang Si, Gyeonggido [Kyonggi Do], Korea, Republic Of
Krakow, , Poland
Milano, , Italy
Lublin, , Poland
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Edirne, , Turkey
Istanbul, , Turkey
Taichung City, Taichung, Taiwan
Timisoara, Timis, Romania
Gdynia, Pomorskie, Poland
Dallas, Texas, United States
Taichung City, , Taiwan
Istanbul, , Turkey
Lorient, , France
Pessac, , France
Sevilla, , Spain
Paris, Saint Mandé, France
Seoul, , Korea, Republic Of
Santiago De Compostela, Calle Choupana, Spain
Cluj Napoca, Cluj, Romania
Craiova, Dolj, Romania
Barcelona, , Spain
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Durham, North Carolina, United States
Cachoeiro Do Itapemirim, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Itajaí, Santa Catarina, Brazil
Salvador, , Brazil
São Paulo, , Brazil
Zagreb, Grad Zagreb, Croatia
Pula, , Croatia
Pessac, Gironde, France
Saint Herblain Cedex, Loire Atlantique, France
Angers, Maine Et Loire, France
Poitiers, Poitou Charentes, France
Grenoble, Rhône Alpes, France
Villefranche Sur Saone, Rhône, France
Lorient, , France
Nantes Cedex 1, , France
Quimper, , France
Saint Mandé, , France
Patras, Achaïa, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Haidari Athens, Attiki, Greece
Thessaloniki, Kentriki Makedonia, Greece
Panorama, , Greece
Thessaloniki, , Greece
Tel Aviv Yafo, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Haifa, , Israel
Haifa, , Israel
Tel Aviv, , Israel
Pesaro, Pesaro E Urbino, Italy
Candiolo, Torino, Italy
Milano, , Italy
Novara, , Italy
Perugia, , Italy
Roma, , Italy
Gyeonggido [Kyonggi Do], Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Seoul, Seoul Teugbyeolsi [Seoul T'ukpyolshi], Korea, Republic Of
Seoul Teugbyeolsi [Seoul T'ukpyolshi], , Korea, Republic Of
Tuxtla Gutiérrez, Chiapas, Mexico
Cdmx, Distrito Federal, Mexico
Col. Roma, Distrito Federal, Mexico
Toluca, , Mexico
Breda, Noord Brabant, Netherlands
Amsterdam, Noord Holland, Netherlands
Nieuwegein, Utrecht, Netherlands
Krakow, Malopolskie, Poland
Gdynia, Pomorskie, Poland
Lublin, , Poland
Cluj Napoca, Cluj, Romania
Ovidiu, Constanta, Romania
Craiova, Dolj, Romania
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Iasi, , Romania
Sibiu, , Romania
Suceava, , Romania
Belgrade, Beograd, Serbia
Nis, Niaavski Okrug, Serbia
Kragujevac, šumadijski Okrug, Serbia
Malaga, Andalucía, Spain
Oviedo, Asturias, Spain
Palma De Mallorca, Baleares, Spain
Valencia, Valenciana, Comunidad, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Valencia, , Spain
Kaohsuing City, Kaohsiung, Taiwan
Taichung City, Taichung Municipality, Taiwan
Taichung City, Taichung, Taiwan
Taichung City, Taichung, Taiwan
Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Songkhla, , Thailand
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Edirne, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Angers, Maine Et Loire, France
Nantes Cedex 1, , France
Seoul Teugbyeolsi [Seoul T'ukpyolshi], , Korea, Republic Of
Kaohsuing City, Kaohsiung, Taiwan
Ankara, , Turkey
Barcelona, , Spain
Thessaloniki, , Greece
Itajaí, Santa Catarina, Brazil
Istanbul, , Turkey
Craiova, Dolj, Romania
Barcelona, , Spain
Cachoeiro Do Itapemirim, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Salvador, , Brazil
São Paulo, , Brazil
Zagreb, Grad Zagreb, Croatia
Saint Herblain Cedex, Loire Atlantique, France
Grenoble, Rhône Alpes, France
Villefranche Sur Saone, Rhône, France
Patras, Achaïa, Greece
Haidari Athens, Attiki, Greece
Thessaloniki, Kentriki Makedonia, Greece
Panorama, , Greece
Tel Aviv Yafo, Tel Aviv, Israel
Tel Aviv, , Israel
Pesaro, Pesaro E Urbino, Italy
Perugia, , Italy
Roma, , Italy
Amsterdam, Noord Holland, Netherlands
Ovidiu, Constanta, Romania
Suceava, , Romania
Malaga, Andalucía, Spain
Palma De Mallorca, Baleares, Spain
Barcelona, , Spain
Khon Kaen, , Thailand
Istanbul, , Turkey
Izmir, , Turkey
Craiova, Dolj, Romania
Timisoara, Timis, Romania
Ankara, , Turkey
Toon, Ehime, Japan
San Martin De Porres, Lima, Peru
Craiova, Dolj, Romania
Nis, Vojvodina, Serbia
Barcelona, , Spain
Madrid, , Spain
Istanbul, Samsun, Turkey
Ankara, , Turkey
Utrecht, , Netherlands
Cluj Napoca, Cluj, Romania
Kragujevac, šumadijski Okrug, Serbia
Santa Rosa, California, United States
Chicago, Illinois, United States
Durham, North Carolina, United States
Belo Horizonte, São Paulo, Brazil
Pula, Istarska županija, Croatia
Saint Herblain Cedex, Loire Atlantique, France
Poitiers, Poitou Charentes, France
Marseille, Rhône, France
Patra, Achaïa, Greece
Thessaloniki, , Greece
Szolnok, Jász Nagykun Szolnok, Hungary
Haifa, Tel Aviv, Israel
Jerusalem, Yerushalayim, Israel
Tel Aviv, , Israel
Novara, Piemonte, Italy
Roma, , Italy
Nishinomiya, Hyôgo [Hyogo], Japan
Seoul, Seoul Teugbyeolsi [Seoul T'ukp, Korea, Republic Of
Tuxtla Gutiérrez, Chiapas, Mexico
Krakow, Malopolskie, Poland
Gdynia, Pomorskie, Poland
Suceava, , Romania
Nis, Vojvodina, Serbia
Sremska Kamenica, Vojvodina, Serbia
Belgrade, , Serbia
Belgrade, , Serbia
Santiago De Compostela, A Coruña, Spain
Santander, Cantabria, Spain
Madrid, , Spain
Sevilla, , Spain
Valencia, , Spain
Kaohsiung City, Kaohsiung, Taiwan
Taichung City, Taichung, Taiwan
Taipei City, Taipei, Taiwan
Muang, Chiang Mai, Thailand
Bangkok, Krung Thep Maha Nakhon [Bangkok], Thailand
Ankara, , Turkey
Ankara, , Turkey
Izmir, , Turkey
Belo Horizonte, , Brazil
Grenoble, , France
Villefranche Sur Saone, , France
Szolnok, , Hungary
Nishinomiya, , Japan
Seoul, , Korea, Republic Of
Kragujevac, , Serbia
Santiago De Compostela, , Spain
Valencia, , Spain
Col. Roma, Distrito Federal, Mexico
Songkhla, , Thailand
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported