Informations générales (source: ClinicalTrials.gov)
A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
Interventional
Phase 2
Mirati Therapeutics Inc. (Voir sur ClinicalTrials)
février 2024
juillet 2026
10 mai 2025
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID
versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| APHM Hopital Nord - 13915 - Marseille - France | PASCALE TOMASINI, Site 551 | Contact (sur clinicalTrials) | |||
| Centre Hôspitalier de Bretagne Sud - Hôpital du Scorff - 56322 - Lorient - France | Regine Lamy, Site 552 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Cornouaille - 29000 - Quimper - France | Romain Corre, Site 558 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire D' Angers Hôpital Larrey - PNEUMOLOGIE - 49933 - Angers - Maine-et-Loire - France | Youssef Oulkhouir, Site 554 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Poitiers - 86000 - Poitiers - Poitou-Charentes - France | Nicolas Isambert, Site 557 | Contact (sur clinicalTrials) | |||
| Centre Hosptalier De Villefranche-Sur-Saone - Oncologie Medicale - Cancerolo - 69655 - Villefranche Sur Saone - Rhône - France | LIONEL FALCHERO, Site 560 | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - 0 - Grenoble - Rhône-Alpes - France | Denis Moro-Sibilot, Site 559 | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hôpital Nord Laënnec (HGRL) - 44093 - Nantes cedex 1 - France | Elvire Pons-Tostivint, Site 555 | Contact (sur clinicalTrials) | |||
| Hôpital Bégin - Service d'Oncologie - 94163 - Saint-Mandé - France | Carole Helissey, Site 550 | Contact (sur clinicalTrials) | |||
| Hopital Haut-Leveque - Maladies respiratoires - 33604 - Pessac - Gironde - France | Remi Veillon, Site 556 | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de I'Ouest - Service d'Oncologie Medicale - 44800 - Saint-Herblain Cedex - Loire-Atlantique - France | Sandrine Hiret, Site 553 | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.