Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Interventional
Phase 3
Mirati Therapeutics Inc. (Voir sur ClinicalTrials)
avril 2025
avril 2032
25 juillet 2025
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus
pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus
platinum-doublet chemotherapy in participants with previously untreated, locally advanced
or metastatic NSCLC with KRAS G12C mutation
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Marie Wislez, Site 0158 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Fabrice Barlesi, Site 0213 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - 14076 - Caen - Calvados - France | Hubert CURCIO, Site 0296 | Contact (sur clinicalTrials) | |||
| Centre Georges François Leclerc - 21079 - Dijon - Côte-d'Or - France | Coureche Kaderbhai, Site 0605 | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois - 54511 - Vandoeuvre lès Nancy - Meurthe-et-Moselle - France | Bertrand Mennecier, Site 0589 | Contact (sur clinicalTrials) | |||
| CHRU de Brest - 29609 - Brest - Finistère - France | Margaux Geier, Site 0512 | Contact (sur clinicalTrials) | |||
| Chu Gabriel Montpied - 63000 - Clermont-Ferrand - France | Patrick MERLE, Site 0134 | Contact (sur clinicalTrials) | |||
| Chu Grenoble Alpes - 38700 - La Tronche - Isère - France | Denis Moro-Sibilot, Site 0220 | Contact (sur clinicalTrials) | |||
| Hôpital Ambroise Paré - 92100 - Boulogne-Billancourt - France | Etienne Giroux-Leprieur, Site 0513 | Contact (sur clinicalTrials) | |||
| Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes - 44800 - Saint-Herblain - France | Elvire Pons-Tostivint, Site 0139 | Contact (sur clinicalTrials) | |||
| Institut Régional du Cancer Montpellier - 34298 - Montpellier - Hérault - France | Xavier Quantin, Site 0558 | Contact (sur clinicalTrials) | |||
| Local Institution - 0133 - 75248 - Paris - France | Site 0133 | Contact (sur clinicalTrials) | |||
| Local Institution - 0159 - 68100 - Mulhouse - Alsace - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0164 - 13915 - Marseille - France | Site 0164 | Contact (sur clinicalTrials) | |||
| Local Institution - 0552 - 80054 - Amiens - Somme - France | Site 0552 | Contact (sur clinicalTrials) | |||
| Local Institution - 0560 - 49933 - Angers - Maine-et-Loire - France | Site 0560 | Contact (sur clinicalTrials) | |||
| Local Institution - 0604 - 87042 - Limoges - France | Site 0604 | Contact (sur clinicalTrials) | |||
| Local Institution - 0636 - 13273 - Marseille - Provence-Alpes-Côte-d'Azur - France | Site 0636 | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with
evidence of KRAS G12C mutation via tumor tissue and/or circulating tumor
deoxyribonucleic acid (ctDNA).
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI)
per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical
resection).
- Participants with brain metastases are eligible for enrollment, including those with
untreated brain metastases. Brain metastases must be asymptomatic and not in need of
immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay,
Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with
evidence of KRAS G12C mutation via tumor tissue and/or circulating tumor
deoxyribonucleic acid (ctDNA).
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI)
per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical
resection).
- Participants with brain metastases are eligible for enrollment, including those with
untreated brain metastases. Brain metastases must be asymptomatic and not in need of
immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay,
Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
- Participants with an active, known, prior documented, or suspected autoimmune or
inflammatory disease.
- Uncontrolled or significant cardiovascular conditions within 6 months prior to
enrollment.
- Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
- Ongoing treatment with concomitant medication known to cause prolonged QTc interval
and that cannot be switched to alternative treatment prior to study entry.
- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration.
- Other protocol-defined Inclusion/Exclusion criteria apply.