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)
Date de révision : 12/05/2026
34 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 14/07/2025
Critères :
Critères d'inclusion :
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- 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.
Critères d'exclusion :
- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years prior to randomization..
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
- Inadequate bone marrow function.
- Inadequate liver function.
- 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.
- Certain significant ECG abnormalities.
- 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.
- Evidence of active infection requiring parenteral therapy in the 2 weeks prior to randomization.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
68100 Mulhouse France
Centre Hospitalier Regional De Marseille
13001 Marseille France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".