An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa Lung 536)
Date de révision : 22/04/2026
18 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 03/06/2025
Critères :
Critères d'inclusion :
- Subject must have had no prior systemic therapy for locally advanced or metastatic NSCLC including PD-L1/PD-L2 inhibitor, CTLA-4 inhibitor, TIM 3 inhibitors, or any other immunotherapy Subject may have received prior adjuvant/neoadjuvant systemic therapy and/or radiation as defined in protocol (Allowed for 1L pts), in both parts.
- Subject must have received 1 line of prior systemic therapy in the locally advanced or metastatic setting (Neoadjuvant and adjuvant systemic therapy would count as a prior line). Eligibility for subjects with or without actionable gene alterations will be defined in protocol (Allowed for 2L pts), on part 1 only.
Critères d'exclusion :
- For 1L subjects in Part 1 and 2: Subjects with EGFR or other genomic aberration (e.g., ALK, ROS1, KRAS G12C, BRAFV600E, NTRK1,2,3, RET1, HER-2, MET exon 14 skipping, etc.) for which a locally approved targeted therapy is available for first-line treatment.
- Subject with prior treatment of a c-Met targeting antibody (e.g., ABBV-400, ABBV-399 or topoisomerase-inhibitor containing regimen. Prior treatment with MET tyrosine kinase inhibitors is allowed.
- 3. Subject with known uncontrolled metastases to the CNS.
Lieux et contacts
Informations pratiques pour participer à cet essai.
Sites des essais
Adresse
Centre Antoine Lacassagne
Nice Cedex 2 France
Institut Bergonie
33000 Bordeaux France
Centre Hospitalier Universitaire De Nantes
44800 Saint-Herblain 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".