Available in Argentina
The study has been designed as a Phase III trial and consists of 2 parts:
- Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in
comparison with docetaxel. Participants randomized to docetaxel arm will have the
opportunity to cross-over to JDQ443 at disease progression per RECIST 1.1 confirmed
by BIRC.
- Extension part will be open after final progression-free survival (PFS) analysis (if
the primary endpoint has met statistical significance) to allow participants
randomized to docetaxel treatment to crossover to receive JDQ443 treatment
regardless of progression on docetaxel.
The study population will include adult participants with locally advanced or metastatic
(stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma
as determined by a Novartis-designated central laboratory or accepted local tests) who
have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor
therapy administered either in sequence or as combination therapy.
Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio
stratified by prior line of therapy and ECOG performance status.
4Research sites
95Patients around the world