Titre |
A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer |
Protocole ID |
KontRASt-02 |
ClinicalTrials.gov ID |
NCT05132075 |
Type(s) de cancer |
Poumon non à petites cellules |
Phase |
Phase III |
Stade |
Maladie avancée ou métastatique |
Type étude |
Clinique |
Médicament |
JDQ443 versus docétaxel |
Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
Ville |
Sherbrooke |
Investigateur(trice) principal(e) |
Dre Nicole Bouchard
|
Coordonnateur(trice) |
Anick Champoux
819-346-1110 poste 12811
|
Statut |
Actif en recrutement |
Critètes d'éligibilité |
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- Participant has a KRAS G12C mutation present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
|
Critètes d'exclusion |
- Participant has previously received docetaxel, KRAS G12C inhibitor or any other systemic therapy for their locally advanced or metastatic NSCLC other than one platinum-based chemotherapy and one prior immune check point inhibitor
- Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
- Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Participant has an history of interstitial lung disease or pneumonitis grade > 1.
Other inclusion/exclusion criteria may apply
|