| Titre |
A Prospective, Open-Label, Randomized, Phase 3 Trial of Acasunlimab (GEN1046) in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy |
| Protocole ID |
ABBIL1TY NSCLC-06 |
| ClinicalTrials.gov ID |
NCT06635824 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
Acasunlimab avec pembrolizumab versus docetaxel |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dre Jennifer Friedmann
|
| Coordonnateur(trice) |
Martha Elbebawy
514-340-8222 poste 28224
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
Key Inclusion Criteria:
- Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV with known subtype).
-
Participant has progressed radiographically on or after receiving:
- One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the metastatic disease setting; OR
- No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the metastatic disease setting.
- Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the metastatic setting at a sponsor-designated central laboratory.
- Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
- Participant has a life expectancy of ≥3 months.
- Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.
|
| Critètes d'exclusion |
Key Exclusion Criteria:
-
Documentation of known targetable epidermal growth factor receptor (EGFR) sensitizing mutations, anaplastic lymphoma kinase (ALK), RET proto-oncogene (RET), ROS proto-oncogene 1; receptor tyrosine kinase (ROS1) rearrangement, Kirsten rat sarcoma virus (KRAS), B-Raf proto-oncogene (BRAF) mutations, and MET proto-oncogene; receptor tyrosine kinase (MET) exon 14 skipping mutations/MET amplification. NOTE: MET amplification testing is optional based on local availability of the test.
- Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to approved targeted therapies.
- Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
- Prior treatment with docetaxel for NSCLC.
- Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
- Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
|
Groupe d'étude en oncologie du Québec