Informations générales (source: ClinicalTrials.gov)
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 (ABBIL1TY NSCLC-06)
Interventional
Phase 3
Genmab (Voir sur ClinicalTrials)
novembre 2024
octobre 2029
09 juillet 2025
This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate
the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel
(standard of care) in participants with programmed death ligand 1 (PD-L1)-positive
metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell
death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered
either in combination or sequentially in the metastatic setting.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique-Hôpitaux de Marseille - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la côte Basque - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - Lyon Cedex - France | Contact (sur clinicalTrials) | ||||
| CH de Mulhouse - Hôpital Emile Muller - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Hôpital Larrey - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - Hopital Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Clinique Belharra - Bayonne - Pyrenees Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Hopital Albert Calmette - CHU Lille - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Hôpital Ambroise Paré - Boulogne Billancourt - France | Contact (sur clinicalTrials) | ||||
| Hôpital Privé du Confluent - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Sainte Musse - Toulon - France | Contact (sur clinicalTrials) | ||||
| ICO - Site René Gauducheau - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - Bordeaux cedex - Gironde - France | Contact (sur clinicalTrials) | ||||
| Institut Gustave Roussy - Villejuif cedex - Val De Marne - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - Avignon Cedex 9 - Vaculuse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
Key
- 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.
Key
- 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.