Poumon non à petites cellules

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  • ABBIL1TY NSCLC-06

TITRE (EN) 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
CLINICAL TRIAL.gov ID NCT06635824
TYPE(S) DE CANCER Poumon non à petites cellules
PHASE Phase III
TYPE D'ÉTUDE Clinique
INSTITUTION HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine
(514) 340-8222
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Jennifer Friedmann
COORDONATEUR(RICE) Martha Elbebawy
martha.elbebawy@ladydavis.ca
514-340-8222 poste 28224
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

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.
CRITÈRES D'EXCLUSION (EN)

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.