Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non‑Small Cell Lung Cancer (ABBIL1TY NSCLC‑06)

Trial status:Recruiting
Trial ID:
GCT1046-06
NCT ID:
NCT06635824
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2024-512998-27-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Genmab
Collaborator:
BioNTech SE
Recruiting

Trial Details

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.

Medical Condition
  • Lung Cancer
    • Study Drug
  • Acasunlimab
    • See more
  • Pembrolizumab
  • Docetaxel
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    702
    Estimated Trial Date
    Nov 2024 - Jan 2027

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria
    • Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV).
    • Participant has progressed 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.
    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), BRAF mutations, and 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.

    Trial Locations

    Location
    Status
    Location
    Ocala Oncology Center P.L.
    Ocala, Florida, United States, 34474
    Status
    Recruiting
    Location
    Norton Cancer Institute
    Louisville, Kentucky, United States, 40202
    Status
    Recruiting
    Location
    Washington University School of Medicine
    Saint Louis, Missouri, United States, 63110
    Status
    Recruiting
    Location
    Oncology Hematology West
    Omaha, Nebraska, United States, 68124
    Status
    Recruiting
    Location
    Clinical Research Alliance
    Westbury, New York, United States, 11590
    Status
    Recruiting
    Location
    Avera Cancer Institute
    Sioux Falls, South Dakota, United States, 57105
    Status
    Recruiting
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