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

Last updated: March 3, 2025
Sponsor: Genmab
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Pembrolizumab

Docetaxel

Acasunlimab

Clinical Study ID

NCT06635824
GCT1046-06
2024-512998-27-00
jRCT2051240178
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Participant has histologically or cytologically confirmed metastatic NSCLC (stageIV).

  • Participant has progressed on or after receiving:

  • One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapyconcomitantly) in the metastatic disease setting; OR

  • No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-basedchemotherapy sequentially, irrespective of the order) in the metastatic diseasesetting.

  • Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determinedprospectively on a tumor sample from the metastatic setting at a sponsor-designatedcentral laboratory.

  • Participant has measurable disease according to RECIST v1.1 as assessed by theinvestigator 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 testresults within 7 days of trial treatment.

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 ratsarcoma virus (KRAS), BRAF mutations, and MET exon 14 skipping mutations/METamplification. NOTE: MET amplification testing is optional based on localavailability of the test.

  • Participants with known KRAS/BRAF mutations are eligible for the trial if theydo not have access to approved targeted therapies.

  • Participants with newly identified or known unstable or symptomatic central nervoussystem (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 trialtreatment.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Total Participants: 702
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 3
Study Start date:
November 25, 2024
Estimated Completion Date:
October 31, 2029

Study Description

The goal of this trial is to determine the efficacy and safety of acasunlimab (an experimental antibody also known as GEN1046 or DuoBody® PDL1x4-1BB) in combination with pembrolizumab (an antibody known as KEYTRUDA®) compared to that of docetaxel (a standard of care chemotherapy). During the trial, the participant's quality of life will also be evaluated using industry-standard scales of measurement. To be eligible, participants:

  1. must have lung cancer that has metastasized (spread)

  2. have tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)

  3. will have been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially.

Other eligibility criteria will also apply.

Participants will be assigned to 1 of 2 active therapies, also known as treatment arms, as follows:

  • Acasunlimab (100 mg) and pembrolizumab (400 mg) once every 6 weeks (Q6W), or

  • Docetaxel 75 mg/m^2 once every 3 weeks (Q3W).

The estimated trial duration for a participant will vary but may be up to 5 years, consisting of:

  • An optional 56-day pre-screening period

  • A 28-day screening period

  • Up to 2 years of treatment

  • A 90-day safety follow-up period

  • Post-treatment follow-up.

Connect with a study center

  • MHAT for women's health - Nadezhda, OOD

    Sofia,
    Bulgaria

    Active - Recruiting

  • CHU Angers - Hôpital Larrey

    Angers,
    France

    Active - Recruiting

  • Hôpital Ambroise Paré

    Boulogne Billancourt,
    France

    Active - Recruiting

  • Hôpital Privé du Confluent

    Nantes,
    France

    Active - Recruiting

  • CHU Rennes - Hopital Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku,
    Japan

    Active - Recruiting

  • NHO Kyushu Cancer Center

    Fukuoka-shi,
    Japan

    Active - Recruiting

  • NHO Hokkaido Cancer Center

    Hokkaido,
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of JFCR

    Koto City,
    Japan

    Active - Recruiting

  • NHO Nagoya Medical Center

    Nagoya,
    Japan

    Active - Recruiting

  • Miyagi Cancer Center

    Natori-shi,
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Osaka Medical and Pharmaceutical University Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Chungcheongbuk-do,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center Korea

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Antoni van Leeuwenhoek

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 917
    Puerto Rico

    Active - Recruiting

  • Pan American Oncology Trials, LLC

    San Juan, 902
    Puerto Rico

    Active - Recruiting

  • Barts Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Guy's Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Ocala Oncology Center P.L.

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Oncology Hematology West

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • Clinical Research Alliance

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • University of Tennessee Medical Center Cancer Institute

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

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