ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 locally advanced (unresectable stage IIIB/C) or 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 locally advanced (unresectable stage IIIB/C) or metastatic setting.

Official Title

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)

Quick Facts

Study Start:2024-11-25
Study Completion:2029-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06635824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or metastatic NSCLC (stage IV) with known subtype.
  2. * Participant has progressed radiographically on or after receiving:
  3. * One prior line of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy concomitantly) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting; OR
  4. * No more than 2 prior lines of therapy (PD-1/PD-L1 inhibitor and platinum-based chemotherapy sequentially, irrespective of the order) in the locally advanced (unresectable stage IIIB/C) or metastatic disease setting.
  5. * Participant must have positive tumor PD-L1 expression (tumor cells ≥1%) determined prospectively on a tumor sample from the locally advanced (unresectable stage IIIB/C) or metastatic setting at a sponsor-designated central laboratory.
  6. * Participant has measurable disease according to RECIST v1.1 as assessed by the investigator at baseline.
  7. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1.
  8. * Participant has a life expectancy of ≥3 months.
  9. * Participant must have adequate organ and bone marrow function, per laboratory test results within 7 days of trial treatment.
  1. * 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.
  2. * Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to targeted therapies.
  3. * Participants with newly identified, untreated or unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis.
  4. * Prior treatment with docetaxel for NSCLC.
  5. * Prior treatment with a 4-1BB (CD137) targeted agent, any type of antitumor vaccine, autologous cell immunotherapy, or any unapproved immunotherapy.
  6. * Treatment with an anticancer agent within 28 days prior to the first dose of trial treatment.

Contacts and Locations

Principal Investigator

Study Official
STUDY_DIRECTOR
Genmab

Study Locations (Sites)

Arizona Blood and Cancer Specialists
Tucson, Arizona, 85712
United States
Usc Norris Comprehensive Cancer Center
Los Angeles, California, 90089
United States
Kaiser Permanente Vallejo Medical Center
Vallejo, California, 94589
United States
Ocala Oncology Center P.L.
Ocala, Florida, 34474
United States
Orlando Regional Medical Center
Orlando, Florida, 32806
United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
United States
Piedmont Cancer Institute Atlanta
Atlanta, Georgia, 30318
United States
Piedmont Cancer Institute - Sandy Springs (Atlanta) Office
Atlanta, Georgia, 30328
United States
Piedmont Cancer Institute - Fayetteville Office
Fayetteville, Georgia, 30214
United States
Piedmont Cancer Institute - Newnan Office
Newnan, Georgia, 30265
United States
Piedmont Cancer Institute - Stockbridge Office
Stockbridge, Georgia, 30281
United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, 96817
United States
University of Illinois
Chicago, Illinois, 60612
United States
Community Cancer Center East Medical Oncology Hematology
Indianapolis, Indiana, 46219
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Pikeville Medical Center
Pikeville, Kentucky, 41501
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
St. Francis Hospital - Grand Island
Grand Island, Nebraska, 68803
United States
Oncology Hematology West
Omaha, Nebraska, 68124
United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Stony Brook University Medical Center|University Medical Center
Stony Brook, New York, 11790
United States
Novant Health Pharmacy
Charlotte, North Carolina, 28204
United States
Novant Health Oncology Specialists
Winston-Salem, North Carolina, 27103
United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404
United States
University of Tennessee Medical Center Cancer Institute
Knoxville, Tennessee, 37920
United States
Midtown Tennessee Oncology
Nashville, Tennessee, 37203
United States
Tennessee Oncology
Nashville, Tennessee, 37205
United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705
United States
Texas Oncology-Austin Central
Austin, Texas, 78731
United States
South Austin Cancer Ctr
Austin, Texas, 78745
United States
University of Virginia Hematology and Oncology
Charlottesville, Virginia, 22903
United States
Cancer Institute At Swedish Med Ctr
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Genmab

  • Study Official, STUDY_DIRECTOR, Genmab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2029-10-31

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2029-10-31

Terms related to this study

Keywords Provided by Researchers

  • Lung Cancer
  • Solid Tumors
  • PD-L1
  • 4-1BB

Additional Relevant MeSH Terms

  • PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC