Home › Trials › NCT06635824

Evaluating a new combination treatment for advanced lung cancer

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)

PHASE3 · Genmab · NCT06635824

This study is testing a new combination treatment for advanced lung cancer to see if it works better than standard chemotherapy for patients who have already tried other treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment702 (estimated)
Ages18 Years and up
SexAll
SponsorGenmab (industry)
Drugs / interventionschemotherapy, immunotherapy, acasunlimab, pembrolizumab
Locations32 sites (Ocala, Florida and 31 other locations)
Trial IDNCT06635824 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, open-label Phase 3 trial aims to assess the efficacy and safety of acasunlimab combined with pembrolizumab compared to standard chemotherapy with docetaxel in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC). Participants must have previously received treatment with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. The trial will also evaluate the quality of life of participants using standardized measurement scales. Patients will be assigned to one of two treatment arms, receiving either the experimental combination or standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic NSCLC that is PD-L1-positive and who have previously been treated with specific therapies.

Not a fit: Patients who have not received prior treatment with PD-1/PD-L1 inhibitors or platinum-based chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with advanced lung cancer, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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.

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), 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.

Where this trial is running

Ocala, Florida and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: PD-L1-positive Metastatic NSCLC, Lung Cancer, Solid Tumors, PD-L1, 4-1BB

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.