Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
The goal of this trial is to determine the efficacy and safety of Acasunlimab immunotherapy in combination with Pembrolizumab immunotherapy, compared to that of Docetaxel (a standard of care chemotherapy). During the trial, participants' quality of life will also be evaluated.
To be eligible, participants:
- must have lung cancer that has metastasised (spread).
- have tumours that are positive for PD-L1 proteiin ( a biomarker that may be predictive of response to therapy)
- will have been previously treated with a PD-1/PD-L1 inhibitor and a platinum-containing cancer therapy administered in combination or sequentially.
Eligible participants will be randomly assigned to one of two active treatment arms:
- Experimental Arm: Acasunlimab and Pembrolizumab once every 6 weeks as an intravenous (IV) infusion, or
- Active Comparator Arm: Docetaxel IV infusion once every 3 weeks.
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.
Conditions
This trial is treating people with metastatic non-small cell lung cancer (Stage IV) that is PD-L1+ and who have had prior treatment
Eligibility
Exclusion
-
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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT06635824 *
- GCT1046-06; 2024-512998-27-00; JRCT2051240178
Trial sponsor
Genmab
Scientific 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)
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