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

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

NCT ID: NCT06635824

Condition: PD-L1-positive Metastatic NSCLC

Conditions: Official terms:
Lung Neoplasms
Pembrolizumab
Docetaxel

Conditions: Keywords:
Lung Cancer
Solid Tumors
PD-L1
4-1BB

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Acasunlimab
Description: IV infusion
Arm group label: Arm A

Other name: GEN1046

Other name: DuoBody®-PD-L1×4-1BB

Intervention type: Drug
Intervention name: Pembrolizumab
Description: IV infusion
Arm group label: Arm A

Intervention type: Drug
Intervention name: Docetaxel
Description: IV infusion
Arm group label: Arm B

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.

Detailed 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.

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Oncology Hematology West

Address:
City: Omaha
Zip: 68124
Country: United States

Status: Recruiting

Start date: November 30, 2024

Completion date: October 31, 2029

Lead sponsor:
Agency: Genmab
Agency class: Industry

Collaborator:
Agency: BioNTech SE
Agency class: Industry

Source: Genmab

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06635824