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)
Trial tests new combo therapy for advanced lung cancer after prior treatment
Plain English Summary
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06) is a Phase 3 clinical trial sponsored by Genmab studying PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC. This trial tests if a combination of acasunlimab and pembrolizumab is better than docetaxel for treating a specific type of lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has spread or cannot be removed, and whose cancer has PD-L1 expression. Participants will be randomly assigned to receive either the new combination therapy or docetaxel, and will be monitored for about 5 years. Standard treatment options for this stage of lung cancer include chemotherapy and immunotherapy, but this trial explores a new combination for patients who have already received these treatments. The trial aims to enroll 191 participants.
Official 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 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with non-small cell lung cancer (NSCLC) that is locally advanced (cannot be removed) or has spread to other parts of the body. Patients must have cancer that expresses PD-L1 (a protein on cancer cells) and have previously been treated with a PD-1/PD-L1 inhibitor and chemotherapy. Patients must be in good general health with an ECOG performance status of 0 or 1 and have a life expectancy of at least 3 months. Patients with certain genetic mutations in their cancer (like EGFR, ALK, ROS1, KRAS, BRAF, MET) may not be eligible unless targeted therapies are not available. This trial is studying PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome, Overall Survival, measures how long patients live after starting treatment, indicating if the new combination therapy helps patients live longer than the standard treatment. The specific primary outcome measures are: Overall Survival (OS) (Up to approximately 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a critical need for new treatment options for patients with advanced non-small cell lung cancer who have progressed after initial immunotherapy and chemotherapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC, where improved treatment options are needed.
Investor Insight
This Phase 3 trial, sponsored by Genmab, investigates a novel combination therapy for a significant unmet need in the large NSCLC market, suggesting potential for a new treatment option if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if your cancer is PD-L1 positive and if you have received prior immunotherapy and chemotherapy. Understand that you will be randomly assigned to one of two treatment groups and will not know which one you are receiving. Be prepared for regular clinic visits for infusions, scans, and blood tests over several years. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 191 participants
Interventions
- DRUG: Acasunlimab — IV infusion
- DRUG: Pembrolizumab — IV infusion
- DRUG: Docetaxel — IV infusion
Primary Outcomes
- Overall Survival (OS) (Up to approximately 5 years)
Secondary Outcomes
- Progression-Free Survival (PFS) (Up to approximately 5 years)
- Confirmed Overall Response Rate (ORR) (Up to approximately 5 years)
- Duration of Response (DOR) (Up to approximately 5 years)
- Number of Participants With Adverse Events (AEs) (From first dose until the end of the study (approximately 5 years))
- Time to Treatment Discontinuation Due to AE (From first dose until the end of the study (approximately 5 years))
Full Eligibility Criteria
Key Inclusion Criteria: * Participant has histologically or cytologically confirmed locally advanced (unresectable stage IIIB/C) or metastatic NSCLC (stage IV) with known subtype. * Participant has progressed radiographically on or after receiving: * 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 * 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. * 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. * 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), 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. * Participants with known KRAS/BRAF mutations are eligible for the trial if they do not have access to targeted therapies. * Participants with newly identified, untreated or 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.
Trial Locations
- Arizona Blood and Cancer Specialists, Tucson, Arizona, United States
- Usc Norris Comprehensive Cancer Center, Los Angeles, California, United States
- Kaiser Permanente Vallejo Medical Center, Vallejo, California, United States
- Ocala Oncology Center P.L., Ocala, Florida, United States
- Orlando Regional Medical Center, Orlando, Florida, United States
- University Cancer & Blood Center, LLC, Athens, Georgia, United States
- Piedmont Cancer Institute Atlanta, Atlanta, Georgia, United States
- Piedmont Cancer Institute - Sandy Springs (Atlanta) Office, Atlanta, Georgia, United States
- Piedmont Cancer Institute - Fayetteville Office, Fayetteville, Georgia, United States
- Piedmont Cancer Institute - Newnan Office, Newnan, Georgia, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06635824?
NCT06635824 is a Phase 3 INTERVENTIONAL study titled "Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)." It is currently active, not recruiting and is sponsored by Genmab. The trial targets enrollment of 191 participants.
What conditions does NCT06635824 study?
This trial investigates treatments for PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC. The primary condition under study is PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC.
What treatments are being tested in NCT06635824?
The interventions being studied include: Acasunlimab (DRUG), Pembrolizumab (DRUG), Docetaxel (DRUG). IV infusion
What does Phase 3 mean for NCT06635824?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06635824?
This trial is currently "Active, Not Recruiting." It started on 2024-11-25. The estimated completion date is 2028-09-30.
Who is sponsoring NCT06635824?
NCT06635824 is sponsored by Genmab. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06635824?
The trial aims to enroll 191 participants. The trial status is active, not recruiting.
How is NCT06635824 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06635824?
The primary outcome measures are: Overall Survival (OS) (Up to approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06635824 being conducted?
This trial is being conducted at 20 sites, including Tucson, Arizona; Los Angeles, California; Vallejo, California; Ocala, Florida and 16 more sites (United States).
Where can I find official information about NCT06635824?
The official record for NCT06635824 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06635824. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06635824 testing in simple terms?
This trial tests if a combination of acasunlimab and pembrolizumab is better than docetaxel for treating a specific type of lung cancer. It is for patients with non-small cell lung cancer (NSCLC) that has spread or cannot be removed, and whose cancer has PD-L1 expression.
Why is this trial significant?
This trial addresses a critical need for new treatment options for patients with advanced non-small cell lung cancer who have progressed after initial immunotherapy and chemotherapy. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06635824?
Common side effects of acasunlimab and pembrolizumab can include fatigue, nausea, diarrhea, and skin rash. Docetaxel can cause side effects such as hair loss, fatigue, nausea, and a higher risk of infection. The combination therapy may lead to immune-related side effects where the immune system attacks healthy tissues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06635824?
Ask your doctor if your cancer is PD-L1 positive and if you have received prior immunotherapy and chemotherapy. Understand that you will be randomly assigned to one of two treatment groups and will not know which one you are receiving. Be prepared for regular clinic visits for infusions, scans, and blood tests over several years. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06635824 signal from an investment perspective?
This Phase 3 trial, sponsored by Genmab, investigates a novel combination therapy for a significant unmet need in the large NSCLC market, suggesting potential for a new treatment option if successful. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to receive either the new combination therapy or docetaxel, and will be monitored for about 5 years. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.