ABBIL1TY NSCLC-06 (GCT1046-06)
Research type
Research Study
Full 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 aPD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy (ABBIL1TY NSCLC-06)
IRAS ID
1010602
Contact name
Jacob Vemb Hansen
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2024-512998-27
Research summary
Lung cancer is one of the most common types of cancer, with nearly 2.5 million news cases diagnosed in 2022, leading about 1.8 million deaths worldwide. In the U.S. alone, the American Cancer Society estimates there will be around 234,580 new lung cancer cases and 125,070 deaths in 2024. Non-small cell lung cancer (NSCLC) makes up about 85% of lung cancers.
Genmab is the company that is the sponsor of this Research Trial. Genmab wants to see if a new medicine called acasunlimab, when used together with pembrolizumab, works better than the standard chemotherapy treatment (docetaxel) that is usually given to patients with NSCLC. To do this, a small sample of tumour will need to be tested to check the levels of a protein called PD-L1 using a test called VENTANA PD-L1 (SP263). This test will help Genmab decides if the patient can join the trial. Genmab also wants to learn more about the potential side effects patients may have when treated with acasunlimab in combination with pembrolizumab.
This combined trial is planned to run for up to 5 years. This includes:
Screening phase: A 28-day initial check to make sure that a potential participant is suitable for the study.
Treatment phase: Participants will have a 50/50 chance of receiving:
• Acasunlimab and pembrolizumab (Arm A) once every 6 weeks for up to 24 months
• Docetaxel every 3 weeks (Arm B) for as long as it benefits the participant, or until they have received the maximum number of cycles allowed by the local regulatory authority.
After the last dose of trial medication, participants will enter a 90-day safety follow-up period. Then a long-term follow-up visits or contact by email or telephone approximately every 12 weeks (or more frequently).
Approximately 702 patients worldwide will be invited to participate in this trial. About half (~351 patients) will receive acasunlimab in combination with pembrolizumab, whereas the other half will receive standard of care treatment with docetaxel.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0219
Date of REC Opinion
18 Nov 2024
REC opinion
Further Information Favourable Opinion