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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512998-27-00

Acronym

GCT1046-06

Enrollment

398

Registered

2025-01-22

Start date

2025-02-21

Completion date

Unknown

Last updated

2025-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

Overall survival (OS)

Detailed description

Progression-free survival (PFS), Confirmed objective response rate (ORR), Duration of response (DoR), Number of participants with adverse events (AEs), Time to treatment discontinuation due to AE, Plasma concentration of acasunlimab, Number of participants with anti-drug antibodies (ADAs) to acasunlimab, Change from baseline in Functional Assessment of Cancer Therapy item GP5 (FACIT-GP5, version 4) score, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Interventions

DRUGMETHYLPREDNISOLONE

DRUGCellCept 500 mg film-coated tablets

DRUGPREDNISONE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGDOCETAXEL

DRUGANAKINRA

DRUGRoActemra 20 mg/mL concentrate for solution for infusion

DRUGDEXAMETHASONE

DRUGAcasunlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Progression-free survival (PFS), Confirmed objective response rate (ORR), Duration of response (DoR), Number of participants with adverse events (AEs), Time to treatment discontinuation due to AE, Plasma concentration of acasunlimab, Number of participants with anti-drug antibodies (ADAs) to acasunlimab, Change from baseline in Functional Assessment of Cancer Therapy item GP5 (FACIT-GP5, version 4) score, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	—

Measure

Time frame

—

Countries

Austria, Belgium, Bulgaria, Croatia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026