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

NCT06635824 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 191

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC

Interventions

DRUG

Acasunlimab

IV infusion

DRUG

Pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2027-07-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635824 on ClinicalTrials.gov