A Phase 2, multicenter, randomized, open-label trial of GEN1046 as monotherapy and in combination with Pembrolizumab in subjects with relapsed/refractory metastatic non-small cell lung cancer after treatment with standard care therapy with a immune checkpoint inhibitor.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513770-22-00

Acronym

GCT1046-04

Enrollment

100

Registered

2024-09-19

Start date

2021-09-22

Completion date

Unknown

Last updated

2025-09-30

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

Conditions

Malignant Solid Tumors - Non Small Cell Lung Cancer

Brief summary

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator

Detailed description

Duration of response (DOR) per RECIST v1.1. -, Time to response (TTR) per RECIST v1.1., Progression-free survival (PFS) per RECIST v1.1, Overall survival (OS), Incidence and severity of adverse events (AEs), Incidence and severity of laboratory abnormalities

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGAcasunlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by investigator	—

Secondary

Measure	Time frame
Duration of response (DOR) per RECIST v1.1. -, Time to response (TTR) per RECIST v1.1., Progression-free survival (PFS) per RECIST v1.1, Overall survival (OS), Incidence and severity of adverse events (AEs), Incidence and severity of laboratory abnormalities	—

Countries

France, Germany, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

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