A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502916-35-01

Acronym

EDGE-Lung

Enrollment

171

Registered

2023-11-24

Start date

2024-03-27

Completion date

Unknown

Last updated

2025-09-10

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

Conditions

Advanced Non-Small Cell Lung Cancer

Brief summary

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by the investigator, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Detailed description

OS, PFS, Disease control rate (DCR), Duration of response (DoR), Plasma or serum concentration of investigational study treatments and estimated PK parameters, Percentage of biologic treatment-emergent antidrug antibody (ADA)-positive participants and ADA-negative participants

Interventions

DRUGDocetaxel AqVida 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed NeoCorp 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCISPLATINE TEVA 1 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INFUSIONSLÖSUNG

DRUGCarboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGDocetaxel Hikma 160 mg/8 ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatine Teva 1 mg/ml concentraat voor oplossing voor infusie

DRUGCisplatine Teva 1 mg/ml solution à diluer pour perfusion.

DRUGPemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion

DRUGCarboplatine Hikma 450 mg/45 ml solution pour perfusion

DRUGCarboplatine Hikma 450 mg/45 ml Infusionslösung

DRUGPaclitaxel AqVida 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatine Hikma 450 mg/45 ml oplossing voor infusie

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGPaclitaxel Ribosepharm 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGQuemliclustat

DRUGDOMVANALIMAB

DRUGZimberelimab

DRUGCisplatine 1 mg/ml PCH

DRUGconcentraat voor oplossing voor infusie

DRUGPemetrexed Ribosepharm 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed Hexal 25 mg/ml infuusiokonsentraatti

DRUGliuosta varten

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and assessed by the investigator, The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	—

Secondary

Measure	Time frame
OS, PFS, Disease control rate (DCR), Duration of response (DoR), Plasma or serum concentration of investigational study treatments and estimated PK parameters, Percentage of biologic treatment-emergent antidrug antibody (ADA)-positive participants and ADA-negative participants	—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

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