Thoracic Radiotherapy plus Durvalumab in Elderly and/or frail NSCLC stage III patients unfit for chemotherapy - Employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513948-28-00

Acronym

TRADE-hypo

Enrollment

Registered

2024-08-15

Start date

2020-05-08

Completion date

Unknown

Last updated

2025-11-19

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

Conditions

unresectable stage III NSCLC (Non–small-cell lung cancer)

Brief summary

Primary Endpoint: Toxicity, defined by the occurence of treatment-related pneumonitis grade ≥ 3, Primary Efficacy Endpoint: Objective response according to RECIST 1.1 criteria

Detailed description

Occurence of treatment-related AEs and SAEs according to CTCAE V5.0, Abnormal values of laboratory parameters, PFS according to RECIST 1.1, Duration of Clinical Benefit (Duration of CR, PR, SD) according to RECIST 1.1, MFS, OS, QoL (FACT-L), Descriptive sub-group analyses of efficacy in relation to PD-L1 expression levels (<°1% vs ≥°1%)

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: Toxicity, defined by the occurence of treatment-related pneumonitis grade ≥ 3, Primary Efficacy Endpoint: Objective response according to RECIST 1.1 criteria	—

Secondary

Measure	Time frame
Occurence of treatment-related AEs and SAEs according to CTCAE V5.0, Abnormal values of laboratory parameters, PFS according to RECIST 1.1, Duration of Clinical Benefit (Duration of CR, PR, SD) according to RECIST 1.1, MFS, OS, QoL (FACT-L), Descriptive sub-group analyses of efficacy in relation to PD-L1 expression levels (<°1% vs ≥°1%)	—

Countries

Germany

Outcome results

None listed

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