Dual-immunotherapy and short-course medium-dose radiotherapy, followed by surgery for tumor microenvironment modification in early-stage NSCLC: the DIRECT-trial

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516580-87-00

Enrollment

Registered

2024-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-29

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

Conditions

early stage NSCLC

Brief summary

Safety defined as the percentage of patients with adverse events., Major pathological response (MPR) and pathological complete response (pCR) rates in resected tumor-specimens.

Detailed description

Tumor immune infiltration after durvalumab and RT in 4 categories., Radiological response to durvalumab and RT using RECIST v1.1 criteria, and metabolic response based on 18F-FDG PET.

Interventions

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Tumor immune infiltration after durvalumab and RT in 4 categories., Radiological response to durvalumab and RT using RECIST v1.1 criteria, and metabolic response based on 18F-FDG PET.	—

Primary

Measure	Time frame
Safety defined as the percentage of patients with adverse events., Major pathological response (MPR) and pathological complete response (pCR) rates in resected tumor-specimens.	—

Countries

Netherlands

Outcome results

None listed

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