NCT04351256

Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).

Detailed description

This trial investigates the feasibility and treatment efficacy when combining durvalumab treatment with either conventionally fractionated (CON-group) or hypofractionated thoracic radiotherapy (HYPO-group) in previously untreated NSCLC stage III patients prone to radiotherapy only. A safety lead-in phase with stop-and-go design will precede full enrollment into the HYPO-group. Tumor tissue as well as blood and stool samples will be collected for future biomarker analysis. It is hypothesized that TRT combined with concurrent durvalumab administration in patients with unresectable stage III NSCLC, who are not amenable to sequential radio-/chemotherapy 1. is safe and feasible, 2. will improve treatment efficacy by a synergistic effect of checkpoint inhibition and the photon-induction of immunostimulatory pathways. 3. will have an effect on the immunological characteristics of the tumor, the microenvironment, and the systemic immune response, such as upregulation of PD-L1 or secretion of stimulatory cytokines and recruitment and priming of immunocompetent cells, which might then mediate the "abscopal effect" beyond the irradiated targets.

Conditions

• NSCLC, Stage III

Interventions

Type	Name	Description
DRUG	Durvalumab Injection [Imfinzi]	Durvalumab fixed dose of 1,500 mg
RADIATION	Thoracic Radiotherapy (TRT) conventionally	Conventionally fractionated TRT consisting of 30 x 2 Gy (60 Gy) within 6 weeks
RADIATION	Thoracic Radiotherapy (TRT) hypofractionated	Hypofractionated TRT consisting of 20 x 2,75 Gy (55 Gy) within 4 weeks

Timeline

• Start date: 2020-05-20
• Primary completion: 2026-01-21
• Completion: 2026-01-21
• First posted: 2020-04-17
• Last updated: 2026-03-27

Locations

14 sites across 1 country: Germany