Overview

Concomitant Radiotherapy, Tremelimumab & Durvalumab for Advanced NSCLC Patients Progressing on First-line Immunotherapy

Status:
Not yet recruiting

Trial end date:
2026-09-01

Target enrollment:

Participant gender:

Summary

This is an open-label, single-arm, phase 2a trial with a safety run-in cohort followed by a Simon two-step design expansion cohort, of two checkpoint blockage treatments and radiotherapy in the treatment of locally advanced or metastatic NSCLC who have failed first-line immunotherapy (alone or as a combination regimen with chemotherapy). Study objectives: Objective of the safety run-in phase: • To evaluate safety of the triple combination of irradiation -Durvalumab - Tremelimumab Co-Primary objectives of the entire study: - To evaluate safety of the triple combination (as for the run-in phase). - To evaluate response rate on study drug compared to historical data of response to first-line platinum-doublet chemotherapy and 2nd-line docetaxel. Secondary objective: • To evaluate PFS and OS compared to historical data . Exploratory objectives: - Examine the mechanism of resistance to first-line immunotherapy . - Examine the immune response in irradiation -Durvalumab - Tremelimumab treated patients and identify potential predictors of clinical benefit.

Phase:

Phase 2

Details

Lead Sponsor:

Sheba Medical Center

Collaborators:

AstraZeneca
Rambam Health Care Campus
Tel-Aviv Sourasky Medical Center

Treatments:

Durvalumab
Tremelimumab