Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment — Induction  

Stage III NSCLC Clinical Trial

Official title: A Phase Ib, Open-label, Single-center Study to Assess the Safety of Cancer-immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment of Locally Advanced NSCLC.

Status Recruiting

Clinical Trial Summary

A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy in the treatment of locally advanced NSCLC.

Clinical Trial Description

Patients with pathologically proven stage III NSCLC will be treated with CIT-induction. In the feasibility phase, the first cohort (cohort 1A) will receive only 1 course of the immunotherapy doublet followed by a single dose of Durvalumab (Figure 1). The 2nd cohort (Figure 1, cohort 2A) will open for inclusion if 5 to 6 out of 6 patients complete CIT-CRT according to the safety rules (paragraph 6.1.3). In next cohort two courses of Tremelimumab and Durvalumab will be administered. The expansion cohort will be opened (Figure 1, cohort 2B) if this is well tolerated. Patients will be enrolled for cohort 1B in case < 5 out of 6 patients complete CIT-CRT in cohort 2A. ;

Related Conditions & MeSH terms

• Stage III NSCLC

• NCT number: NCT04287894
• Study type: Interventional
• Source: The Netherlands Cancer Institute
• Contact: W Theelen, MD
• Phone: 0031205129111
• Email: w.theelen@nki.nl
• Status: Recruiting
• Phase: Phase 1
• Start date: December 28, 2018
• Completion date: January 1, 2021