NCT04287894

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

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage III NSCLC

Interventions

Type	Name	Description
DRUG	Durvalumab	The IP will be given to the patient as long as there is a clinical benefit, in invertigator's judgment. Per day, 1500 mg
DRUG	Tremelimumab	Per day 75mg
DRUG	Pemetrexed	500 mg/m2 on day 1 every 3 weeks for 2 cycles
DRUG	Cisplatin	6 mg / m2 on day 1 every 3 weeks for 2 cycles
RADIATION	chemo radiotherapy	Once-daily fraction, 2 Gy per fraction. Total dose is 60 Gy.
PROCEDURE	Resection	After CIT-CRT

Timeline

• Start date: 2018-12-28
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2020-02-27
• Last updated: 2024-11-06

Locations

1 site across 1 country: Netherlands