Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT04287894
Status:
TERMINATED
Last Update Posted:
2024-11-06
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Safety of Immunotherapy Induction With Tremelimumab and Durvalumab Prior to Chemoradiotherapy and/or Resection in the Treatment
Sponsor:
The Netherlands Cancer Institute
Organization:
Study Overview
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:
TERMINATED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on initially defined safety rules not continued with expansion phase of study (too much toxicity with neo-adjuvant immunotherapy)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Induction
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: