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

NCT04287894 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-11-06

No results posted yet for this study

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.

Conditions

  • Stage III NSCLC

Interventions

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • W Theelen, MD · NKI-AvL

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-28
Primary Completion
2024-11-04
Completion
2024-11-04

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287894 on ClinicalTrials.gov