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Fostering Efficacy of Anti - PD-1 - Treatment: Nivolumab Plus Radiotherapy in Advanced NSCLC

NCT03044626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2021-01-13

No results posted yet for this study

Summary

AIO-YMO/TRK-0415 (FORCE) is a Phase 2, open-label of nivolumab, patients with metastatic non-squamous NSCLC with the necessity of radiotherapy of a metastatic site (e.g. bone) in 2nd-line or 3rd-line treatment for study group A and patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment for study Group B.

Conditions

  • Carcinoma，Non-Small-Cell Lung
  • Metastatic Lung Cancer
  • Nonsmall Cell Lung Cancer
  • Lung Adenocarcinoma Metastatic
  • Large Cell Lung Carcinoma Metastatic

Interventions

DRUG

Radiotherapy

Nivolumab 240 mg fixed dose (q2w). First dose followed by radiotherapy. Radiotherapy has to start at the latest 72 hours after nivolumab administration. Radiotherapy: A metastatic site will be treated with a radiation dose of 4 Gy for a total of 5 courses during a two week time interval (total dose 20 Gy)

DRUG

Nivolumab

Nivolumab 240 mg fixed dose (q2w)

Sponsors & Collaborators

Principal Investigators

  • Farastuk Bozorgmehr, Dr. · Department of Thoracic Oncology, Thoraxklinik at Heidelberg University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Germany

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 NCT03044626 on ClinicalTrials.gov