NCT03044626

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective is to investigate efficacy of a nivolumab-radiotherapy combination treatment in metastatic non-squamous NSCLC patients.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-02-10
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-02-07
• Last updated: 2021-01-13

Locations

16 sites across 1 country: Germany