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

Phase 2

Completed

• Conditions: Lung Adenocarcinoma Metastatic; Metastatic Lung Cancer; Nonsmall Cell Lung Cancer; Large Cell Lung Carcinoma Metastatic; Carcinoma，Non-Small-Cell Lung
• Interventions: Drug: Radiotherapy; Drug: Nivolumab

• Registration Number: NCT03044626
• Lead Sponsor: AIO-Studien-gGmbH

Brief 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.

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-07
• Study Start: 2017-02-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group A	Radiotherapy	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: 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)
study group A	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: 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)
study group B	Nivolumab	Patients with metastatic non-squamous NSCLC without the necessity of radiotherapy in 2nd-line or 3rd-line treatment: Nivolumab 240 mg fixed dose (q2w).

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR) according to RECIST 1.1 criteria	through study completion, an average of 18 months

Secondary Outcome Measures

Name	Time	Method
progression free survival (PFS)	approx. 6 months
PFS using assessment according to irRECIST	approx. 6 months	Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST)
Overall Survival (OS)	approx. 57 months
Adverse Events	approx. 36 months	Adverse Events: Type, incidence, and severity according to NCI CTCAE version 4.03
ORR using assessment according to irRECIST	approx. 6 months	Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST)
Assesment of Quality of life	approx. 57 months	as determined with FACT-L (Functional Assessment of Cancer Therapy - Lung)

Trial Locations

Locations (16)

DRK Kliniken Berlin Mitte; 🇩🇪 Berlin, Germany

Evangelische Lungenklinik Berlin; 🇩🇪 Berlin, Germany

Krankenhaus Nordwest; 🇩🇪 Frankfurt / Main, Germany

Universitätsklinikum Carl-Gustav-Carus; 🇩🇪 Dresden, Germany

Klinikum Chemnitz; 🇩🇪 Chemnitz, Germany

LungenClinic Grosshansdorf; 🇩🇪 Großhansdorf, Germany

Klinikum Esslingen GmbH; 🇩🇪 Esslingen, Germany

Klinikverbund Kempten-Oberallgäu; 🇩🇪 Immenstadt, Germany

Klinik Löwenstein; 🇩🇪 Löwenstein, Germany

Kliniken der Stadt Köln Krankenhaus Merheim; 🇩🇪 Köln, Germany

Asklepios Fachkliniken München-Gauting; 🇩🇪 München-Gauting, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg/Saar, Germany

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany