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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03044626
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy — DRUG
    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)
  • Nivolumab — DRUG
    Nivolumab 240 mg fixed dose (q2w)

Study Details

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.

Key Dates

Start date
Feb 10, 2017
Status verified
Jan 2021
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
101 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: study group A
    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)
  • Other: study group B
    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 Measure

objective response rate (ORR) according to RECIST 1.1 criteria [ Time Frame: through study completion, an average of 18 months ]

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