NCT03044626: FORCE

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

Completed Phase 2 Last updated 13 January 2021

What this trial tests

Phase 2 trial testing Radiotherapy in Carcinoma，Non-Small-Cell Lung in 101 participants. Completed in 31 December 2020.

Timeline

10 February 2017

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	AIO-Studien-gGmbH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	10 February 2017
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	16 locations across Germany

Drugs / interventions tested

• Radiotherapy — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Carcinoma，Non-Small-Cell Lung — all drugs for Carcinoma，Non-Small-Cell Lung →
• Metastatic Lung Cancer — all drugs for Metastatic Lung Cancer →
• Nonsmall Cell Lung Cancer — all drugs for Nonsmall Cell Lung Cancer →
• Lung Adenocarcinoma Metastatic — all drugs for Lung Adenocarcinoma Metastatic →

Sponsor

AIO-Studien-gGmbH — full company profile →

Who can join

18 and older, any sex, with Carcinoma，Non-Small-Cell Lung or Metastatic Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation-induced tumor immune microenvironments and potential targets for combination therapy.
   Guo S, Yao Y, Tang Y, Xin Z, et al · · 2023 · cited 136× · PMID 37208386 · DOI 10.1038/s41392-023-01462-z
2. Advances in Anti-Cancer Immunotherapy: Car-T Cell, Checkpoint Inhibitors, Dendritic Cell Vaccines, and Oncolytic Viruses, and Emerging Cellular and Molecular Targets.
   Alard E, Butnariu AB, Grillo M, Kirkham C, et al · · 2020 · cited 62× · PMID 32645977 · DOI 10.3390/cancers12071826
3. Combining immunotherapy and radiotherapy in lung cancer.
   Bhalla N, Brooker R, Brada M. · · 2018 · cited 50× · PMID 29951296 · DOI 10.21037/jtd.2018.05.107
4. Current Prospects for Treatment of Solid Tumors via Photodynamic, Photothermal, or Ionizing Radiation Therapies Combined with Immune Checkpoint Inhibition (A Review).
   Anand S, Chan TA, Hasan T, Maytin EV. · · 2021 · cited 44× · PMID 34068491 · DOI 10.3390/ph14050447
5. Is the Combination of Immunotherapy and Radiotherapy in Non-small Cell Lung Cancer a Feasible and Effective Approach?
   Spaas M, Lievens Y. · · 2019 · cited 31× · PMID 31788476 · DOI 10.3389/fmed.2019.00244
6. Fostering efficacy of anti-PD-1-treatment: Nivolumab plus radiotherapy in advanced non-small cell lung cancer - study protocol of the FORCE trial.
   Bozorgmehr F, Hommertgen A, Krisam J, Lasitschka F, et al · · 2019 · cited 28× · PMID 31703637 · DOI 10.1186/s12885-019-6205-0
7. Synergistic effect of immunotherapy and radiotherapy in non-small cell lung cancer: current clinical trials and prospective challenges.
   Yang H, Jin T, Li M, Xue J, et al · · 2019 · cited 26× · PMID 35694698 · DOI 10.1093/pcmedi/pbz004
8. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
   Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744