NCT02400814

MPDL3280A and Stereotactic Ablative Radiotherapy in Patients With Non-small Cell Lung Cancer

Terminated Phase 1 Last updated 4 August 2022

What this trial tests

Phase 1 trial testing Anti-PD-L1 Monoclonal Antibody MPDL3280A in Recurrent Non-Small Cell Lung Carcinoma in 27 participants. Terminated before completion.

Timeline

3 December 2015

Primary endpoint
29 September 2021

29 September 2021

Quick facts

Lead sponsor	Megan Daly, MD
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	3 December 2015
Primary completion	29 September 2021
Estimated completion	29 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Anti-PD-L1 Monoclonal Antibody MPDL3280A — full drug profile →
• Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

• Recurrent Non-Small Cell Lung Carcinoma — all drugs for Recurrent Non-Small Cell Lung Carcinoma →
• Stage IV Non-Small Cell Lung Cancer — all drugs for Stage IV Non-Small Cell Lung Cancer →

Sponsor

Megan Daly, MD — full company profile →

Who can join

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

Sponsor's own description

This pilot phase I trial compares administration schedules of anti-programmed cell death-1 ligand 1 (PD-L1) monoclonal antibody MPDL3280A and stereotactic ablative radiotherapy in treating patients with stage IV non-small cell lung cancer. Monoclonal antibodies, such as anti-PD-L1 monoclonal antibody MPDL3280A, may block tumor growth in different ways by targeting certain cells. Stereotactic ablative radiotherapy, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Giving anti-PD-L1 monoclonal antibody MPDL3280A with stereotactic ablative radiotherapy may be a better treatment for non-small cell lung cancer. However, it is not yet known what the best administration schedule is for these treatments.

Publications & conference data

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

1. Current clinical trials testing the combination of immunotherapy with radiotherapy.
   Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
2. The intersection of radiotherapy and immunotherapy: mechanisms and clinical implications.
   Spiotto M, Fu YX, Weichselbaum RR. · · 2016 · cited 177× · PMID 28018989 · DOI 10.1126/sciimmunol.aag1266
3. Immunotherapy with checkpoint inhibitors in non-small cell lung cancer: insights from long-term survivors.
   Nadal E, Massuti B, Dómine M, García-Campelo R, et al · · 2019 · cited 84× · PMID 30725206 · DOI 10.1007/s00262-019-02310-2
4. Trial Watch: Immunotherapy plus radiation therapy for oncological indications.
   Vacchelli E, Bloy N, Aranda F, Buqué A, et al · · 2016 · cited 61× · PMID 27757313 · DOI 10.1080/2162402x.2016.1214790
5. Lung Stereotactic Body Radiation Therapy and Concurrent Immunotherapy: A Multicenter Safety and Toxicity Analysis.
   Tian S, Switchenko JM, Buchwald ZS, Patel PR, et al · · 2020 · cited 48× · PMID 31982496 · DOI 10.1016/j.ijrobp.2019.12.030
6. Current Clinical Progress of PD-1/PD-L1 Immunotherapy and Potential Combination Treatment in Non-Small Cell Lung Cancer.
   Li JX, Huang JM, Jiang ZB, Li RZ, et al · · 2019 · cited 45× · PMID 31838881 · DOI 10.1177/1534735419890020
7. The evolving toxicity profile of SBRT for lung cancer.
   Thompson M, Rosenzweig KE. · · 2019 · cited 45× · PMID 30788234 · DOI 10.21037/tlcr.2018.10.06
8. Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.
   Kong Y, Ma Y, Zhao X, Pan J, et al · · 2021 · cited 34× · PMID 33859942 · DOI 10.3389/fonc.2021.638873