NCT03275597

Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Non-small Lung Cancer (NSCLC) With Dual Immune Checkpoint Inhibition

Terminated Phase 1 Last updated 15 May 2023

What this trial tests

Phase 1 trial testing Durvalumab in Non-small Cell Lung Cancer in 17 participants. Terminated before completion.

Timeline

20 February 2018

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	20 February 2018
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Durvalumab — full drug profile →
• Tremelimumab (TREMELIMUMAB) — full drug profile →
• Stereotactic Body Radiotherapy

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
• Non-small Cell Lung Cancer Stage IV — all drugs for Non-small Cell Lung Cancer Stage IV →

Sponsor

University of Wisconsin, Madison

Who can join

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

Sponsor's own description

This is a phase Ib study to evaluate safety and tolerability of dual checkpoint inhibition (DCI) of durvalumab (anti-PD-L1) and tremelimumab (anti-CTLA-4) with SBRT in the treatment of oligometastatic NSCLC. This study will examine the sequential delivery of SBRT to all disease sites followed by combination of durvalumab and tremelimumab for patients for whom the goal is ablating all known sites of disease. The investigators anticipate that for many participants this will be the first line-therapy. Participants who have received prior-platinum-based chemotherapy and/or any line of prior chemotherapy are eligible. Prior immunotherapy treatment is not allowed.

Publications & conference data

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

1. Radiotherapy combined with immunotherapy: the dawn of cancer treatment.
   Zhang Z, Liu X, Chen D, Yu J. · · 2022 · cited 463× · PMID 35906199 · DOI 10.1038/s41392-022-01102-y
2. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
3. Tumor immunotherapies by immune checkpoint inhibitors (ICIs); the pros and cons.
   Naimi A, Mohammed RN, Raji A, Chupradit S, et al · · 2022 · cited 350× · PMID 35392976 · DOI 10.1186/s12964-022-00854-y
4. Abscopal effect of radiotherapy combined with immune checkpoint inhibitors.
   Liu Y, Dong Y, Kong L, Shi F, et al · · 2018 · cited 337× · PMID 30115069 · DOI 10.1186/s13045-018-0647-8
5. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
6. SBRT combined with PD-1/PD-L1 inhibitors in NSCLC treatment: a focus on the mechanisms, advances, and future challenges.
   Chen Y, Gao M, Huang Z, Yu J, et al · · 2020 · cited 125× · PMID 32723363 · DOI 10.1186/s13045-020-00940-z
7. Circulating Tumor Cell PD-L1 Expression as Biomarker for Therapeutic Efficacy of Immune Checkpoint Inhibition in NSCLC.
   Kloten V, Lampignano R, Krahn T, Schlange T. · · 2019 · cited 76× · PMID 31374957 · DOI 10.3390/cells8080809
8. Targeting NK Cell Checkpoint Receptors or Molecules for Cancer Immunotherapy.
   Zhang C, Liu Y. · · 2020 · cited 75× · PMID 32714324 · DOI 10.3389/fimmu.2020.01295