NCT04271384

Stereotactic Ablative Radiotherapy With Nivolumab for Early-Stage Operable Non-Small Cell Lung Cancer

Completed Phase 2 Last updated 26 December 2023

What this trial tests

Phase 2 trial testing nivolumab in Non-small Cell Lung Cancer Stage I in 25 participants. Completed in 15 November 2023.

Timeline

12 February 2020

Primary endpoint
15 November 2023

15 November 2023

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	12 February 2020
Primary completion	15 November 2023
Estimated completion	15 November 2023
Sites	1 location across Brazil

Drugs / interventions tested

• nivolumab (nivolumab) — full drug profile →

Conditions studied

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

Sponsor

Hospital Israelita Albert Einstein

Who can join

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

Sponsor's own description

Stage 1 non-small cell lung cancer (NSCLC) carries up to 30% chance of relapse in 5 years. This a phase 2 study that aims to determine the pathological complete response of the combination of stereotactic ablative radiotherapy (SABR) plus nivolumab as neoadjuvant treatment in early-stage non-small cell lung cancer. The patients will receive standard SABR + nivolumab at a dose of 360 mg every 21 days for 3 doses. The patient will undergo surgery 10 weeks after the last radiotherapy dose.

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. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
   Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
3. Combined treatment of non-small cell lung cancer using radiotherapy and immunotherapy: challenges and updates.
   Shang S, Liu J, Verma V, Wu M, et al · · 2021 · cited 68× · PMID 34658186 · DOI 10.1002/cac2.12226
4. Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
   Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7
5. Novel insights on gut microbiota manipulation and immune checkpoint inhibition in cancer (Review).
   Vivarelli S, Falzone L, Leonardi GC, Salmeri M, et al · · 2021 · cited 21× · PMID 34396439 · DOI 10.3892/ijo.2021.5255
6. A narrative review from gut to lungs: non-small cell lung cancer and the gastrointestinal microbiome.
   Shah H, Ng TL. · · 2023 · cited 17× · PMID 37197624 · DOI 10.21037/tlcr-22-595
7. Beyond success: unveiling the hidden potential of radiotherapy and immunotherapy in solid tumors.
   Wu Y, Yi M, Niu M, Zhou B, et al · · 2024 · cited 14× · PMID 38837878 · DOI 10.1002/cac2.12576
8. Neoadjuvant SBRT combined with immunotherapy in NSCLC: from mechanisms to therapy.
   Shi Y, Ma X, He D, Dong B, et al · · 2023 · cited 14× · PMID 37600799 · DOI 10.3389/fimmu.2023.1213222