NCT03732664

ICIs Neoadjuvant Therapy in Resectable Non-Small-Cell Lung Cancer

Completed Phase 1 Last updated 24 March 2023

What this trial tests

Phase 1 trial testing Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Sintilimab, Tislelizumab, Durvalumab in High-Risk Resectable NSCLC in 27 participants. Completed in 23 March 2023.

Timeline

1 October 2018

Primary endpoint
23 March 2023

23 March 2023

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 October 2018
Primary completion	23 March 2023
Estimated completion	23 March 2023
Sites	1 location across China

Drugs / interventions tested

• Nivolumab, Pembrolizumab, Toripalimab, Sintilimab, Sintilimab, Tislelizumab, Durvalumab — full drug profile →

Conditions studied

• High-Risk Resectable NSCLC — all drugs for High-Risk Resectable NSCLC →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

18 and older, any sex, with High-Risk Resectable NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 or anti-PD-L1 in NSCLC, both in the peri-operative and advanced disease setting.

Publications & conference data

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

1. Advances in cancer immunotherapy 2019 - latest trends.
   Kruger S, Ilmer M, Kobold S, Cadilha BL, et al · · 2019 · cited 376× · PMID 31217020 · DOI 10.1186/s13046-019-1266-0
2. 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
3. Surgery after Induction Targeted Therapy and Immunotherapy for Lung Cancer.
   Allaeys T, Berzenji L, Van Schil PE. · · 2021 · cited 18× · PMID 34073302 · DOI 10.3390/cancers13112603
4. Expert consensus on perioperative immunotherapy for local advanced non-small cell lung cancer.
   Qiu B, Cai K, Chen C, Chen J, et al · · 2021 · cited 17× · PMID 34733623 · DOI 10.21037/tlcr-21-634
5. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC.
   Yi C, He Y, Xia H, Zhang H, et al · · 2019 · cited 17× · PMID 31564915 · DOI 10.2147/ott.s218321
6. Expert consensus on perioperative treatment for non-small cell lung cancer.
   Duan J, Tan F, Bi N, Chen C, et al · · 2022 · cited 13× · PMID 35958323 · DOI 10.21037/tlcr-22-527
7. New developments in locally advanced nonsmall cell lung cancer.
   Huber RM, Kauffmann-Guerrero D, Hoffmann H, Flentje M. · · 2021 · cited 12× · PMID 33952600 · DOI 10.1183/16000617.0227-2020
8. Neoadjuvant immunotherapy for resectable non-small cell lung cancer.
   Xie H, Shi X, Wang G. · · 2021 · cited 10× · PMID 34249414