NCT05891080

Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial

Not yet recruiting Phase 2 Last updated 6 June 2023

What this trial tests

Phase 2 trial testing Toripalimab in Stage III Non-small Cell Lung Cancer in 124 participants. Not yet recruiting.

Timeline

1 July 2023

Primary endpoint
1 July 2025

1 July 2030

Quick facts

Lead sponsor	Shanghai Pulmonary Hospital, Shanghai, China
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	1 July 2023
Primary completion	1 July 2025
Estimated completion	1 July 2030

Drugs / interventions tested

• Toripalimab (TORIPALIMAB) — full drug profile →
• JS004
• Pemetrexed — full drug profile →
• Nab-paclitaxel (nab-paclitaxel) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Surgery

Conditions studied

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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Who can join

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

Sponsor's own description

For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.

Publications & conference data

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

1. Beyond the anti-PD-1/PD-L1 era: promising role of the BTLA/HVEM axis as a future target for cancer immunotherapy.
   Sordo-Bahamonde C, Lorenzo-Herrero S, Granda-Díaz R, Martínez-Pérez A, et al · · 2023 · cited 64× · PMID 37649037 · DOI 10.1186/s12943-023-01845-4
2. Targeting T cell exhaustion: emerging strategies in non-small cell lung cancer.
   Liu X, Xi X, Xu S, Chu H, et al · · 2024 · cited 40× · PMID 39726592 · DOI 10.3389/fimmu.2024.1507501
3. BTLA biology in cancer: from bench discoveries to clinical potentials.
   Andrzejczak A, Karabon L. · · 2024 · cited 34× · PMID 38233898 · DOI 10.1186/s40364-024-00556-2
4. Tumor necrosis factor superfamily signaling: life and death in cancer.
   Ababneh O, Nishizaki D, Kato S, Kurzrock R. · · 2024 · cited 18× · PMID 39363128 · DOI 10.1007/s10555-024-10206-6
5. Unlocking new frontiers: novel immune targets for next-generation cancer immunotherapy.
   Zaheer S, Sureka N. · · 2025 · cited 1× · PMID 40916400 · DOI 10.14216/kjco.24322
6. Advancing neoadjuvant therapies in resectable non-small cell lung cancer: implications for novel treatment strategies and biomarker discovery.
   Jeon H, Gor R, D'Aiello A, Stiles B, et al · · 2024 · cited 1× · PMID 38957347 · DOI 10.3389/pore.2024.1611817