NCT05157776 is a Phase 3 clinical trial of PD-1 and chemotherapy in NSCLC, Stage IIIA, sponsored by Tongji University.

Who is sponsoring NCT05157776?

NCT05157776 is sponsored by Tongji University.

What drugs are being tested in NCT05157776?

Interventions in NCT05157776: PD-1 and chemotherapy.

What condition does NCT05157776 study?

NCT05157776 studies NSCLC, Stage IIIA, EGF-R Negative Non-Small Cell Lung Cancer, ALK Negative NSCLC.

Is NCT05157776 still recruiting?

NCT05157776 is currently status unknown. Last updated 9 May 2023.

Last reviewed 2023-05-09 · How we verify

NCT05157776

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III Trial of Neoadjuvant Sintilimab and Chemotherapy for NSCLC Harboring No Driver Mutations

Status unknown Phase 3 Last updated 9 May 2023

What this trial tests

Phase 3 trial testing PD-1 and chemotherapy in NSCLC, Stage IIIA in 72 participants. Status unknown.

Timeline

28 October 2021

Primary endpoint
31 October 2024

31 October 2025

Quick facts

Lead sponsor	Tongji University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	28 October 2021
Primary completion	31 October 2024
Estimated completion	31 October 2025
Sites	1 location across China

Drugs / interventions tested

PD-1 and chemotherapy — full drug profile →

Conditions studied

NSCLC, Stage IIIA — all drugs for NSCLC, Stage IIIA →
EGF-R Negative Non-Small Cell Lung Cancer — all drugs for EGF-R Negative Non-Small Cell Lung Cancer →
ALK Negative NSCLC — all drugs for ALK Negative NSCLC →

Sponsor

Tongji University

Who can join

Adults 18 to 75, any sex, with NSCLC, Stage IIIA or EGF-R Negative Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer. The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD

Publications & conference data

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

Increasing cure rates of solid tumors by immune checkpoint inhibitors.
Ma W, Xue R, Zhu Z, Farrukh H, et al · · 2023 · cited 84× · PMID 36647169 · DOI 10.1186/s40164-023-00372-8
Advances in molecular pathology and therapy of non-small cell lung cancer.
Huang Q, Li Y, Huang Y, Wu J, et al · · 2025 · cited 43× · PMID 40517166 · DOI 10.1038/s41392-025-02243-6
New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.
Houda I, Dickhoff C, Uyl-de Groot CA, Reguart N, et al · · 2024 · cited 22× · PMID 38476748 · DOI 10.1016/j.lanepe.2024.100840
Neoadjuvant immunotherapy for non-small cell lung cancer: Opportunities and challenges.
Hu J, Zhang J, Wan S, Zhang P. · · 2024 · cited 6× · PMID 39834585 · DOI 10.1016/j.pccm.2024.11.003
A narrative review on perioperative systemic therapy in non-small cell lung cancer.
Hsu R, Arter ZL, Poei D, Benjamin DJ. · · 2024 · cited 3× · PMID 39280253 · DOI 10.37349/etat.2024.00256
Drug development and evidence for lung cancer targeted therapy in Eastern Asia.
Maggie Liu SY, Jin ZY, Deng JY, Zhong SM, et al · · 2024 · cited 2× · PMID 39381018 · DOI 10.1016/j.lanwpc.2024.101090
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
Dynamic circulating tumor DNA indicates pathological benefits of additional neoadjuvant chemoimmunotherapy courses for locally advanced non-small-cell lung cancer patients.
Lin D, Wu L, Wang P, Li X, et al · · 2025 · PMID 40777124 · DOI 10.3389/fonc.2025.1563315

Verify or expand the search:

Other recruiting trials for NSCLC, Stage IIIA

Currently open trials in the same condition.

NCT04865250 — Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC · Phase 2 · recruiting

Other Tongji University trials

Trials by the same sponsor.

NCT07361237 — A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor E · Phase 1 · recruiting
NCT07208123 — Mechanistic Studies of Chronic COPD Using Single-Cell Sequencing and Single-Cell Spatial Transcriptomics · not yet recruiting
NCT07047859 — Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy · not yet recruiting
NCT07074704 — tACS to Improve Negative Symptoms & Cognition in Long-term Hospitalized Schizophrenia Patients. · NA · enrolling by invitation
NCT06740188 — Trazodone on NREM Sleep Stage Ⅲ in Depressed Insomniac Co-morbid Patients · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05157776 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tongji University
Last refreshed: 9 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05157776.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing