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Clinical Trials in China / NCT05116462
Active, not recruiting Phase 3

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

NCT05116462 · tracked via the Priya Life Science China tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 3
Started
2024-03-15
Last updated
2025-06-26

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pemetrexed →Carboplatin →Paclitaxel →Sintilimab →Cisplatin →Nab paclitaxel →Placebo

Pemetrexed: 500 mg/m2 D1 IV Q3W

Carboplatin: AUC 5 or 6 mg/ml/min D1 IV Q3W

Paclitaxel: 175 or 200 mg/m2 D1 IV Q3W

Sintilimab: 200 mg D1 IV Q3W

Cisplatin: 75 mg/m2 D1 IV Q3W

Nab paclitaxel: 100 mg/m2 D1, 8, 15 IV Q3W

Placebo: 20 ml D1 IV Q3W

Study summary

This study is a randomized, double-blind Phase 3 study to compare the efficacy and safety of Sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for Resectable Stage II to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Subjects must sign the written informed consent form (ICF), and be able to follow the visits and relevant procedures specified in the protocol. 2. Age ≥ 18 years. 3. Cytologically or histologically confirmed primary NSCLC (including adenocarcinoma, squamous cell carcinoma). 4. Subjects with Stage II, IIIA or IIIB (resectable N2 only) disease based on the 8th edition of the TNM staging classification for lung cancer issued by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification (AJCC8). 5. Deemed radically resectable with curative intent. 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 7. Have not received any prior systemic anti-tumor therapy or local radiotherapy for NSCLC. Exclusion Criteria: 1. Subjects with confirmed or suspected brain metastases. 2. Currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization. 3. Received Chinese herbal medicine, Chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization 4. Received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study). 5. Requiring long term systemic corticosteroids 6. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive), known active syphilis. 7. Active hepatitis B.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality

More Innovent Biologics (Suzhou) Co. Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05116462 on ClinicalTrials.gov ↗ ← All trials in China