Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2026-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This study is a multi-regional, randomized, double-blind Phase 3 study to compare the efficacy and safety of sintilimab plus chemotherapy (sintilimab combination) vs placebo plus chemotherapy (placebo combination) before surgery and sintilimab vs placebo after surgery in treatment-naive subjects with resectable Stage IIB (primary tumor > 4 cm) to IIIB (resectable N2 only) non-small cell lung cancer (NSCLC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Docetaxel; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

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 IIB (primary tumor > 4 cm), 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. -