Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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 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

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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +86 021 3183 7200Email iconEmail Study Center

Study Details


Contition
Non-Small Cell Lung Cancer
Age
18+
Phase
PHASE3
Participants Needed
500
Est. Completion Date
Oct 14, 2028
Treatment Type
INTERVENTIONAL

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov NCT Identifier
NCT05116462
Study Number
CIBI308G301

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