For Healthcare Professionals

Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer

clipboard-pencil

About the study

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).
user-3

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 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.

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. -

pin location

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.

Study’s details


Contition

Non-small Cell Lung Cancer (NSCLC)

Age (in years)

18+

Phase

Phase 3

Participants needed

800

Est. Completion Date

Jun 20, 2026

Treatment type

Interventional


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

ClinicalTrials.gov identifier

NCT05116462

Study number

CIBI308G301

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.