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Search / Trial NCT05088967

Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Oct 11, 2021

Trial Information

Current as of July 24, 2025

Terminated

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Have NSCLC that has been classified as stage IIB (primary tumor \> 4 cm), IIIA, or IIIB (N2 only) per the 8th edition of TNM staging system of International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC).
  • 2. Subjects with non-squamous NSCLC should undergo genetic testing to confirm the absence of epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements;
  • 3. Eligible for radical resection (R0 resection) at the thoracic surgeon's discretion, and the lung function meets the criteria for planned surgery;
  • 4. Have at least one measurable lesion per RECIST v1.1 criteria;
  • 5. Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)
  • Exclusion Criteria:
  • 1. Have pathological evidence for small cell carcinoma, neuroendocrine carcinoma, sarcoma, lymphoepithelial rumen carcinoma, salivary gland tumor, or mesenchymal tumor from the biopsy.
  • 2. Have been previously exposed to immune-mediated therapies, including but not limited to LAG-3 antibody drugs, anti-cytotoxic T lymphocyte antigen-4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.

About Innovent Biologics (Suzhou) Co. Ltd.

Innovent Biologics (Suzhou) Co., Ltd. is a leading biotechnology company dedicated to the development and commercialization of innovative biologic therapies for the treatment of cancer, autoimmune diseases, and other serious conditions. Founded in 2011, Innovent focuses on the discovery and development of monoclonal antibodies and other biologic agents, leveraging advanced technology platforms to address unmet medical needs. With a strong commitment to research and development, the company collaborates with international partners and healthcare professionals to bring cutting-edge therapeutics to market, ultimately improving patient outcomes and quality of life.

Locations

Tianjin, Tianjin, China

Tianjin, Tianjin, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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