IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

In brief

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.

Key facts

Study ID

NCT07122687

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

170

Starts

2025-08-26

Expected to finish

2030-04-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females, age ≥18 years and ≤75 years;
• Histologically or cytologically confirmed primary non-squamous NSCLC:
• Stage IB, II, IIIA or IIIB (N2) NSCLC (per AJCC8);
• No administration of any anti-NSCLC therapy in the pre-operative period;
• Be able to undergo the radical resection; Pulmonary function capacity capable of tolerating the proposed lung resection according to the surgeon.
• Participants without EGFR mutations or ALK translocation;
• At least 1 measurable lesion per RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
• Adequate organ function confirmed at screening period.

You may not qualify if…

• Histologically confirmed the presence of small cell lung cancer, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components, or mixed NSCLC with predominant squamous cell carcinoma features;
• Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
• Pancoast tumor;
• Malignant tumor nodule in the contralateral lung lobe;
• Participants with known or suspected brain metastases or other distant metastases;
• Participants who received Chinese herbal medicines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory drugs within 2 weeks prior to the first dose of the study drug;
• Participants with a condition requiring systemic treatment with corticosteroids or is receiving any other form of immunosuppressive therapy within 7 days prior the first dose of the study drug;
• History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
• History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
• History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
• Active or uncontrolled diseases or conditions;
• History of immunodeficiency disease;
• Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.

Where it is running

• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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