RecruitingPhase 2NCT07122687

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

A Phase II Study Evaluating 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


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

170 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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 RECISIT v1.1;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
  • Adequate organ function confirmed at screening period.

Exclusion Criteria13

  • 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.

Interventions

DRUGPemetrexed

500 mg/m2 D1 IV Q3W

DRUGCisplatin

75 mg/m2 D1 IV Q3W

DRUGIBI363

1.5 mg/kg D1 IV Q3W

DRUGCarboplatin

AUC 5 mg/ml/min D1 IV Q3W

DRUGKeytruda

200mg D1 IV Q3W


Locations(1)

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07122687