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

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

Inclusion Criteria:

1. Males and Females, age ≥18 years and ≤75 years;
2. 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.
3. Participants without EGFR mutations or ALK translocation;
4. At least 1 measurable lesion per RECISIT v1.1;
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
6. Adequate organ function confirmed at screening period.

Exclusion Criteria:

1. 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;
2. Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated;
3. Pancoast tumor;
4. Malignant tumor nodule in the contralateral lung lobe;
5. Participants with known or suspected brain metastases or other distant metastases;
6. 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;
7. 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;
8. History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
9. History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
10. 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;
11. Active or uncontrolled diseases or conditions;
12. History of immunodeficiency disease;
13. Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.

Conditions3

Interventions5

Related trials

• A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors — CStone Pharmaceuticals
• A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors — Mabwell (Shanghai) Bioscience Co., Ltd.
• A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lung Cancer — Shanghai Jiao Tong University School of Medicine
• A Single-center Phase II Study to Investigate the Immune Maintenance Therapy Pattern in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Who Have Achieved MPR After Neoadjuvant Immunotherapy Combined With Chemotherapy — Tianjin Medical University Cancer Institute and Hospital
• A Study of Adebrelimab in Combination With Apatinib Gemcitabine and Cisplatin in Biliary Tract Malignancies — First Affiliated Hospital of Fujian Medical University
• A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC — Sichuan Baili Pharmaceutical Co., Ltd.
• A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma — Renmin Hospital of Wuhan University
• A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer — Peking University Cancer Hospital & Institute

Browse More Trials