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

NCT ID: NCT07122687

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2030-04-30

Brief 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.

Conditions

Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI363

Neoadjuvant Treatment period: up to 3 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

500 mg/m2 D1 IV Q3W

Cisplatin

Intervention Type: DRUG

75 mg/m2 D1 IV Q3W

IBI363

Intervention Type: DRUG

1.5 mg/kg D1 IV Q3W

Carboplatin

Intervention Type: DRUG

AUC 5 mg/ml/min D1 IV Q3W

Keytruda

Neoadjuvant Treatment period: up to 3 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.

Group Type: ACTIVE_COMPARATOR

Pemetrexed

Intervention Type: DRUG

500 mg/m2 D1 IV Q3W

Cisplatin

Intervention Type: DRUG

75 mg/m2 D1 IV Q3W

Carboplatin

Intervention Type: DRUG

AUC 5 mg/ml/min D1 IV Q3W

Keytruda

Intervention Type: DRUG

200mg D1 IV Q3W

Interventions

Pemetrexed

500 mg/m2 D1 IV Q3W

Intervention Type: DRUG

Cisplatin

75 mg/m2 D1 IV Q3W

Intervention Type: DRUG

IBI363

1.5 mg/kg D1 IV Q3W

Intervention Type: DRUG

Carboplatin

AUC 5 mg/ml/min D1 IV Q3W

Intervention Type: DRUG

Keytruda

200mg D1 IV Q3W

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei zhang

Role: CONTACT

wei.zhang02@innoventbio.com

15005136320

Facility Contacts

Hongxu Liu

Role: primary

hongxuliu@qq.com

024-81916272

Other Identifiers

CIBI363C201

Identifier Type: -

Identifier Source: org_study_id