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

Innovent Biologics

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Keytruda; Drug: Cisplatin; Drug: IBI363; Drug: Pemetrexed; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07122687

CIBI363C201

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

IBI363

Experimental group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: IBI363

Drug: Cisplatin

Keytruda

Active Comparator group

Description:

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

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Drug: Cisplatin

Drug: Keytruda