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

NCT07122687 | Recruiting Phase 2

• 1 other identifier: CIBI363C201
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Pathologic Complete Response (pCR) rate

  pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

  Up to approximately 8 weeks following completion of neoadjuvant treatment

• Safety parameters: the incidence of all adverse events (AEs)

  up to 90 days after the last dose

• Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)

  up to 90 days after the last dose

• Safety parameters: the incidence of immune-related adverse events (irAEs)

  up to 90 days after the last dose

• Safety parameters: the incidence of adverse events of special interest (AESIs)

  up to 90 days after the last dose

• Safety parameters: the incidence of serious adverse events (SAE)

  up to 90 days after the last dose

• Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity

  up to 90 days after the last dose

• Safety parameters: the surgery delay rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment

• Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests，ECG, etc

  up to 90 days after the last dose

Secondary Outcomes (5)

• Event Free Survival (EFS)

  Up to approximately 5 years

• Major Pathological Response (mPR) Rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment

• Objective Response Rate （ORR）Rate

  Up to approximately 5 years

• Disease Control Rate (DCR) Rate

  Up to approximately 5 years

• R0 resection rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment

Study Arms (2)

IBI363

EXPERIMENTAL

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

Drug: Pemetrexed; Drug: Cisplatin; Drug: IBI363; Drug: Carboplatin

Keytruda

ACTIVE COMPARATOR

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

Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Keytruda

Interventions

Pemetrexed DRUG

500 mg/m2 D1 IV Q3W

IBI363; Keytruda

Cisplatin DRUG

75 mg/m2 D1 IV Q3W

IBI363; Keytruda

IBI363 DRUG

1.5 mg/kg D1 IV Q3W

IBI363

Carboplatin DRUG

AUC 5 mg/ml/min D1 IV Q3W

IBI363; Keytruda

Keytruda DRUG

200mg D1 IV Q3W

Keytruda

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 RECISIT 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Cisplatin; Carboplatin; pembrolizumab

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Central Study Contacts

wei zhang

CONTACT

15005136320; wei.zhang02@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: August 14, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 30, 2030
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (1)