IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

NCT07402070 | Not Yet Recruiting Phase 2

• 1 other identifier: CIBI363C202
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2 study to evaluate the safety, and efficacy of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer.

Conditions

Resectable Stage II-III 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 Treatment-related Adverse Event, (TRAEs)

  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 (1)

Neoadjuvant Therapy

EXPERIMENTAL

Neoadjuvant therapy period : Subjects will receive IBI363 for up to 4 cycles before surgery

Drug: IBI363

Interventions

IBI363 DRUG

Subjects will receive IBI363 for up to 4 cycles, each cycle is 21 days, the first treatment cycle is 28 days

Neoadjuvant Therapy

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 NSCLC:
• Stage 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;
• PD-L1 expression: TPS≥1%
• 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;
• Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug;
• History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or severe impairment of pulmonary function or who are suspected to have these diseases by imaging during the screening period;
• Active or uncontrolled diseases or conditions;
• History of immunodeficiency disease; 12 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)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Central Study Contacts

Xiaoqin Ruan

CONTACT

0512-69566088-8095; xiaoqin.ruan@innoventbio.com

Study Design

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

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 11, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CN (1)