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

A Phase II Study Evaluating the Efficacy and Safety of IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Stage II-III Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: IBI363

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoqin Ruan; Phone Number: 0512-69566088-8095; Email: xiaoqin.ruan@innoventbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Principal Investigator: Jie Wang
      • Contact: Jie Wang; Phone Number: 010-87788525; Email: wangjie@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and Females, age ≥18 years and ≤75 years;

2. 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.
3. Participants without EGFR mutations or ALK translocation;
4. PD-L1 expression: TPS≥1%
5. At least 1 measurable lesion per RECISIT v1.1;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
7. 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. Clinically significant cardiovascular or cerebrovascular disease , or history of any thromboembolic event within 6 months prior to the first dose of the study drug;
9. 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;
10. Active or uncontrolled diseases or conditions;
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant Therapy; Neoadjuvant therapy period : Subjects will receive IBI363 for up to 4 cycles before surgery	Drug: IBI363; Subjects will receive IBI363 for up to 4 cycles, each cycle is 21 days, the first treatment cycle is 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival (EFS)	EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.	Up to approximately 5 years
Major Pathological Response (mPR) Rate	mPR rate is defined as ≤ 10% 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
Objective Response Rate （ORR）Rate	ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CIBI363C202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No