IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

NCT07408635 | Recruiting Phase 2

• 1 other identifier: STAR-017
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, phase II clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a neoadjuvant treatment of non-small cell lung cancer.

Conditions

Unresectable Stage III Non-small Cell Lung Cancer; Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• R0 Rate

  The proportion of subjects who underwent lung cancer resection and achieved complete resection (R0) among those receiving IBI363 combined chemotherapy conversion therapy.

  about 4 months after enrollment

Secondary Outcomes (7)

• MPR Rate

  about 5 months after enrollment

• pCR Rate

  about 5 months after enrollment

• Tumor Downstaging Rate

  up to 4 months

• Overall Response Rate (ORR)

  12 weeks

• 2-Year EFS Rate

  up to 2 years

Study Arms (1)

IBI363 + Chemotherapy

EXPERIMENTAL

1. Neoadjuvant therapy phase: IBI363 combined with platinum-based chemotherapy. 2. Surgery phase: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.

Drug: IBI363 + Chemotherapy

Interventions

IBI363 + Chemotherapy DRUG

1. Neoadjuvant treatment: IBI363 combined with platinum-based chemotherapy. 2. Multidisciplinary team(MDT) assessment: Participants deemed operable by the MDT will undergo surgery, and then can continue to receive standard adjuvant therapy for one year. If the NSCLC remained unresectable, concurrent chemoradiotherapy was administered followed by immune checkpoint inhibitor consolidation therapy to maintain.

IBI363 + Chemotherapy

Eligibility Criteria

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

You may qualify if:

• The patient shall sign the informed consent.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Histologically or cytologically confirmed Stage III (per AJCC 9th) squamous or non-squamous non-small-cell lung cancer (NSCLC) deemed unresectable by the investigator.
• Tumours with mixed NSCLC histology must be categorised as either squamous or non-squamous on the basis of the predominant component. Tumours containing both NSCLC and small-cell lung cancer (SCLC) are excluded.
• "Unresectable" is defined as following: (1) Multistation or confluent metastasis in ipsilateral mediastinal lymph nodes (2)Contralateral or supraclavicular lymph node metastasis (N3) (3)Invasion of critical organs or major blood vessels (4)Extensive invasion of the chest wall and pleura (5)Special anatomical locations (6）Patient intolerance to lobectomy or pneumonectomy.
• At least one measurable lesion per RECIST v1.1.
• Adequate organ function meet the following standards (within 14 days before first dose, any blood components or growth factor drugs is not permitted):
• ANC count ≥ 1.5 × 10⁹/L
• Platelet count ≥ 100 × 10⁹/L
• Hemoglobin ≥ 90 g/L
• Serum Cr ≤ 1.5 times of upper limit of normal (ULN) or calculated creatinine clearance (CLcr) ≥ 50 mL/min
• Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in Gilbert's syndrome)
• AST and ALT ≤ 2.5 × ULN
• INR or APPT ≤ 1.5 × ULN

You may not qualify if:

• Non-squamous and squamous NSCLC with EGFR active mutation positive, ALK rearrangement, or any other driver mutation with an approved targeted therapy.
• History of other malignant tumors within five years or concurrently present, except adequately treated cervical carcinoma in situ, basal- or squamous-cell skin carcinoma, localized prostate cancer after radical prostatectomy, ductal carcinoma in situ after radical prostatectomy, or other tumor deemed cured by the investigator.
• Histologically confirmed the presence of small cell lung cancer component.
• Participants who have received any systemic anti-cancer treatment.
• Clinically significant cardiovascular or cerebrovascular disease, including:
• Myocardial infarction or unstable angina within 6 months before first dose
• Stroke or transient ischaemic attack within 6 months before first dose
• Uncontrolled hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 100 mmHg) despite optimal therapy
• Congestive heart failure (NYHA class III-IV)
• Myocarditis
• Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \>10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy are permitted.
• Presence of any active autoimmune disease or history of autoimmune disease.
• Idiopathic pulmonary fibrosis, organizing pneumonia, drug pneumonia, or active pneumonia shown on CT during screening period have been or are currently present.
• History of allogeneic haematopoietic stem-cell or solid-organ transplantation.
• The subject has congenital or acquired immune deficiency (such as HIV infected persons).

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Chang Chen, MD

CONTACT

+86 21 65115006; changchenc@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 13, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): January 6, 2030
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CN (1)