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

NCT07408635 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-02-13

No results posted yet for this study

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)

Interventions

DRUG

IBI363 + Chemotherapy

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-07
Primary Completion
2028-06-06
Completion
2030-01-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07408635 on ClinicalTrials.gov