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Not yet recruitingNCT07402070Updated Feb 11, 2026

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

A Phase 2 interventional study of IBI363 in Resectable Stage II-III Non-small Cell Lung Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Resectable Stage II-III Non-small Cell Lung Cancer
03

In context

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Neoadjuvant Therapy

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

    Drug: IBI363

Interventions

  • DrugIBI363

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment

  2. Safety parameters: the incidence of Treatment-related Adverse Event, (TRAEs)

    Time frame: up to 90 days after the last dose

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

    Time frame: up to 90 days after the last dose

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

    Time frame: up to 90 days after the last dose

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

    Time frame: up to 90 days after the last dose

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

    Time frame: up to 90 days after the last dose

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

    Time frame: up to 90 days after the last dose

  8. Safety parameters: the surgery delay rate

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment

  9. 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

    Time frame: up to 90 days after the last dose

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 5 years

  2. 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.

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment

  3. 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.

    Time frame: Up to approximately 5 years

  4. Disease Control Rate (DCR) Rate

    Time frame: Up to approximately 5 years

  5. R0 resection rate

    Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment

07

Study locations

1 site
  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality 100021, China
    • Jie Wang · Contact · wangjie@yahoo.com · 010-87788525
    • Jie Wang · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07402070
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Feb 11, 2026
Start date
Feb 4, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Feb 11, 2026

Study contacts

Xiaoqin Ruan
Contact
xiaoqin.ruan@innoventbio.com
0512-69566088-8095

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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