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NCT Number: NCT07122687

IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110000, China

Location status: Recruiting

Location contact

Hongxu Liu

CONTACT

[email protected]

024-81916272

Hongxu Liu

PRINCIPAL_INVESTIGATOR

Jianxing He

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females, age ≥18 years and ≤75 years;
  • Histologically or cytologically confirmed primary non-squamous NSCLC:
  • Stage IB, 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;
  • At least 1 measurable lesion per RECIST v1.1;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
  • Adequate organ function confirmed at screening period.

Exclusion criteria

  • 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;
  • History of any arterial thromboembolic event within 6 months prior to the first dose of the study drug;
  • History of deep vein thrombosis, pulmonary embolism, or any other serious venous thromboembolism within 3 months prior to the first dose of study drug;
  • History of pneumonitis requiring corticosteroid therapy, or history of clinically significant lung diseases or who are suspected to have these diseases by imaging during the screening period;
  • Active or uncontrolled diseases or conditions;
  • History of immunodeficiency disease;
  • Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug.

Treatment and study plan

Pemetrexed

Drug

500 mg/m2 D1 IV Q3W

Cisplatin

Drug

75 mg/m2 D1 IV Q3W

IBI363

Drug

1.5 mg/kg D1 IV Q3W

carboplatin

Drug

AUC 5 mg/ml/min D1 IV Q3W

Keytruda

Drug

200mg D1 IV Q3W

Primary outcomes

  1. Pathologic Complete Response (pCR) rate

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

    pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

  2. Safety parameters: the incidence of all adverse events (AEs)

    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)

    Time frame: Up to approximately 5 years

    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.

  2. Major Pathological Response (mPR) Rate

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

    mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.

  3. Objective Response Rate (ORR)Rate

    Time frame: Up to approximately 5 years

    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.

  4. Disease Control Rate (DCR) Rate

    Time frame: Up to approximately 5 years

    ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease(SD) according to the RECIST v1.1 criteria.

  5. R0 resection rate

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

    R0 resection rate is defined as negative margins, systematic lymph node dissection or sampling, and tumor-negative highest mediastinal lymph nodes.

Study contacts

Contact information is provided by the study sponsor or research team.

xiao zhang

CONTACT

[email protected]

17631117415

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Aug 14, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.