Tests IBI363 with chemotherapy before surgery for early lung cancer
Compares IBI363 plus chemotherapy with Keytruda plus chemotherapy in adults with operable non-squamous lung cancer.
Key facts
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Where
- Shenyang, ChinaSee the site
- Trial code
- Registry title
- IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 170 people, planned
- Started
- 26 Aug 2025
- Expected to end
- 30 Apr 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Pemetrexed
- Cisplatin
- IBI363
- Carboplatin
- Keytruda
- Record updated
- 27 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-squamous non-small cell lung cancer (stage IB to III) that can be removed by surgery and has not been treated yet. It compares two treatments given before surgery.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Non-squamous non-small cell lung cancer, stage IB, II, IIIA or IIIB (N2), that can be removed by radical surgery. At least 1 measurable tumour (RECIST v1.1). ECOG performance status 0-1.
- Earlier treatment
- No anti-lung-cancer treatment before the operation.
- Biomarker or test result
- No EGFR mutation and no ALK translocation.
Main reasons for not taking part
- Small cell, neuroendocrine or mainly squamous cell lung cancer
- Known or suspected brain or other distant metastases
- Steroid or other immunosuppressive treatment in the last 7 days
- Active autoimmune disease needing systemic treatment in the last 2 years
- History of immunodeficiency disease
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Participants with active autoimmune disease requiring systemic treatment within 2 years prior to the first dose of the study drug
- 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
- Malignant tumor nodule in the contralateral lung lobe
- 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
- Tumor invasion of surrounding important structures, which is symptomatic or medical intervention indicated
- Pancoast tumor
- Participants with known or suspected brain metastases or other distant metastases
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Liaoning Cancer Hospital and InstituteShenyang, ChinaContact: Hongxu LiuTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- IBI363Treatment being tested
Neoadjuvant Treatment period: 4 cycles of IBI363 plus platinum-based chemotherapy prior to surgery.
Treatment: Pemetrexed, Cisplatin, IBI363, and Carboplatin
- KeytrudaExisting treatment, for comparison
Neoadjuvant Treatment period: 4 cycles of Keytruda plus platinum-based chemotherapy prior to surgery.
Treatment: Pemetrexed, Cisplatin, Carboplatin, and Keytruda
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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
- Plain-language title
- Tests IBI363 with chemotherapy before surgery for early lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07122687, who can take part
- Record updated
- 27 July 2026