IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Ther… (NCT07122687) | Clinical Trial Compass
RecruitingPhase 2
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
China170 participantsStarted 2025-08-26
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and Females, age ≥18 years and ≤75 years;
. Histologically or cytologically confirmed primary non-squamous NSCLC:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic Complete Response (pCR) rate
Timeframe: Up to approximately 8 weeks following completion of neoadjuvant treatment
2
Safety parameters: the incidence of all adverse events (AEs)
Timeframe: up to 90 days after the last dose
3
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
Timeframe: up to 90 days after the last dose
4
Safety parameters: the incidence of immune-related adverse events (irAEs)
Timeframe: up to 90 days after the last dose
5
Safety parameters: the incidence of adverse events of special interest (AESIs)
Timeframe: up to 90 days after the last dose
6
Safety parameters: the incidence of serious adverse events (SAE)
Timeframe: 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
. 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;
Timeframe: up to 90 days after the last dose
8
Safety parameters: the surgery delay rate
Timeframe: 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