Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pemetrexed, Cisplatin, IBI363, Carboplatin.
- Who it may be relevant to
- Registry conditions: Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Pemetrexed
500 mg/m2 D1 IV Q3W - Drug Cisplatin
75 mg/m2 D1 IV Q3W - Drug IBI363
1.5 mg/kg D1 IV Q3W - Drug Carboplatin
AUC 5 mg/ml/min D1 IV Q3W - Drug Keytruda
200mg D1 IV Q3W
Primary outcome measures
- Pathologic Complete Response (pCR) rate [Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment]
- Safety parameters: the incidence of all adverse events (AEs) [Time frame: up to 90 days after the last dose]
- Safety parameters: the incidence of treatment-emergent adverse events (TEAEs) [Time frame: up to 90 days after the last dose]
- Safety parameters: the incidence of immune-related adverse events (irAEs) [Time frame: up to 90 days after the last dose]
- Safety parameters: the incidence of adverse events of special interest (AESIs) [Time frame: up to 90 days after the last dose]
- Safety parameters: the incidence of serious adverse events (SAE) [Time frame: up to 90 days after the last dose]
- 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]
- Safety parameters: the surgery delay rate [Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment]
- 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 outcome measures (5)
- Event Free Survival (EFS) [Time frame: Up to approximately 5 years]
- Major Pathological Response (mPR) Rate [Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment]
- Objective Response Rate （ORR）Rate [Time frame: Up to approximately 5 years]
- Disease Control Rate (DCR) Rate [Time frame: Up to approximately 5 years]
- R0 resection rate [Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Liaoning Cancer Hospital and Institute — Shenyang
Identifiers
NCT: NCT07122687 · CIBI363C201