Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study

Study Overview
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Brief Summary
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To observe and evaluate the efficacy and safety of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC and the relevance with Immune Receptor Repertoire

Official Title
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Monitoring the Efficacy of Duvalizumab Combined With Neoadjuvant Chemotherapy for Ib-IIIb NSCLC by Sequencing of Immune Receptor Repertoire: a Prospective, One Arm Clinical Study

Conditions
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Ib-IIIb NSCLC

Intervention / Treatment
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* Drug: Duvalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: ≥ 18 years old; NSCLC confirmed by histopathology; According to the doctor's advice, according to the routine diagnosis and treatment process, lung cancer patients who need radical resection and neoadjuvant therapy before operation; No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy; ECoG score was 0 or 1; There was no operative contraindication in preoperative organ function examination; At least 6 months of expected survival The laboratory examination met the following standards: Bone marrow function: hemoglobin (HB) ≥ 90g / L; White blood cell count (WBC) ≥ the lower limit of normal value; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L； Platelet count ≥ 90 × 10^9/L； Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min; Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 * ULN); Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range; The subjects agreed and voluntarily signed the informed consent Exclusion Criteria: Allergic to the study drug; History of hemorrhagic disease or with hemorrhagic disease Liver and kidney dysfunction; Patients with uncontrolled diseases (including but not limited to: active infection, symptomatic congestive heart failure; Myocardial infarction occurred within 3 months; Unstable angina, arrhythmia, etc.); Women of childbearing age are unwilling to use contraception; Lactating women; For any other reason, the researchers consider it inappropriate to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duvalizumab Combined With Neoadjuvant Chemotherapy<br> | Drug: Duvalizumab<br>* Pemetrexed 850 mg, IV, Day1; Platinum 50mg / m2, IV, day1, once every 3 weeks, duvalizumab treatment, 1500mg, day1, a total of 4 cycles, once every 3 weeks. 4 cycles in total<br>* Other names: platinum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate | at 64th week | 
| DFS | disease free survival | at 64th week |