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

Huazhong University of Science and Technology

Status and phase: Not yet enrolling; Phase 2

Conditions: Ib-IIIb NSCLC

Treatments: Drug: Duvalizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04897386

duvalizumab

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: ≥ 18 years old;

2. NSCLC confirmed by histopathology;

3. 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;

4. No previous treatment for esophageal cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, hormone or immunotherapy;

5. ECoG score was 0 or 1;

6. There was no operative contraindication in preoperative organ function examination;

7. At least 6 months of expected survival

8. The laboratory examination met the following standards:

   1. 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；
   2. Renal function: Cr ≤ unl (upper limit of normal value) × 5, CCR ≥ 55ml / min;
   3. Liver function: total bilirubin ≤ ULN × 1.5； ALT and AST ≤ ULN × 2.5 (patients with liver metastasis can be relaxed to ≤ 5 * ULN);
   4. Coagulation function: international normalized ratio of prothrombin time ≤ ULN × 5, and partial thromboplastin time was within the normal range;

9. The subjects agreed and voluntarily signed the informed consent

Exclusion criteria

1. Allergic to the study drug;
2. History of hemorrhagic disease or with hemorrhagic disease
3. Liver and kidney dysfunction;
4. 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.);
5. Women of childbearing age are unwilling to use contraception;
6. Lactating women;
7. For any other reason, the researchers consider it inappropriate to participate in the trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Duvalizumab Combined With Neoadjuvant Chemotherapy

Experimental group

Treatment:

Drug: Duvalizumab