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

Phase 2

Not yet recruiting

• Conditions: Ib-IIIb NSCLC
• Interventions: Drug: Duvalizumab

• Registration Number: NCT04897386
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-20
• Last Update Submitted: 2021-05-20
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21
• Study Start: 2021-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duvalizumab Combined With Neoadjuvant Chemotherapy	Duvalizumab	-

Primary Outcome Measures

Name	Time	Method
ORR	at 64th week	Objective response rate
DFS	at 64th week	disease free survival