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

NCT ID: NCT04897386

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-12-01

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

Conditions

Ib-IIIb NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duvalizumab Combined With Neoadjuvant Chemotherapy

Group Type: EXPERIMENTAL

Duvalizumab

Intervention Type: DRUG

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

Interventions

Duvalizumab

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

Intervention Type: DRUG

Other Intervention Names

Pemetrexed; platinum

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaorong Dong

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiaorong Dong, PhD

Role: CONTACT

xiaorongdong@hust.edu.cn

027-85872859

Other Identifiers

duvalizumab

Identifier Type: -

Identifier Source: org_study_id