Application of Pablizumab Combined With Apatinib and Chemotherapy in Resectable Non-small Cell Lung Cancer： A Prospective, Single Arm, Single Center Phase II Clinical Study of Neoadjuvant Therapy

NCT04968002 | Unknown Phase 2

• 1 other identifier: 2021-0309
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm, single center clinical study to determine the efficacy and safety of pablizumab combined with apatinib and neoadjuvant chemotherapy in patients with stage iia-iiia non-small cell lung cancer. No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols. The patients were followed up from adjuvant treatment and follow-up to relapse free survival until disease progression, withdrawal of informed consent, loss of follow-up or death.

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer; Pabolizumab

Outcome Measures

Primary Outcomes (1)

• The main pathological response rate

  After neoadjuvant therapy, the residual tumor was observed under microscope with a result of the proportion of tumor cells was less than or equal to 10%.

  through surgical treatment completion, an average of 4 months

Study Arms (1)

Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer.

EXPERIMENTAL

No EGFR mutation or ALK gene translocation was found in the untreated patients with NSCLC stage IIa-IIIb diagnosed by imaging, histopathology or cytology. After informed consent is signed by the patients. The patients were treated according to the protocols.

Drug: pablizumab combined with apatinib and neoadjuvant chemotherapy

Interventions

pablizumab combined with apatinib and neoadjuvant chemotherapy DRUG

The patients with stage IIa-IIIa non-small cell lung cancer are treated with pablizumab combined with apatinib and neoadjuvant chemotherapy

Preoperative neoadjuvant therapy for patients with stage IIa-IIIa non-small cell lung cancer.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Non small cell lung cancer was diagnosed by imaging, histopathology or cytology
• The resectable clinical stage assessed by the investigators was stage IIA - IIIA (according to AJCC)
• TNM staging, 8th Edition);
• \. ECoG PS score: 0-1;
• \. According to the RECIST version 1.1 evaluation standard, at least one image can be measured
• The lesions were measured;
• \. There was no operation contraindication in preoperative organ function examination;
• \. The laboratory examination indexes meet the requirements:
• \. No previous treatment for NSCLC, including surgery and chemotherapy
• Therapy, radiotherapy, targeted therapy, hormone or immunotherapy, etc;
• \. Women of childbearing age agreed to use contraception during the study and within 6 months after the end of the study; study
• The serum or urine pregnancy test was negative in the first seven days, and the patients were not in lactation
• \. The subjects can understand the research situation and sign the informed consent voluntarily.

You may not qualify if:

• Or radiotherapy;
• \. The tumor has invaded important blood vessels or the tumor is in the treatment stage according to the judgment of the researcher
• There is a high possibility of invading important blood vessels and causing massive hemorrhage;
• \. Known EGFR mutation or ALK gene translocation;
• \. There are locally advanced unresectable diseases and metastatic diseases;
• \. She had been suffering from the need to use corticosteroids (prednisolone) in 14 days before randomization
• Daily dose of nisone or equivalent (10 mg) or other immunosuppressive drugs
• Any disease requiring systemic treatment. Local replacement steroids are permitted
• (daily dose ≤ 10 mg of prednisone or equivalent) and prescription corticosteroids
• Short term (≤ 7 days) prophylactic use of alcohol or for the treatment of non autoimmune.
• Any active autoimmune disease or history of autoimmunity;
• \. Active autoimmune diseases or autoimmune diseases that may recur
• History. Admission of well controlled type I diabetes and hormone replacement therapy are allowed.
• Hypothyroidism, well controlled celiac disease, and no need for complete treatment
• Skin diseases (such as vitiligo, psoriasis or alopecia) treated by the body or not

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

apatinib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Gang Shen, master

CONTACT

+86 571 87783641.; 2198022@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 20, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-06

Locations

CN (1)