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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: pablizumab combined with apatinib and neoadjuvant chemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Gang Shen, master; Phone Number: +86 571 87783641.; Email: 2198022@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Gang Shen, master; Phone Number: +86 571 87783641.; Email: 2198022@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:1. Age: 18-75 years old, male or female;

2. 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);

3. ECoG PS score: 0-1;

4. According to the RECIST version 1.1 evaluation standard, at least one image can be measured

The lesions were measured;

5. There was no operation contraindication in preoperative organ function examination;

6. The laboratory examination indexes meet the requirements:

7. No previous treatment for NSCLC, including surgery and chemotherapy

Therapy, radiotherapy, targeted therapy, hormone or immunotherapy, etc;

8. 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

9. The subjects can understand the research situation and sign the informed consent voluntarily.

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Exclusion Criteria: 1. Have received any treatment including chemotherapy in the past

Or radiotherapy;

2. 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;

3. Known EGFR mutation or ALK gene translocation;

4. There are locally advanced unresectable diseases and metastatic diseases;

5. 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;

6. 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

Due to the absence of recurrence of the disease is not expected.

7. Interstitial lung disease, non infectious pneumonia or poorly controlled diseases (including pulmonary fibrosis)

History of vitamin C, acute lung disease, etc.

8. active hepatitis B (defined as screening hepatitis B virus surface antigen [HBsAg])

The results were positive and HBV-DNA was detected. The detection value was higher than that in the study

Upper limit of normal value of cardiology laboratory) or hepatitis C (defined as screening hepatitis C virus table)

The subjects with positive results of hcsab and HCV-RNA;

9. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);

10. Inoculate live vaccine within 30 days before the first administration. Including but not limited to the following:

Mumps, rubella, measles, varicella / herpes zoster (varicella), yellow fever

Rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed);

11. Suffering from uncontrolled clinical symptoms or diseases of the heart;

12. Long term antiplatelet therapy is needed;

13. Those who are allergic to any drug in this program;

14. Pregnant or lactating women;

15. According to the judgment of the researcher, the subjects may confuse the test results and interfere

It is not in the best interests of the subjects to participate in the whole trial

A history or current evidence of any disease, treatment, or laboratory abnormality

It's a good idea.

16. Active bleeding.

Exclusion criterion:

1. Ever received any treatment including chemotherapy or radiotherapy in the past;
2. The tumor has invaded important blood vessels. There is a high possibility of invading important blood vessels and causing massive hemorrhage if the tumor is in the treatment stage process according to the judgment of the researcher;
3. EGFR mutation or ALK gene translocation;
4. There are locally advanced unresectable diseases and metastatic diseases;
5. Patients had been suffering from the need to use corticosteroids (prednisolone) in 14 days before randomization grouping. Daily dose of nisone or equivalent (10 mg) or other immunosuppressive drugs. Any active autoimmune disease or history of autoimmunity;
6. Active autoimmune diseases or autoimmune diseases that may recur
7. Interstitial lung disease, non infectious pneumonia or poorly controlled diseases (including pulmonary fibrosis) etc.
8. active hepatitis B (defined as screening hepatitis B virus surface antigen [HBsAg]). And the results were positive and HBV-DNA was detected. The detection value was higher than that in the study upper limit of normal value of cardiology laboratory) or hepatitis C (defined as screening hepatitis C virus table and the subjects with positive results of hcsab and HCV-RNA;
9. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
10. Inoculated live vaccine within 30 days before the first administration. Including but not limited to the following: Mumps, rubella, measles, varicella / herpes zoster (varicella), yellow fever Rabies, BCG and typhoid vaccine (inactivated virus vaccine allowed);
11. Suffering from uncontrolled clinical symptoms or diseases of the heart;
12. Long term antiplatelet therapy is needed;
13. Those who are allergic to any drug in this program;
14. Pregnant or lactating women.;
15. According to the judgment of the researcher, the subjects may confuse and interfere the test results. It is not in the best interests of the subjects to participate in the whole trial.
16. Active bleeding patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Preoperative neoadjuvant therapy for 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.	Drug: pablizumab combined with apatinib and neoadjuvant chemotherapy; The patients with stage IIa-IIIa non-small cell lung cancer are treated with pablizumab combined with apatinib and neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (ACTUAL): July 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; Pabolizumab
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: 2021-0309

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No