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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04968002
• Other study ID #: 2021-0309
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Gang Shen, master
• Phone: +86 571 87783641.
• Email: 2198022[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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