A Study With Pembrolizumab for Non-small Cell Lung Cancer (NSCLC)

NCT04393883 | Unknown

• 1 other identifier: IR2019001206
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, national multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 3 weeks or 6 weeks in (Non-small-cell-cell cancer, NSCLC) subjects without systematic treatment， who used Pembrolizumab after 6 cycles of combined chemotherapy， estimated with stable efficacy (CR, PR, and SSD) . In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio: (A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year; (B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

Conditions

Non-small-lung-cell Cancer, NSCLC; Pembrolizumab

Keywords

(Non-small-lung-cell cancer, NSCLC) subjects,Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause

  three years

Secondary Outcomes (3)

• objective response rate

  three years

• OS：overall survival

  three years

• Duration of mitigation (DOR)

  three years

Study Arms (2)

Standard maintenance programme group

EXPERIMENTAL

pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;

Drug: A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;

Improvement maintenance programme group,

EXPERIMENTAL

pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

Drug: B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

Interventions

A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year; DRUG

(A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;

Standard maintenance programme group

B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up; DRUG

(B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;

Improvement maintenance programme group,

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures. 2. 18 to 75 years old (with critical values) when signing ICF. 3. Hemology diagnostics of phase IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy. 4. No known EGFR sensitivity mutations or ALK, ROS1 gene rearrangement; 5. Patients have never received systemic treatment throughout the body for phase IV NSCLC. 6. The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss). 7. Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements. 8. Patients must provide the required tumor tissue for PD-L1 expression level determination, and PD-L1 is 1%. Note: Samples of tumor tissue fixed by Formalin within 6 months prior to the first study of the drug use are recommended. Paraffin encapsulated tumor specimens (preferred) or unstained newly cut continuous tissue slices (preferred anti-stripping slides). A relevant pathological report of the above specimen sits must also be provided. Freshly collected specimens, excision, hollow needle core biopsy, excision, cut, stamping or clamp biopsy are all within acceptable range (preferred newly acquired tissue). Needle-absorbing samples (i.e., samples that lack a complete tissue structure only provide cell suspension and/or cell smears), brush samples, cell precipitation samples from chest or celiac fluidares are not accepted. The organization sample requirements are detailed in the laboratory operating manual. 9. The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1. 10. After 6 cycles of combination chemotherapy with Pembrolizumab 200mg Q3W or Pembrolizumab 200mg Q3W immunotherapy, the efficacy was assessed as CR, PR, SD. 11. The expected lifetime is 12 weeks. 12. The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or csphylitosin (CSF) treatment within 14 days prior to the first drug use in this study): 13. Organ function is normal:
• White blood cells s.0 x 109/L
• Absolute Neutlyte Granucyte Count (ANC) s2.0 x 109/L
• Platelet count: 100 x 109/L
• Hemoglobin s 90 g/L
• Creatine s 1.5 x ULN;
• Total bilirubin s 1.5 x ULN (except Gilbert syndrome, total bilirubin 3.0 mg/dL);
• AST (SGOT) is 2.5 x ULN, for patients with liver metastiars, s.5 x ULN;
• ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, s.5 x ULN;
• Alkaline phosphatase is 3 times the normal upper limit;
• Clotting function: activated part of the clotting enzyme time (APTT) s1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) s1.5 x ULN;
• Female patients must meet one of the following:
• (1) menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause); (2) sterilization performed (removal of the ovaries and/or uterus); (3) Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices. 12) Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception.

You may not qualify if:

• \. Histological type is small cell lung cancer or mixed tumors with small cell lung cancer, neuroendocrine cancer components. 2. Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, breast in situ cancer, etc. can be included in the group. 3. A patient who is prepared to undergo or have received an organ or bone marrow transplant in the past. 4. Chest fluid, cardiac fluid or ascites that cannot be controlled by appropriate intervention. 5. Known or screened examinations found in patients with active central nervous system (CNS) metastasis and/or cancerous meningitis. However, the following patients are allowed to join the group: 1) Asymptomatic brain metastasis patients (i.e. no brain metastasis caused by the development of sexual central nervous system symptoms, do not require glucocorticoid therapy, and the size of the lesions of 1.5cm) can participate, but the disease site needs to be regularly examined for brain imaging. 2) In patients with after treatment of brain metastasis, and brain metastasis lesions are stable for at least 1 month, there is no new or enlarged evidence of brain metastasis, and glucocorticoids are discontinued for 3 days before administration. Stable brain metastasis should be determined prior to the first drug use. 6. Surgery and/or radiotherapy fail to cure spinal cord compression. 7. Obviously hemorrhagic, combined patients with venous syndrome. 8. Myocardial infarction and poor control of arrhythmia (including QTc interstitallated men with a period of 450 ms and female s470 ms) occurred in the first six months prior to the first drug use (QTc interstitallator is calculated using the Fridericia formula). 9. In accordance with NYHA Standard III- IV level cardiac insufficiency or cardiac color super-examination: LVEF (left ventricular blood score) 50%. 10. Poor control of hypertension (i.e. systolic pressure (BP) of 150 mmHg and/or diastolic pressure of 100 mmHg), has previously appeared high blood pressure risk or hypertension encephalopathy. 11. The patient had CTCAE 4.03 peripheral neuropathy level 2. 12. Human immunodeficiency virus (HIV) infection. 13. He suffers from active tuberculosis. 14. Past and current patients with interstitial pneumonia, dust lung, radiocopmedy, drug-related pneumonia, severe lung function, etc., may interfere with the monitoring and treatment of suspected drug-related pulmonary toxicity. 15. Patients have known active or suspected autoimmune diseases. Patients who are allowed to be in a stable state and do not require systemic immunosuppressants. 16. Hepatitis B (HBsAg or HBcAb tested positive and HBV-DNA tested positive), hepatitis C (hCV antibody tested positive and HCV-RNA positive). Subjects with a common infection with hepatitis B and C (HBsAg or HBcAb tested positive and HCV antibodies tested positive). 17. A live vaccine is treated within 28 days of the first drug use, but seasonal influenza is permitted, but the detoxified live flu vaccine is not allowed to be administered with nasal medication. 18. Patients who need to be treated with systemic glucocortical extrex (?10 mg/temponnison) or other immunosuppressive medications within 14 days of the first drug use or during the study. However, admission is permitted in the group where patients are allowed to use topical or inhaled glucocorticoids and adrenal corticosteroid replacement therapy at a dose of 10 mg/templiison. 19. Any active infectionthat that requires systemic anti-infection treatment occurs within 14 days of the first drug use. 20. Within 28 days of the first drug use, major surgery was undergone, and the study defined major surgery: at least 3 weeks of recovery time after surgery to be able to undergo surgery for this study. Tumor punctures or lymph node cut biopsies are allowed into the group. 21. Within 3 months of the first drug use, he received thetogenive radiation therapy. Note: Palliative radiotherapy for bone palliative radiotherapy or superficial lesions is permitted, the course of treatment is based on local standards and is completed 2 weeks prior to the first dose. Radiotherapy covering more than 30% of the bone marrow area is not permitted within 28 days of the first use. 22. Patients have previously received other antibodies/drugs against immuno-checking points, such as PD-1, PD-L1, CTLA4, etc. 23. Participating in other clinical studies, or planning to begin treatment for this study is less than 14 days from the end of the previous clinical study. 24. A history of severe allergies to any monoclonal antibody is known. 25. Pregnant or lactating women. 26. Patients are known to have a history of psychotropic substance abuse or drug abuse; 27. The researchers determined that the patient had other factors that might have caused the study to be forced to terminate in the middle.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Sir Run Run Shaw Hospital: collaborator
• Guangzhou Medical University: collaborator
• Southern Medical University, China: collaborator
• Beijing Sino-Japan Friendship Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Changhai Hospital of the Second Military Medical University: collaborator
• Jiangsu People's Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Tongji Hospital: collaborator
• Xijing Hospital Affiliated to the Fourth Military Medical University: collaborator
• Xiangya Hospital of Central South University: collaborator
• West China Hospital: collaborator
• The Second Affiliated Hospital of the Army Medical University (the Third Military Medical University) - Xinqiao Hospital: collaborator
• Zunyi Medical College: collaborator
• The Second Affiliated Hospital of Fujian Medical University: collaborator

Study Sites (1)

Key Laboratory of Respiratory Disease of Zhejiang Province, Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China

Hangzhou, Zhejiang, +86 310018, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Fen Lan

  Fen lan， Kejin Yin, Chenzhi Zhou, Shaoxi Cai, Ting Yang, Gang Hou, Cong Bai, Mao Huang, LIang Dong,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fen Lan

CONTACT

15824446949; whlanfen@126.com

Jiesen Zhou

CONTACT

15258851004; jason.627@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 19, 2020
• Study Start: April 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: November 30, 2020

Record last verified: 2020-04

Locations

CN (1)