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A Study of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.

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ClinicalTrials.gov Identifier: NCT03863483
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Xin-Hua Xu, China Three Gorges University, Yichang, China

Brief Summary:
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Condition or disease Intervention/treatment Phase
Nonsquamous Non-Small Cell Lung Cancer Drug: Sintilimab Drug: Docetaxel Drug: Pemetrexed Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate the Efficacy and Safety of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Sintilimab plus chemotherapy
Sintilimab (200 mg) plus chemotherapy (physicians' choice between docetaxel and pemetrexed) every 3 weeks.
Drug: Sintilimab
Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.

Drug: Docetaxel
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Active Comparator: Placebo plus chemotherapy
Placebo plus chemotherapy (physicians' choice between docetaxel and pemetrexed) every 3 weeks.
Drug: Docetaxel
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Drug: Placebo
0.9% sodium chloride injection as placebo will be administered intravenously at a fixed dose of 100 milliliters (mL) on Day 1 of each 21-day cycle.




Primary Outcome Measures :
  1. Compare Overall Survival (OS) between sintilimab +chemotherapy and placebo + chemotherapy. [ Time Frame: approximately 24 months ]
    To compare the efficacy of the combination of sintilimab and chemotherapy versus placebo and chemotherapy in terms of overall survival (OS) in patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.


Secondary Outcome Measures :
  1. Compare objective response rate between sintilimab +chemotherapy and placebo + chemotherapy. [ Time Frame: approximately 24 months ]
    ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria.

  2. Compare Progression Free Survival (PFS) between sintilimab +chemotherapy and placebo + chemotherapy using RECIST 1.1. [ Time Frame: approximately 24 months ]
    PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.

  3. Compare duration of response between sintilimab +chemotherapy and placebo + chemotherapy. [ Time Frame: approximately 24 months ]
    DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.

  4. Number of Participants who Experience Treatment Related Adverse Events (AEs). [ Time Frame: approximately 24 months ]
    All Adverse Events and Serious Adverse events will be collected and collated according to grade and frequency. AEs graded using CTCAE (Version 4.0) criteria.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;
  2. Age ≥ 18 years old and ≤ 75 years old, either sex;
  3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
  4. Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;
  5. Have at least one measurable lesion as defined by RECIST 1.1;
  6. Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;
  7. Patients without activating EGFR mutation;
  8. Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;
  9. Normal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );
  10. Normal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];
  11. Has a life expectancy of at ≥3 months.

Exclusion Criteria:

  1. ECOG PS >2;
  2. Small cell lung cancer and squamous NSCLC;
  3. EGFR mutation or mutation status unknown;
  4. Known hypersensitivity or allergy to monoclonal antibody;
  5. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways);
  6. Active autoimmune disease, or a documented history of autoimmune disease;
  7. Treatment with systemic corticosteroids (prednisone≥10mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose;
  8. Known history or active human immunodeficiency virus (HIV);
  9. Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection;
  10. Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment;
  11. Active or poorly controlled severe infection;
  12. Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization;
  13. Received thoracic radiation therapy of >30 Gy within 6 months prior to first dose of study drug;
  14. Completed palliative radiotherapy within 7 days prior to first dose of study drug;
  15. Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863483


Contacts
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Contact: Xinhua Xu, Master +8613986747496 ext +8613986747496 2732774352@qq.com
Contact: Yan Wang, Master +8615997550081 ext +8615997550081 wangyan82033@163.com

Locations
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China, Hubei
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University Recruiting
Yichang, Hubei, China, 443003
Contact: Xinhua Xu    +8613986747496 ext +8613986747496    2732774352@qq.com   
Sponsors and Collaborators
Xin-Hua Xu

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Responsible Party: Xin-Hua Xu, professor, China Three Gorges University, Yichang, China
ClinicalTrials.gov Identifier: NCT03863483     History of Changes
Other Study ID Numbers: CTGU1902
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors