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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03830411
Other study ID # CTGU002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 13, 2019
Est. completion date June 30, 2022

Study information

Verified date November 2021
Source China Three Gorges University, Yichang, China
Contact Xinhua Xu, Master
Phone +8613986747496
Email 2732774352@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sintilimab
Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Docetaxel
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
Pemetrexed
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.

Locations

Country Name City State
China Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University Yichang Hubei

Sponsors (1)

Lead Sponsor Collaborator
Xin-Hua Xu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (OS) 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. Approximately 21 months
Secondary Objective Response Rate (ORR) 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. Approximately 21 months
Secondary Progression-free survival (PFS) 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. Approximately 21 months
Secondary Duration of response (DOR) 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. Approximately 21 months
Secondary Emergence of adverse events(AEs) AEs graded using CTCAE (Version 4.0) criteria. Approximately 21 months
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Recruiting NCT03863483 - 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. Phase 2
Active, not recruiting NCT03829319 - Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006) Phase 3
Active, not recruiting NCT05338970 - HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy Phase 3
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