A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03830411|
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nonsquamous Non-Small Cell Lung Cancer||Drug: Sintilimab Drug: Docetaxel Drug: Pemetrexed||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Prospective, Single-center, Randomized, Controlled Study to Investigate 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.|
|Actual Study Start Date :||March 13, 2019|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Arm A: Sintilimab
Participants will receive Sintilimab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
Other Name: IBI308
Active Comparator: Arm B: Chemotherapy (Docetaxel or Pemetrexed)
Participants randomized to the chemotherapy arm will receive docetaxel or pemetrexed until disease progression per standard RECIST v1.1 or unacceptable toxicity.
Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
- Overall Survival (OS) [ Time Frame: Approximately 21 months ]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.
- Objective Response Rate (ORR) [ Time Frame: Approximately 21 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.
- Progression-free survival (PFS) [ Time Frame: Approximately 21 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.
- Duration of response (DOR) [ Time Frame: Approximately 21 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.
- Emergence of adverse events(AEs) [ Time Frame: Approximately 21 months ]AEs graded using CTCAE (Version 4.0) criteria.
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): NCT03830411
|Contact: Xinhua Xu, Master||+8613986747496 ext +email@example.com|
|Contact: Yan Wang, Master||+8615997550081 ext +firstname.lastname@example.org|
|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 email@example.com|