- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04252365
Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer
A Randomized Controlled, Phase II Trial Comparing Sintilimab and Pembrolizumab at First-line Setting in Patients With Advanced Non-small Cell Lung Cancer
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yi-Long Wu
- Phone Number: +86 13809775415
- Email: syylwu@live.cn
Study Contact Backup
- Name: Qing Zhou
- Phone Number: +86 13544561166
- Email: gzzhouqing@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥18 years. Signed Informed Consent Form.
- Stage IV NSCLC confirmed by histology/ cytology or Stage IIIB-IIIC NSCLC that could not be treated with radical radiation therapy (8th edition of IASLC Lung Cancer Staging System).
- Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory.
- Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed.
- Per RECIST 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy.
- Patients who received no systemic chemotherapy or any other systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
Exclusion Criteria:
- Active hepatitis B. Active hepatitis B is defined as HBsAg positive and the detected HBV-DNA copy number is larger than the upper limit of normal value in the laboratory of the study site.
- Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required.
- Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment.
- Active tuberculosis. Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension [CTCAE Grade 2 hypertension or above after drug treatment]).
- Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: arm 1
Patients with PD-L1 high expression (TPS≥50%) receive Sintilimab injection 200mg i.v. on day 1 every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Sintilimab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Sintilimab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. |
Given i.v.
Other Names:
|
ACTIVE_COMPARATOR: arm 2
Patients with PD-L1 high expression (TPS≥50%) receive Pembrolizumab injection 200mg i.v. on day 1once every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. Patients with PD-L1 low or negative expression (TPS<50%) receive Pembrolizumab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Pembrolizumab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity. |
Given i.v.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Up to 3 years
|
Defined as the percentage of patients whose tumors have a complete or partial response to treatment
|
Up to 3 years
|
Collaborators and Investigators
Investigators
- Study Chair: Yi-Long Wu, Guangdong Association of Clinical Trials, GACT
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTONG1901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nsclc
-
Xinqiao Hospital of ChongqingCompleted
-
Seoul St. Mary's HospitalBoehringer IngelheimActive, not recruiting
-
Taipei Veterans General Hospital, TaiwanNational Taiwan University Hospital; China Medical University Hospital; Tri-Service... and other collaboratorsUnknown
-
AstraZenecaCompletedNSCLCSweden, Bulgaria, Mexico, Russian Federation, Turkey, United Kingdom, Philippines, Malaysia, Germany, Hungary, Latvia, Lithuania, Poland, Romania, Netherlands, Norway, Argentina, Australia, Canada, Slovakia, Greece, Taiwan, Thailand, ... and more
-
Shanghai Henlius BiotechNot yet recruiting
-
The Netherlands Cancer InstituteEnrolling by invitation
-
Centre Oscar LambretUniversity Hospital, LilleTerminated
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdCompleted
-
Bio-Thera SolutionsCompleted
Clinical Trials on Sintilimab
-
Beijing Tiantan HospitalRecruiting
-
RemeGen Co., Ltd.Recruiting
-
Innovent Biologics (Suzhou) Co. Ltd.CompletedAdvanced or Metastatic NSCLCChina
-
Innovent Biologics (Suzhou) Co. Ltd.Innovent Biologics (USA), Inc.WithdrawnMetastatic Cutaneous Melanoma | Unresectable Cutaneous MelanomaUnited States, Germany, France, Australia, Spain, Switzerland, United Kingdom
-
Shanghai YingLi Pharmaceutical Co. Ltd.RecruitingAdvanced Solid TumorsChina
-
Zhejiang Cancer HospitalRecruitingEsophageal Squamous Cell CarcinomaChina
-
Peking Union Medical College HospitalRecruiting
-
The First Hospital of Jilin UniversityActive, not recruitingLocally Advanced Rectal Cancer | PD-1 | Total Neoadjuvant Treatment | TislelizumabChina
-
Innovent Biologics (Suzhou) Co. Ltd.Completed
-
Wuhan UniversityRecruitingEsophageal Squamous Cell CarcinomaChina