- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167657
SinTilimab After Radiation (STAR Study) (STAR)
November 15, 2019 updated by: Wang mengzhao, Peking Union Medical College Hospital
A Phase II Single-arm Study of Sintilimab After Thoracic Radiation in Previously Treated Advanced NSCLC
This is a single-arm phase II study, to investigator the efficacy and safety of sintilimab after radiation in advanced NSCLC, who had failed first line systemic therapy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
37
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Xu, M.D.
- Phone Number: 861069155154
- Email: maraxu@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Department of Respiratory Medicine, Peking Union Medical College Hospita
-
Contact:
- Mengzhao Wang, MD
- Phone Number: +86 010-69155039
- Email: mengzhaowang@sina.com
-
Sub-Investigator:
- Wei Zhong, MD
-
Contact:
- Yan Xu, MD
- Phone Number: +86 18500296828
- Email: maraxu@163.com
-
Sub-Investigator:
- Yan Xu, MD
-
Sub-Investigator:
- Minjiang Chen, MD
-
Sub-Investigator:
- Jing Zhao, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent;
- Age ≥ 18 years ;
- Histologically or cytologically confirmed NSCLC, without EGFR sensitive mutation (must) or no known ALK/ROS1 positive;
- Stage IIIB-IV (AJCC 8th edition) or recurrent/progressive disease after multidisciplinary treatment for local advanced disease;
- Patients must have disease progression or recurrence after receiving first line systemic therapy for advanced or metastasis disease: 1) Maintenance therapy after platinum based chemo-doublet shall not be considered as a separated treatment regimen, 2)Patients who had received neo-adjuvant/adjuvant therapy or radical chemo- radiotherapy for local advanced disease and relapsed after 6 month or later, must have failed first line treatment for recurrent disease before enrollment;
- ECOG PS 0-1, with expected survival over 3 months;
- Patients shall have at least one leision eligible for radiation, e.g. bone metastasis, intrapulmonary node, adrenal disease, etc. Patient must have at least one disease (other than radiation target) according to RECIST 1.1: 1) Patient must have received radiation for 1 location after disease progression or recurrence after first line treatment for advanced or metastasis disease, 2) Time between first dose of sintilimab and last radiation shall be no longer than 3 weeks
- Adequate marrow and organ function as per baseline CBC/CMP/Urine test;
- Prior anti-tumor therapy should be completed at least 4 weeks before enrollment, and adverse events of prior treatment shall be return to ≤G1 per CTCAE (except for alopecic or any non-clinical significant laboratory abnormalities) ;
- Women with childbearing potential or men whose female partners are with childbearing potential must agree to use efficient contraceptive methods during the study treatment period until 90 days after last dose of study treatment.
Exclusion Criteria:
- Previously treated by any immune therapy;
- Active infection including HBV, HCV, and HIV;
- Serious marrow or organ malfunction, e.g. hepatic or renal dysfunction;
- Patients with unstable CNS metastasis or require corticosteroids to control CNS symptoms. Patients with stable brain metastasis after radiation (3 weeks) will be eligible;
- Active or autoimmune disease;
- ILD, including drug-induced ILD, radiation pneumonia that required corticosteroids, or any clinical implication for active ILD;
- Any course that lead to treatment with continuous systemic corticosteroids >10 mg/day prednisone or equivalent dose of other steroids;
- Pregnant or lactating women.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm1
Sintilimab monotherapy every 3 weeks, after a radiation targeting a single location no less than dose 30Gy/5f.
|
Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months. Before enrollment, patient should undergo radiation no less than dose 30Gy/5f. Sintilimab shall be started no later than 3 weeks after radiation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: Time Frame: up to 12 months after enrollment or study close
|
ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons ORR (per RECIST 1.1 as assessed by the investigator) is defined as the proportion of patients with a complete response (CR) or partial response (PR) as their best respons
|
Time Frame: up to 12 months after enrollment or study close
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mengzhao Wang, M.D., Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2019
Primary Completion (Anticipated)
April 15, 2022
Study Completion (Anticipated)
April 15, 2023
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-1856
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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