- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03228368
The Predicted Potential of Quantitative T Cell Repertoire(TCR) in Anti-PD-L1 Treatment in NSCLC Patients
July 21, 2017 updated by: First Affiliated Hospital of Zhejiang University
The Predicted Potential of Quantitative T Cell Repertoire(TCR) Analysis Using Next-generation Sequencing (NGS) in Anti-PD-L1 Treatment in Non Small Cell Lung(NSCLC) Cancer Patients
This study is designed to evaluate the predicted potential of quantitative T cell repertoire (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen.
Treatment may continue until disease progression or unacceptable toxicity.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
10
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: Director of Department of Thoracic Oncology
- Email: doczq.2008@163.com
Study Contact Backup
- Name: The First Affiliated Hospital of College of Medicine, Zhejiang
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital of College of Medicine, Zhejiang University
-
Contact:
- Wei Chen
- Email: cli6274@gmail.com
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed of locally advanced or metastatic non small cell lung cancer progressed during or following treatment with a prior platinum-containing regimen and subsequently recevied atezolizumab.
Description
Inclusion Criteria:
- Histologically documented, locally advanced or metastatic NSCLC
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
- Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, or disease recurrence within 6 months of treatment with a platinum-based adjuvant and/or neoadjuvant regimen or combined modality with curative intent
- Measurable disease per RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and end organ function
- Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
- Recovery from all acute toxicities from previous therapy
Exclusion Criteria:
- Active or untreated central nervous system (CNS) metastases
- Spinal cord compression not definitively treated or not clinically stable
- Leptomeningeal disease
- Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia
- Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
- Pregnant or lactating women
- Significant cardiovascular, pulmonary, or autoimmune disease
- Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
- Prior treatment with or hypersensitivity to study drug(s) or related compounds
- Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
- Prior allogeneic bone marrow or solid organ transplant
- Known PD-L1 expression status from other clinical studies
- Positive human immunodeficiency virus (HIV) or hepatitis B or C
- Receipt of a live attenuated vaccine within 4 weeks prior to randomization
- Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
- Treatment with systemic corticosteroids within 2 weeks prior to randomization
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Atezolizumab (MPDL3280)
Atezolizumab 1200 milligrams (mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.
|
anti-programmed death-ligand 1 (PD-L1) antibody
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T cell repertoire
Time Frame: From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)
|
Change of T cell receptor repertoire during Anti-PL-L1 treatment.
|
From Screening until disease progression, death, or loss to follow-up (up to approximately 3 years overall)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 1, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
June 28, 2017
First Submitted That Met QC Criteria
July 21, 2017
First Posted (Actual)
July 24, 2017
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
July 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCR-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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 Non-Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Atezolizumab (MPDL3280A)
-
Incyte CorporationHoffmann-La Roche; Genentech, Inc.TerminatedUC (Urothelial Cancer) | NSCLC (Non-small Cell Lung Carcinoma)United States
-
Queen Mary University of LondonHoffmann-La RocheRecruitingUrogenital CancerUnited Kingdom
-
Genentech, Inc.CompletedHematologic Malignancies | TumorsSpain, France, United States, United Kingdom
-
Clovis Oncology, Inc.Genentech, Inc.TerminatedNon-small Cell Lung CancerUnited States
-
Health Pharma Professional ResearchWithdrawnMalignant Pleural Mesothelioma, Advanced | Malignant Pleural Mesothelioma, UnresectableMexico
-
Hoffmann-La RocheTerminatedSolid TumorUnited States, Spain, Canada, United Kingdom, Denmark, France, Germany, Israel, Italy, Netherlands, Switzerland
-
Hoffmann-La RocheCompletedSolid TumorsUnited States, Netherlands, Denmark, Spain, Canada, France
-
Hoffmann-La RocheCompletedUrinary Tract CancerHungary, Italy, Australia, Czechia, United Kingdom, Austria, Belgium, Brazil, Bulgaria, Croatia, Denmark, Estonia, Greece, Portugal, Spain, Canada, India, Romania, Swaziland, Switzerland, Poland, Ireland, Colombia, Germany, Argentina, China, Leban... and more
-
Queen Mary University of LondonHoffmann-La RocheUnknownBladder CancerUnited Kingdom, France, Spain, Netherlands
-
Hoffmann-La RocheCompletedSolid CancersUnited States, Belgium, France, Spain