- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04629027
Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC
February 23, 2021 updated by: Jian Fang, Peking University Cancer Hospital & Institute
Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer
Inhibitors of programmed cell death protein 1 (PD-1) and programmed cell death ligand 1 (PD-L1) are effective therapies for metastatic NSCLC lacking sensitizing EGFR or ALK mutations.
First-line combination regimens that include a PD-1 or PD-L1 inhibitor may maximize the chance of response and lead to prolonged survival.
PD-L1 expression is the only validated predictive biomarker for selecting pembrolizumab treatment.
However, it is far from being the ideal biomarker and its role in predicting efficacy from ICPIs remains undefined due to conflicting results from randomized clinical trials.
The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs as well as to prevent inappropriate allocation of health resources.
Further studies are clearly needed to better understand the mechanism of action of immunotherapy in vivo thus allowing the identification of other predictive biomarkers.
Therefore, our research team intends to explore advanced non-small cell lung cancer treated with immune checkpoint inhibitors, by combining the evaluation criteria of solid tumor efficacy evaluation criteria (RECIST1.1),
clinical pathological characteristics of patients, and dynamic monitoring of peripheral blood molecular biological markers, finding the correlation with the efficacy of immunotherapy, establish a detection mode for selecting patients with clinical benefits.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
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: Jian Fang
- Phone Number: +861088196478
- Email: fangjian5555@163.com
Study Contact Backup
- Name: Jie Zhang
- Phone Number: +861088196478
- Email: zhangjie@bjmu.edu.cn
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Beijing Cancer Hospital
-
Contact:
- Jian Fang
- Phone Number: +86-010-88196478
- Email: bcht2_mj@163.com
-
Contact:
- Jie Zhang
- Phone Number: +86-010-88196478
-
-
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
The patients can accepted immune checkpoint inhibitors.
Description
Inclusion Criteria:
Ages ≥18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer. Life expectancy of at least 3 months.
Exclusion Criteria:
- Previous treatment . Untreated CNS metastases. Active autoimmune disease. Surgery or significant traumatic injury. Active infection. History of allergy or hypersensitivity to immunotherapy components. Women are breastfeeding or pregnant. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
circulating tumor cell
Time Frame: 3 year
|
The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.
|
3 year
|
T cell marker
Time Frame: 3 year
|
The selection of patients most likely to benefit from immunotherapy is crucial in order to avoid exposure to potentially toxic and ineffective drugs.
|
3 year
|
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 (Anticipated)
March 3, 2021
Primary Completion (Anticipated)
May 30, 2023
Study Completion (Anticipated)
May 30, 2023
Study Registration Dates
First Submitted
November 6, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 16, 2020
Study Record Updates
Last Update Posted (Actual)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immune Checkpoint Inhibitors
Other Study ID Numbers
- 2020-2-2153
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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