Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in NSCLC
Establishment of a Comprehensive Evaluation System for the Efficacy of Immunologic Checkpoint Inhibitors in the Treatment of Advanced Non-small Cell Lung Cancer
1 other identifier
observational
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2023
CompletedFebruary 24, 2021
February 1, 2021
2.2 years
November 6, 2020
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
circulating tumor cell
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
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
Interventions
the patients receive necessary treatment without special intervention
Eligibility Criteria
The patients can accepted immune checkpoint inhibitors.
You may qualify if:
- Ages ≥18 years of age. Histologically confirmed stage IIIB-IV non-squamous non-small cell lung cancer. Life expectancy of at least 3 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Fang
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 16, 2020
Study Start
March 3, 2021
Primary Completion
May 30, 2023
Study Completion
May 30, 2023
Last Updated
February 24, 2021
Record last verified: 2021-02