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Prospective Observation of Failure Patterns in NSCLC Treated With ICIs | Clinical Trials | Clareo Health

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Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

Prospective Observational Study of Failure Patterns in Non-small Cell Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

NCT04492969•Fudan University

View on ClinicalTrials.gov

Summary

By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age between 18 and 75 years.
•ECOG PS 0-1.
•Pathologically confirmed stage IV NSCLC.
•Negative for driver genes including EGFR, ALK, and ROS-1.
•Patients achieved PR or CR after ICI treatment, as defined by RECIST 1.1.
•Patients with complete radiological information of baseline lesions.
•Life expectancy of more than 3 months.
•Ability to understand and willingness to provide the informed consent.
•Patients with oligo-progression disease (1-3 progression lesions in 1-2 organs) when developing acquired resistance to ICI.
•Radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. At least one of the irradiated lesion(s) should be evaluable according to RECIST 1.1.
+5 more criteria

Exclusion Criteria

•Severe autoimmune disease or other contradictions to ICI treatment.
•Mixed small cell with non-small cell lung cancer histology.
•Driver gene positive, including EGFR, ALK, and ROS-1.
•Pregnant or lactating women.
•History of any other malignancy.
•Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.
•Patients receiving immunosuppressive agents,or other investigational treatment. Long-term corticosteroid users are also excluded.
•Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
•Secondary malignancy.
•Histology transformation to non-NSCLC.
+6 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 1, 2020

Primary Completion Date

August 31, 2023

Completion Date

August 31, 2025

Last Updated

July 31, 2020

Enrollment

320

ESTIMATED participants

Conditions

NSCLC Stage IVNSCLC, Recurrent

Contacts

Zhengfei Zhu, MD

CONTACT

+86-18017312901 fuscczzf@163.com

Xiao Chu, PhD

CONTACT

+86-15821383376 crazychu0044@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 31, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

Inclusion Criteria

Exclusion Criteria

Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

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