Prospective Observation of Failure Patterns in NSCLC Treated With ICIs
NCT ID: NCT04492969
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
320 participants
OBSERVATIONAL
2020-09-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
* ECOG PS 0-2.
* Life expectancy of more than 3 months.
* Complete radiological information of all lesions during the follow-up.
* Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.
* Adequate bone marrow function within 1 week prior to the enrollment: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
* Ability to understand and willingness to provide the informed consent.
Exclusion Criteria
* 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.
* Ineligible for radiotherapy in the opinion of the investigator. Or none of the OPD are evaluable by RECIST 1.1.
* ECOG PS 3 or worse.
* Short life expectancy (less than 3 months).
* Unable to provide complete radiological information of lesions.
* Inadequate bone marrow function.
* Cannot understand or unwilling to provide the informed consent.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhengfei Zhu
Professor
Principal Investigators
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Zhengfei Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhengfei Zhu, MD
Role: primary
Xiao Chu
Role: backup
Other Identifiers
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2019-CSCOBMS
Identifier Type: -
Identifier Source: org_study_id