- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492969
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
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xiao Chu, PhD
- Phone Number: +86-15821383376
- Email: crazychu0044@163.com
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200031
- Fudan University Shanghai Cancer Center
-
Contact:
- Xiao Chu
- Phone Number: 15821383376
- Email: crazychu0044@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria (Part I):
- 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.
Exclusion Criteria (Part I):
- 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.
Inclusion Criteria (Part II, patients with OPD):
- 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 (Part II):
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.
Time Frame: at least 2 months after ICI treatment.
|
Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1) When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded. Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated. |
at least 2 months after ICI treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Adverse Events
Time Frame: Two years
|
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
|
Two years
|
Overall objective response rate to radiotherapy.
Time Frame: at least 4 weeks after radiotherapy.
|
When radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator.
Overall objective response rate (ORR) to radiotherapy will be recorded.
ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
|
at least 4 weeks after radiotherapy.
|
Objective response rate in non-irradiated lesion
Time Frame: at least 4 weeks after radiotherapy.
|
Objective response rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.
|
at least 4 weeks after radiotherapy.
|
Overall Survival since AR development.
Time Frame: Two years
|
OS was defined as the time from the date of enrollment until death by any cause.
Participants still alive at the time of data analysis were censored at the date of last follow-up.
|
Two years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-CSCOBMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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