Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

Not yet recruiting

• Conditions: NSCLC, Recurrent; NSCLC Stage IV

• Registration Number: NCT04492969
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-29
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-31
• Study Start: 2020-09-01
• Primary Completion: 2023-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oligo-progression disease rate in NSCLC patients developing acquired resistance to ICI treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Overall objective response rate to radiotherapy.	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.
Percentage of Participants With Adverse Events	Two years	Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.
Objective response rate in non-irradiated lesion	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.
Overall Survival since AR development.	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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China