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Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer: individual-patient-data and study-level analyses

Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer: individual-patient-data and study-level analyses - Objective response, disease control rate, and progression-free survival, as surrogates of overall survival in trials evaluating immune checkpoint inhibitor regimens for advanced non-small cell lung cancer: individual-patient-data and study-level analyses

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000047001
Enrollment
Unknown
Registered
2022-02-25
Start date
2022-02-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

None listed

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Independent-patient-level analysis part] Patients should have advanced/locally-advanced/metastatic NSCLC including both squamous and non-squamous cell pathology. Specific inclusion nor exclusion criterion are not set for disease stage, PS, level of PD-L1 expression, status of EGFR mutation, ALK translocation, ROS, and RET. [Study-level analysis part] Study selection: We will include RCTs of any phase that medically treating the advanced/locally-advanced/metastatic NSCLC patients. Only articles written in English language will be included and conference abstracts will be excluded. Patient selection: Patients should have advanced/locally-advanced/metastatic NSCLC including both squamous and non-squamous cell pathology. Specific inclusion nor exclusion criterion are not set for disease stage, PS, level of PD-L1 expression, status of EGFR mutation, ALK translocation, ROS, RET

Exclusion criteria

Exclusion criteria: [Independent-patient-level analysis part] Not defined. [Study-level analysis part] Non-English article and conference abstract.

Design outcomes

Primary

MeasureTime frame
This study consist of two parts: independent-patient-data analysis and trial-level analysis parts. [Independent-patient-level analysis part] Patients will be classified based on RECIST evaluation, CR, PR, SD, and PD. Then, overall survivals will be compared between group using hazard ratio. Correlation between PFS and OS will be also assessed. [Study-level analysis part] The weighted Spearman's rank correlation coefficient (r) will be used as the indicator to assess the surrogacy. The correlation with HRos will be assessed for ORorr, ORdcr, and HRpfs.—

Countries

Japan

Contacts

Public ContactNobuyuki Horita

Yokohama City University Hospital Chemotherapy Center

horitano@yokohama-cu.ac.jp+810081457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026