Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061746) titled 'HR of PFS as surrogate endpoints for HR of OS in RCTs of systemic immuno-therapies for advanced, locally advanced, and relapsed NSCLC' on May 30.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Yokohama City University Hospital

Condition: Condition - advanced, locally advanced, and relapsed NSCLC Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Although OS is universally recognized as the gold-standard endpoint in oncology clinical trials due to its direct clinical benefit to patients and objective, bias-free measurement, evaluating it has become ironically complex. Thanks to therapeutic breakthroughs by ICIs, the survival of patients with inoperable NSCLC spans several years. Consequently, executing randomized controlled trials (RCTs) with mature OS as the primary endpoint requires protracted follow-up periods, making them increasingly impractical. To overcome this logistical barrier, intermediate metrics such as progression-free survival (PFS) have gained widespread adoption as a primary endpoint. Most of published systematic review did not show very good relationship between HRs of PFS and OS, partially due to pseudo-progression. Another issue is underestimating the surrogacy due to statistical phenomenon, insufficient correlation by restricted range. Recent ICI trials showed highly favorable HRs of PFS and OS because of excellent therapeutic effect by ICI and because of medical tradition assigning standard treatment to the reference arm and novel treatment to the experiment arm. In this study, we conducted a trial-level systematic review to assess the formal validity of HR of PFS as a surrogate endpoint for HR of OS in RCTs with ICI for advanced, locally advanced, and relapsed NSCLC. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Study selection Articles written in English that present a randomised controlled trial (RCT) evaluating systemic immune-therapy for advanced, locally advanced, and relapsed NSCLC are eligible for inclusion. Conference abstracts are not accepted.

Patients Patients with operable NSCLC are evaluated, irrespective of pathological subtype or driver mutation, provided they are considered candidates for systemic immune-therapy by the original study authors.

Treatment This study focuses on ICI-based systemic immuno-therapy such as ICI monotherapy, dual ICI therapy, and chemoimmunotherapy. Absence or presence of previous systemic therapy is not considered. However, subgroup analysis focusing on first-line treatment and on second- or later-line treatment are expected. Key exclusion criteria - Conference abstracts are not accepted.

Systematic therapy without ICI is not allowed. Multimodal treatment combined with radiotherapy is excluded. Studies utilising regimens containing obsolete cytotoxic agents, such as mitomycin C and vindesine, are also excluded as they do not represent current standard-of-care.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 29 Day Anticipated trial start date - 2026 Year 05 Month 29 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070662

Disclaimer: Curated by HT Syndication.