Tokyo, April 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061339) titled 'Pathological complete response and major pathological response as surrogate endpoints in RCTs of neoadjuvant systemic therapies for NSCLC' on April 25.

Study Type: Others,meta-analysis etc

Primary Sponsor: Institute - Yokohama City University Hospital

Condition: Condition - NSCLC Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - In 2024, Hines et al. reported that lack of correlation between pathological response and OS. Nonetheless, this null finding may be attributable to a statistical phenomenon known as the correlation of restricted range caused by label assignment. Because ICIs have shown substantial efficacy in nearly all RCTs, improving both pathological response and survival simultaneously, the data points tend to cluster within a narrow range, thereby underestimating the true surrogacy. We should not assess surrogacy directly from the raw data whose labels were assigned based on medical custom. In this systematic review, we evaluated study-level correlation coefficient and surrogate threshold effect (STE) for NSCLC neoadjuvant systemic therapies between pathological response and survival, using exhaustive label assignment method. 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 neoadjuvant systemic therapy for NSCLC are eligible for inclusion. Conference abstracts are accepted.

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

Treatment This study focuses on neoadjuvant systemic therapy, including chemotherapy, molecular targeted therapy, immune checkpoint inhibitors (ICI), and chemoimmunotherapy. 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. Key exclusion criteria - Non English articles.

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070186

Disclaimer: Curated by HT Syndication.