NCT04712877

Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected Lung Cancers

StatusRecruiting

PhaseNot specified

SponsorLung Cancer Mutation Consortium

Primary completionDec 31, 2027 (estimated)

At risk: Primary completion moved at least 2 years 6 months later.

See at-risk trials from Lung Cancer Mutation Consortium

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 6, 2026 Primary and study completion dates pushed to Dec 31, 2027
- Eligibility criteria expanded, about 6 words
- Trial status changed: Unknown → Recruiting
- Trial sites expanded: 21 → 25 locations
Minor Changed Aug 2, 2026 Registry marked status Unknown; last known: Recruiting
Notable Jul 15, 2024 Primary completion date: Jun 15, 2024 to Jun 15, 2025
- Trial status: Recruiting to Unknown
- Study sites: 15 to 21
- Study completion date: Jun 15, 2025 to Jun 15, 2026
v5
Minor Sep 8, 2023 Study sites: 5 to 15v4
Notable Nov 8, 2022 Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
- Primary completion date: Jul 1, 2023 to Jun 15, 2024
- Start date changed from estimate of Apr 1, 2021 to Jun 15, 2022
- Study sites: 0 to 5
- Study completion date: Nov 1, 2023 to Jun 15, 2025
Notable Mar 2, 2021 Lead sponsor: Lung Cancer Research Foundation to Lung Cancer Mutation Consortium
- Start date: Feb 1, 2021 to Apr 1, 2021
- Collaborators expanded, about 4 words
v2
Jan 14, 2021 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Proportion of Patients who Possess Actionable Oncogenic Drivers

Timeframe: 8 weeks

Secondary (1)

Tumor Mutation Burden (TMB) Assessment

Arms and interventions

Diagnostic tests: ctDNA, tumor NGS

Sites

25 sites in 1 country

About this trial

This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers.

Trial details

Enrollment: 1,000 participants (estimated)
Started: Jun 15, 2022
Study completion: Dec 31, 2027 (estimated)
Eligibility: all ages, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: NSCLC
Collaborators: Lung Cancer Research Foundation
Official title: LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
First posted: Jan 15, 2021
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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