LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers
Description
Brief Summary
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 10 oncogenic drivers
(mutations in EGFR, BRAFV600E , MET exon 14, and HER2, rearrangements in ALK, RET, NTRK, 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.
Phase
N/AInclusion and Exclusion Criteria
- Clinical stage IA2-III lung cancers
- Potentially resectable if lung cancer suspicion confirmed pathologically
- Operable
- No concurrent malignancy
- No prior lung cancer within last 2 years
- Purely ground glass pulmonary opacity
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI