Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Clinical stage IA2-III lung cancers
Potentially resectable if lung cancer suspicion confirmed pathologically
Operable

Exclusion Criteria:

No concurrent malignancy
No prior lung cancer within last 2 years
Purely ground glass pulmonary opacity

Study is for people with:

Lung Cancer

Estimated Enrollment:

1000

Study ID:

NCT04712877

Recruitment Status:

Recruiting

Sponsor:

Lung Cancer Mutation Consortium

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There are 5 Locations for this study

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University of California, Davis
Davis California, 95616, United States More Info
Ashley Dang-Chu
Contact
[email protected]
Tianhong Li, MD, PhD
Principal Investigator
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Peggy Romano
Contact
[email protected]
Sean Wightman, MD
Principal Investigator
St. Joseph's Hospital Orange
Orange California, 92868, United States More Info
Ron Bati
Contact
[email protected]
John Maurice, MD
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Shari Barnett
Contact
[email protected]
Jules Lin, MD
Principal Investigator
University of Washington
Seattle Washington, 98019, United States More Info
Lara Schiff
Contact
[email protected]
Christina Baik, MD, MPH
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

1000

Study ID:

NCT04712877

Recruitment Status:

Recruiting

Sponsor:


Lung Cancer Mutation Consortium

How clear is this clinincal trial information?

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