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Lung Cancer Mutation Consortium Begins Study Screening Patients for Neoadjuvant Therapy Biomarkers

NEW YORK – The Lung Cancer Mutation Consortium said on Tuesday it has begun an umbrella trial, called LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancer, or LEADER, in which it will screen early-stage lung cancer patients for driver mutations that can be targeted with neoadjuvant therapy.

In the trial, the LCMC will enroll 1,000 lung cancer patients who are eligible for neoadjuvant treatment, screen them for 10 therapeutically targetable driver mutations, and match them to available drugs or industry-sponsored trials exploring the activity of targeted monotherapies or combination therapies. The researchers will prioritize enrollment of patients with resectable non-squamous non-small cell lung cancer, but patients with squamous cell cancer may also be enrolled.

LCMC is an association of more than 20 US cancer centers focused on improving understanding of lung cancers with genetic alterations and is using genetic testing to match patients to precision oncology therapies and clinical trials. The nonprofit Lung Cancer Research Foundation coordinates and supports the activities of the LCMC and is facilitating the LEADER trial. The organizations hope to collect data within the trial that will improve oncologists' ability to make treatment decisions for their early-stage lung cancer patients before undergoing surgery.

The trial will use two Foundation Medicine tests, FoundationOne CDx and FoundationOne Liquid, to screen patients for ALK rearrangements, BRAF V600E mutations, EGFR sensitizing mutations, HER2 mutation, HER2 amplification, MET amplification, MET exon 14 mutation, RET rearrangements, NTRK rearrangement, or ROS1 rearrangements. Researchers will use the results to identify an appropriate neoadjuvant therapy for patients, including enrolling them in an industry-sponsored trial of a drug being investigated in patients with the same tumor marker or finding other clinical trials for patients who lack targetable mutations. Patients' doctors can also decide to provide treatment outside of a clinical trial.

The association is expecting to detect an actionable oncogenic driver in 33 percent of tested patients, while two-thirds of patients may receive treatment deemed appropriate by their care teams, which may include checkpoint inhibitors and other drugs.

For patients who aren't enrolled in a clinical trial, researchers will continue to collect and screen ctDNA samples before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. LCMC has also partnered with the Thoracic Surgery Oncology Group to enroll patients for the study.