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Protocol No. A151216
Principal Investigator Leal, Ticiana
Age Group Adult
Sponsor Type National
Title Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Objective The purpose of this research study is to examine lung cancer patients' surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.
Treatment Genetic testing will be done to learn if your tumor has any of these genetic changes. These tests will look at the genetic material of the tumor cells. All tissues in the body are made up of cells. Those cells contain DNA, which is your unique genetic material that carries the instructions for your body's development and function. Cancer can develop when changes in certain genes cause those cells to divide in an uncontrolled way and, sometimes, to travel to other organs.
Description For patients with non-squamous cell lung cancer, your tumor will be screened for genetic changes. Only about 1 in 10 patients will have the genetic changes required to be offered the EGFR or ALK treatment study. There are 2 different studies with 2 different drugs targeting tumors with certain genetic changes that you will be referred based on your genetic testing results. If your tumor has a genetic change in ALK, you may be offered the opportunity to participate in a clinical trial that will randomize you to receive either standard treatment plus crizotinib or standard treatment plus placebo, but not both. A placebo is a pill that looks like the study drug, but is inactive and does not contain the study drug. This is the ALCHEMIST-ALK study (E4512). If your tumor has a genetic change in EGFR, you may be offered the opportunity to participate in a clinical trial that will randomize you to receive standard treatment plus erlotinib or standard treatment plus placebo, but not both. This is the ALCHEMIST-EGFR study (A081105). For patients with non-squamous cell lung cancer with no genetic change in EGFR and ALK and your tumor will then be tested for genetic changes PD-L1. For patients with squamous cell lung cancer, your tumor will be tested for genetic changes in PD-L1 only. Your doctor will then evaluate you to see if you could be treated on a trial which will randomize you to receive either nivolumab or not have any treatment (EA5142). Click here for more info
- For pre-surgical patients: must have a suspected diagnosis of resectable non-small cell lung cancer and suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size ≥ 4cm).
- For post-surgical patients: must have completely resected non-small cell lung cancer with negative margins and have pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥ 4cm)
- Patients must not have received neoadjuvant therapy for lung cancer.
Applicable Disease Sites Lung
Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park; VA Hospital, Madison, WI