The ALCHEMIST Lung Cancer Trial
The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, is a group of clinical trials for patients with early-stage non-small cell lung cancer (NSCLC) that has been removed surgically. The ALCHEMIST trials involve genetic screening of tumor specimens removed during surgery for specific gene mutations and testing of adjuvant (post-operative) treatment with drugs that target those mutations. These therapies have been approved by the FDA for use in advanced lung cancer. Patients will have already had surgery to completely remove their tumors and should have finished other standard post-surgical chemotherapy with or without radiation therapy prescribed by their doctors before entering the treatment studies.
The ALCHEMIST-Screening study will examine tumor specimens from people who have non-small cell lung adenocarcinoma or other related types of lung cancer that have been surgically removed. Researchers will look for specific alterations in two genes, ALK and EGFR, that are thought to drive cancer growth and for which targeted therapies have been developed. Patients who have one of these alterations will then be referred to either of two treatment arms that are testing whether adjuvant treatment with the drugs crizotinib (Xalkori) or erlotinib (Tarceva) will prevent recurrence and improve survival. In the near future, a new immunotherapy arm will open as a part of ALCHEMIST for some of those patients whose tumor does not match the genetic changes being targeted in ALCHEMIST.
Patients whose tumors test positive for a rearrangement of the ALK gene known as an ALK-EML4 fusion will be referred to the ALCHEMIST-ALK arm. Approximately 5 percent of people with adenocarcinoma or other related types of NSCLC have this genetic mutation. Patients in this phase III treatment arm will be randomly assigned to receive the drug crizotinib or a matching placebo pill for 2 years, or until they experience unacceptable toxicity or disease recurrence. They will then be monitored for recurrence and survival.
Patients whose tumors harbor an activating mutation in the EGFR gene will be referred to the ALCHEMIST-EGFR arm. Mutations in EGFR are found in about 10 percent of non-small cell lung cancer cases in non-Asian people and up to 50 percent of cases in Asian patients. In this arm, patients will be randomly assigned to take the drug erlotinib or a matching placebo pill for up to 2 years, or until they experience unacceptable toxicity or a recurrence of their cancer. After treatment, participants will be monitored for recurrence and survival.
Some patients whose tumor does not match any of these genetic changes may be able to join an immunotherapy trial arm that is being planned. In this arm, patients will be randomly assigned to immunotherapy with nivolumab or to observation alone.
All patients screened for ALCHEMIST who are not eligible for any of the treatment arms will be monitored every 6 months for 5 years. Their monitoring data will be collected for an understanding of the natural history of these patients.
Researchers hope that identifying patients with early-stage lung cancer with known genetic abnormalities and treating them with drugs that target those abnormalities will help increase the number of people who can have better survival.
The ALCHEMIST studies are being coordinated by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group, members of the NCI-sponsored National Clinical Trials Network (NCTN), as part of the institute’s national strategy for precision medicine.
About the ALCHEMIST Trials
- NIH announces the launch of 3 integrated precision medicine trials; ALCHEMIST is for patients with certain types of early-stage lung cancer
(Posted: August 18, 2014) - The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, will identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival.
- ALCHEMIST (The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials): Questions and Answers
(Posted: August 18, 2014) - ALCHEMIST represents three integrated, precision medicine trials that are designed to identify people with early-stage lung cancer who have tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those molecular changes can lead to improved survival
- Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (ALCHEMIST)
(NCT02194738) - Protocol summary for the ALCHEMIST-Screening trial
- Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
(NCT02201992) - Protocol summary for the ALCHEMIST-ALK phase III clinical trial
- Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
(NCT02193282) - Protocol summary for the ALCHEMIST-EGFR phase III clinical trial