Skip to main content
An official website of the United States government

The ALCHEMIST Lung Cancer Trials

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, is a group of randomized clinical trials for patients with early-stage non-small cell lung cancer (NSCLC) whose tumors have been completely removed by surgery. 

Even with surgery and standard adjuvant (post-surgical) treatment, cancer will come back in about half of people with early-stage NSCLC. The ALCHEMIST trials were launched to test whether adding targeted therapy based on the genetics of a person’s tumor will help prevent the cancer from returning. 

ALCHEMIST includes a screening trial to identify potential participants who have changes in either of two genes, EGFR and ALK, that frequently drive cancer growth in people with NSCLC. Mutations in the EGFR gene are found in about 10% to 15% of non-Asian NSCLC patients and up to 50% of Asian patients. A rearrangement of the ALK gene affects another 5% to 6% of NSCLC patients.

Potential participants found to have EGFR alterations or the ALK rearrangement in their tumors could be assigned to trials to test drugs targeting these changes. The drugs being tested, erlotinib (Tarceva) for patients with EGFR mutations and crizotinib (Xalkori) for those with the ALK rearrangement, have already been approved for patients with advanced lung cancer that has these genetic changes.

Potential participants without EGFR or ALK changes in their tumors could be assigned to trials to test immunotherapy drugs. The drugs being tested, nivolumab (Opdivo) and pembrolizumab (Keytruda), are both a type of immunotherapy called immune checkpoint inhibitors.

Two ALCHEMIST trials, one testing erlotinib in people with EGFR mutations and the other testing nivolumab immunotherapy in those without EGFR or ALK changes, are closed to enrollment and awaiting results. The trials of crizotinib for patients with ALK-rearranged tumors and pembrolizumab immunotherapy are still open to new patients.

ALCHEMIST - Screening Trial [A151216]:

Patients who participate in the ALCHEMIST Screening Trial have their tumors tested to see if they have EGFR gene mutations or the ALK gene rearrangement. Approximately 8,000 patients will have their tumor tissue tested in the ALCHEMIST screening trial. All patients screened for ALCHEMIST will be monitored for 5 years. See the ALCHEMIST screening trial patient handout for more information.

ALCHEMIST - ALK Treatment Trial [E4512]:

People whose tumors are found to have the ALK rearrangement, known as an ALK-EML4 fusion, are eligible to join the ALCHEMIST ALK treatment trial. Participants in this trial are randomly assigned to receive crizotinib until they experience unacceptable toxicity or disease recurrence or to be observed and followed by their doctor at check-ups every 6 months. Participants’ health will be monitored for up to 10 years. See the ALCHEMIST ALK trial patient handout for more information.

ALCHEMIST – Pembrolizumab Immunotherapy Trial [A081801]:

Because earlier studies had found that the combination of chemotherapy and immunotherapy improves survival in people with advanced NSCLC without alterations in EGFR or ALK, ALCHEMIST researchers wanted to test immunotherapy for patients receiving adjuvant chemotherapy after surgery for early-stage NSCLC. So a second ALCHEMIST immunotherapy trial is comparing pembrolizumab, given either during or after chemotherapy, with chemotherapy alone for people whose early-stage NSCLC lacks EGFR mutations or the ALK rearrangement. People assigned to receive pembrolizumab and chemotherapy together will continue receiving pembrolizumab following completion of chemotherapy. After treatment, participants’ health will be monitored for up to 10 years. 

ALCHEMIST - EGFR Treatment Trial [A081105] (Closed):

People whose tumors had an EGFR mutation were referred to the ALCHEMIST EGFR treatment trial, to receive either erlotinib or a matching placebo pill for up to 2 years. This trial has completed enrollment.  

ALCHEMIST – Nivolumab Immunotherapy Trial [ANVIL; EA5142] (Closed):

The ALCHEMIST nivolumab immunotherapy trial was created for patients with early-stage NSCLC whose tumors do not contain the ALK or EGFR gene changes. Patients were randomly assigned to receive the drug nivolumab or be observed. After treatment, participants’ health is being monitored for up to 10 years. This trial has completed enrollment.

For More Information

The ALCHEMIST studies are being coordinated by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group, both members of the NCI-sponsored National Clinical Trials Network (NCTN).

For questions about this trial or about lung cancer, please call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).