NIH Announces the Launch of 3 Integrated Precision Medicine Trials; ALCHEMIST is for Patients with Certain Types of Early-Stage Lung Cancer

Editor’s note: Oncologists sometimes treat late-stage lung cancer patients based on the results of molecular tumor tests, which can reveal genetic mutations that cause tumor growth. This story is about a new study launched to find early stage lung cancer patients whose tumors have mutations in the EGFR or ALK genes. The study will explore whether drugs targeted against those genes will improve survival for the patients.

“The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, was launched today to 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.

“ ‘We believe that the findings from ALCHEMIST will not only help answer an important question about the addition of targeted therapies in earlier stage disease but will also help us in understanding the prevalence and natural history of these genomic changes in earlier stage lung cancer. We also hope to gain a better understanding as well regarding the genetic changes in the tumor at the time of recurrence,’ said Shakun Malik, M.D., head of Thoracic Cancer Therapeutics in the Clinical Investigations Branch of the National Cancer Institute (NCI). ‘The findings will help to define clinical, biologic and molecular behaviors of this type of lung cancer.’ “


Study Identifies Novel Genomic Changes in the Most Common Type of Lung Cancer; TCGA Finds Mutations in a Key Cancer-Causing Pathway, Expanding Targets for Existing Drugs

Editor’s note: Cancer is caused by genetic mutations that lead to excess cell growth and tumor formation. Scientists have identified many specific cancer-causing mutations, and drugs have been developed to target and treat tumors with some of these specific mutations. Researchers recently found mutations in lung adenocarcinoma tumors that they had not seen in that type of cancer before. The discovery could eventually lead to new treatment options for some patients who have these mutations.

“Researchers from The Cancer Genome Atlas (TCGA) Research Network have identified novel mutations in a well-known cancer-causing pathway in lung adenocarcinoma, the most common subtype of lung cancer. Knowledge of these genomic changes may expand the number of possible therapeutic targets for this disease and potentially identify a greater number of patients with treatable mutations because many potent cancer drugs that target these mutations already exist.

“TCGA is jointly funded and managed by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), both part of the National Institutes of Health. A TCGA analysis of another, less common, form of lung cancer, squamous cell carcinoma, was reported in 2012.

“In this new study, published online July 9, 2014, in the journal Nature, researchers examined the genomes, RNA, and some protein from 230 lung adenocarcinoma samples. In three-quarters of the samples, the scientists ultimately identified mutations that put a cell signaling pathway known as the RTK/RAS/RAF pathway into overdrive.”


Squamous Lung Cancer ‘Master Protocol’ Brings Cancer Research into the 21st Century


Clinical trials help determine whether new cancer treatments are safe and effective, and they provide access to cutting-edge drugs that patients wouldn’t otherwise be able to have. But the clinical trial system is notoriously inefficient, slow, expensive, and laborious. Now, a new and ambitious clinical trial design called the Lung Cancer Master Protocol seeks to overhaul the system, promising to benefit patients and drug companies alike. Continue reading…


Deaths from Lung Cancer Are Decreasing

Deaths from lung cancer have been decreasing across the U.S., contributing to an overall trend of falling cancer death rates, according to a report coauthored by several major medical and research institutions. Covering the period from 1975 to 2010, the report finds that the decrease in lung cancer deaths has accelerated in recent years. The rate of new lung cancer cases has also fallen, though to a lesser extent. Much of this trend is likely due to the significant reduction in tobacco smoking in past decades, which is producing a delayed effect. The report also showed that the presence of additional illnesses aside from cancer, which can greatly affect outcomes in some other cancer types, has less of an effect on prognosis in lung cancer.


Criteria for the Use of Omics-Based Predictors in Clinical Trials

“The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to ‘omics’-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.”


Criteria for the Use of Omics-Based Predictors in Clinical Trials

“The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to ‘omics’-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.”


Criteria for the Use of Omics-Based Predictors in Clinical Trials

“The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to ‘omics’-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.”


Criteria for the Use of Omics-Based Predictors in Clinical Trials

“The US National Cancer Institute (NCI), in collaboration with scientists representing multiple areas of expertise relevant to ‘omics’-based test development, has developed a checklist of criteria that can be used to determine the readiness of omics-based tests for guiding patient care in clinical trials. The checklist criteria cover issues relating to specimens, assays, mathematical modelling, clinical trial design, and ethical, legal and regulatory aspects. Funding bodies and journals are encouraged to consider the checklist, which they may find useful for assessing study quality and evidence strength. The checklist will be used to evaluate proposals for NCI-sponsored clinical trials in which omics tests will be used to guide therapy.”


National Cancer Institute's 'RAS Project' Takes Aim at Common Cancer-Driving Protein

The National Cancer Institute (NCI) is organizing a massive collaborative initiative between its laboratory and hundreds of outside researchers to discover cancer treatments targeting a class of genes called RAS genes and their products, RAS proteins. RAS genes, including their most common form, KRAS, are mutated in one-third of all cancers. Although the important role of RAS in cancer has been known for over 30 years, no treatments targeting RAS have been developed so far, because RAS proteins lack a ‘binding site’ where drugs could attack. However, recent research has uncovered potential weaknesses in RAS that future treatment might exploit. The NCI’s RAS Project aims to ‘crowdsource’ the expertise of many researchers to better understand and tackle RAS.