Corporate Banner
Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

NIH Announces the Launch of 3 Integrated Precision Medicine Trials

Published: Tuesday, August 26, 2014
Last Updated: Tuesday, August 26, 2014
Bookmark and Share
ALCHEMIST is for patients with certain types of early-stage lung cancer.

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

ALCHEMIST is supported by the NCI, part of the National Institutes of Health, with coordination of the component trials by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group. All of the NCI-supported National Clinical Trials Network (NCTN) groups collaborated in the development of ALCHEMIST and are participating in the component trials.

People enrolled in ALCHEMIST will need to undergo surgical removal of their tumors; have been diagnosed with lung adenocarcinoma or similar types of lung cancer as identified by examining the tissue; and will need to complete standard therapy after surgery, consisting of chemotherapy with or without radiation therapy as prescribed by their physician.

In the ALCHEMIST screening trial, the surgically removed tissue will be tested in a central laboratory for certain genetic changes in two genes, ALK and EGFR. Participants with tumors found to harbor EGFR mutations or rearrangement of the ALK gene will then be referred to one of two randomized, placebo-controlled ALCHEMIST treatment trials. These studies will evaluate the value of adding therapy with specific agents targeted against two genetic alterations, erlotinib (EGFR) and crizotinib (ALK), in the post-operative setting. The U.S. Food and Drug Administration has approved these drugs for the treatment of patients with advanced forms of lung cancer whose tumors harbor the targeted genetic alterations. However, it is not known if these agents will be beneficial when administered to patients who are clinically free of disease. The goal of the trials is to determine whether erlotinib or crizotinib will prevent lung cancer recurrence, as well as prolong life, when used against tumors that carry specific mutations.

The three component trials of ALCHEMIST are:

• ALCHEMIST - Screening component (A151216)– Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigators: Pasi A. Janne, M.D., Ph.D., and Geoffrey Oxnard, M.D., Dana-Farber Cancer Institute, Boston.
http://www.cancer.gov/clinicaltrials/NCT02194738
• ALCHEMIST - EGFR Treatment component (A081105) - Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigator: Ramaswamy Govindan, M.D., Washington University, St. Louis.
http://www.cancer.gov/clinicaltrials/NCT02193282
• ALCHEMIST - ALK Treatment component (E4512)- Coordinated by ECOG-ACRIN; Principal Investigator: David E. Gerber, M.D., University of Texas Southwestern Medical Center at Dallas.
http://www.cancer.gov/clinicaltrials/NCT02201992

Alterations in EGFR and ALK genes are not common. In the United States, about 10 percent of patients with lung adenocarcinoma and similar types of lung cancer will have tumors with alterations in the EGFR gene, and 5 percent will have alterations of the ALK gene. ALCHEMIST will screen about 6,000 to 8,000 potential participants at hundreds of sites across the United States over five to six years to identify those with EGFR and ALK alterations who would be eligible for the two ALCHEMIST treatment trials. The researchers expect a total enrollment of about 800 patients in those treatment trials. All screened participants, irrespective of the marker status of their tumors, will be followed for five years in the screening trial.

All participants in ALCHEMIST will continue to receive the best care possible for their lung cancer. At the conclusion of the treatment trials, statisticians will analyze the survival of patients who received an additional genetically-targeted drug therapy versus patients who received standard therapy alone.

ALCHEMIST involves substantial collaborations with biotechnology and pharmaceutical partners. For the ALCHEMIST screening component, central laboratory testing for EGFR gene mutations and for the ALK gene rearrangement will be performed by Response Genetics, Inc., Los Angeles. For the ALCHEMIST treatment trials, Pfizer, New York City, will provide crizotinib under a clinical trials agreement with the ECOG-ACRIN Cancer Research Group. Astellas Pharma US, Inc., Northbrook, Illinois, will provide erlotinib under a cooperative research and development agreement with NCI for the clinical development of erlotinib.

“This approach highlights the ability of NCTN to efficiently screen large numbers of patients in order to identify those with early-stage EGFR mutant or ALK rearranged lung cancer," said Monica Bertagnolli, M.D., Dana-Farber Cancer Institute, head of the lead network (Alliance) for ALCHEMIST. "Without this capability, it would be impossible to identify a sufficient number of patients needed to perform clinical trials to determine whether EGFR or ALK inhibitors prolong survival in early-stage lung cancer.”

ALCHEMIST incorporates a number of other aspects of evolving clinical research and medical practice, including DNA sequencing and genomic analysis of tumor tissue, and possible additional genomic analysis at the time of lung cancer recurrence. Moreover, every participant enrolled in ALCHEMIST will also be studied for cancer risk characteristics, and their tumor tissue will be analyzed with advanced sequencing technologies in a research genomics initiative conducted by the NCI Center for Cancer Genomics (CCG). This research will capitalize on the foundation of CCG’s earlier effort, The Cancer Genome Atlas, which is a collaboration with the National Human Genome Research Institute, another component of NIH.

Results from ALCHEMIST may also benefit future lung cancer patients by helping scientists to:

• Screen for molecular features that may predict response to a drug with a given mechanism of action
• Analyze tumor specimens at relapse to define mechanisms of resistance
• Develop a public database that links clinical outcomes with molecular tumor characteristics.

ALCHEMIST is the second precision medicine clinical trial to launch as part of the new NCTN. The first, Lung-MAP, for patients with advanced squamous cell lung cancer, launched in June 2014.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Drug Might Help Treat Sepsis
A DNA enzyme called Top1 plays a key role in turning on genes that cause inflammation in mouse and human cells in response to pathogens. A drug blocking this enzyme rescued mice from lethal inflammatory responses, suggesting a potential treatment for sepsis.
Wednesday, May 18, 2016
NIH Funds New Studies on Ethical, Legal and Social Impact of Genomic Information
Four new grants from the National Institutes of Health will support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information.
Wednesday, May 18, 2016
Researchers Identify Genetic Links to Educational Attainment
Researchers at NIH have suggested that the large genetics analyses may be able to help discover biological pathways as well.
Thursday, May 12, 2016
Submissions Open for the Cancer Moonshot Program
NCI opens online platform to submit ideas about research for Cancer Moonshot.
Tuesday, April 19, 2016
NIH Sequences Genome of a Fungus
Researchers at the Institute have sequenced genome of human, mouse and rat Pneumocystis that cause life-threatening Pneumonia in immunosuppressed hosts.
Tuesday, April 12, 2016
Decoding Ties Between Vascular Disease, Alzheimer’s
NIH consortium uses big data, team science to uncover complex interplay of factors.
Tuesday, March 15, 2016
Researchers Find Link Between Death of Tumor-Support Cells and Cancer Metastasis
Researchers at NIH have found that the lifespan of supportive cells in a tumor may control the spread of cancer.
Tuesday, February 23, 2016
Tick Genome Reveals Secrets of a Successful Bloodsucker
NIH-funded study could lead to new tick control methods.
Tuesday, February 09, 2016
Genomic Signature Shared by Five Types of Cancer
National Institutes of Health researchers have identified a striking signature in tumor DNA that occurs in five different types of cancer.
Monday, February 08, 2016
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Thursday, February 04, 2016
Genome-Wide Study Yields Markers of Lithium Response
An international consortium of scientists has identified a stretch of chromosome that is associated with responsiveness to the mood-stabilizing medication lithium among patients with bipolar disorder.
Monday, February 01, 2016
Schizophrenia’s Strongest Known Genetic Risk Deconstructed
Suspect gene may trigger runaway synaptic pruning during adolescence – NIH-funded study.
Thursday, January 28, 2016
NIH Genome Sequencing Program Targets the Genomic Bases of Common, Rare Disease
The National Institutes of Health will fund a set of genome sequencing and analysis centers whose research will focus on understanding the genomic bases of common and rare human diseases.
Friday, January 15, 2016
Three Glaucoma-Related Genes Discovered
NIH-funded genetics analysis of glaucoma is largest to date.
Tuesday, January 12, 2016
International Study Reveals New Genetic Clues to AMD
NIH-funded research provides framework for future studies of AMD biology, therapy.
Tuesday, December 22, 2015
Scientific News
Scientists Find Evidence That Cancer Can Arise Changes
Researchers at Rockefeller University have found a mutation that affects the proteins that package DNA without changing the DNA itself can cause a rare form of cancer.
Modified Microalgae Converts Sunlight into Valuable Medicine
A special type of microalgae can soon produce valuable chemicals such as cancer treatment drugs and much more just by harnessing energy from the sun.
Breakthrough Approach to Breast Cancer Treatment
Scripps scientists have designed a drug candidate that decreases growth of breast cancer cells.
Loss Of Y Chromosome Increases Risk Of Alzheimer’s
Men with blood cells that do not carry the Y chromosome are at greater risk of being diagnosed with Alzheimer’s disease. This is in addition to an increased risk of death from other causes, including many cancers. These new findings by researchers at Uppsala University could lead to a simple test to identify those at risk of developing Alzheimer’s disease.
A Guide to CRISPR Gene Activation
A comparison of synthetic gene-activating Cas9 proteins can help guide research and development of therapeutic approaches.
Gene That Lowers Heart Attack Risk Identified
Individuals with a rare twelve-letter deletion from a gene on chromosome 17 have significantly reduced non-HDL cholesterol levels and a 35% lower than average risk of heart disease.
Testing Non-Breast/Ovarian Cancer Genes
Researchers have found that expanding gene panel beyond breast/ovarian cancer genes in these patients does not add any clinical benefit. Instead, testing has produced more questions than answers.
Myeloid-Derived Suppressor Cells Play Role in Tumor Growth
Researchers at Baylor College of Medicine have reported a new mechanism that helps cancer cells engage myeloid-derived suppressor cells.
Cancer Cells Coordinate to Form Roving Clusters
Rice University scientists identify ‘smoking gun’ in metastasis of hybrid cells.
Genes For Nose Shape Found
Genes that drive the shape of human noses have been identified by a UCL-led study.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!