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 4,000+ scientific posters on ePosters
  • More than 5,300+ 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

Exploring the Genome of the River Blindness Parasite
Researchers have decoded the genome of the parasite that causes the skin and eye infection known as river blindness.
Wednesday, December 07, 2016
Gene-Editing Improves Vision in Blind Rats
Scientists developed a targeted gene-replacement technique that can modify genes in both dividing and non-dividing cells in living animals.
Wednesday, December 07, 2016
Protein-Folding Gene Helps Heal Wounds
Researchers identified a protein that dramatically accelerates wound healing in animal models.
Wednesday, November 23, 2016
NIH Researchers Unveil New Wound-Healing Role for Protein-Folding Gene in Mice
The study found that topical treatment of an Hsp60-containing gel dramatically accelerates wound closure in a diabetic mouse model.
Friday, October 28, 2016
Gene Editing Corrects Sickle Cell Mutation
Researchers demonstrate a potential pathway to developing gene-editing treatments for sickle cell disease.
Wednesday, October 26, 2016
NIH Scientists Uncover Genetic Explanation for Frustrating Syndrome
Researchers at NIH have suggested that the multiple alpha tryptase gene copies might underlie health issues that affect a substantial number of people.
Tuesday, October 18, 2016
NIH Commits $6.7 M to Advance DNA, RNA Sequencing Technology
"Can you believe they make DNA sequencers the size of staplers?" asked Meni Wanunu, Ph.D. "Ideas that were crazy twenty years ago are now happening!"
Friday, October 07, 2016
“Sixth Sense” More Than a Feeling
NIH study of rare genetic disorder reveals importance of touch and body awareness.
Monday, September 26, 2016
The Genetics of Blood Pressure
Researchers have identifed areas of the genome associated with blood-pressure including 17 previously unknown loci.
Wednesday, September 21, 2016
Catalogue of Human Genetic Diversity Expands
The largest data set of human exomes to date has been assembled to better study seqence variants and their consequences.
Wednesday, September 07, 2016
$12.4M Awarded to Neural Regeneration Projects
The National Institutes of Health will fund six projects to identify biological factors that influence neural regeneration.
Friday, September 02, 2016
New Inflammatory Disease Discovered
NIH researchers have discovered a rare and potentially deadly disease - otulipenia - the mostly affects children.
Tuesday, August 23, 2016
Public Support for National Study
Survey shows the majority of respondents support or show willingness for national precision medicine study.
Thursday, August 18, 2016
Schizophrenia, Autism Share Genetic Causes
Monkey brain developmental atlas pinpoints when, where genes activate.
Tuesday, August 16, 2016
How Breast Cancers Resist Chemotherapy
Researchers discovered an unexpected way that breast cancers cells with mutant BRCA1 or BRCA2 genes acquire drug resistance and evade chemotherapies.
Wednesday, August 10, 2016
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Personality Traits, Psychiatric Disorders Linked to Specific Genomic Locations
Researchers have unearthed genetic correlations between personality traits and psychiatric disorders.
Genetics Control Regenerative Properties Of Stem Cells
Researchers define how genetic factors control regenerative properties of blood-forming stem cells.
Diabetes Missing Link Discovered
Researchers from the University of Auckland have shown that beta catenin plays a vital role in the control of insulin release from the pancreas.
Study Reveals New Role for Hippo Pathway in Suppressing Cancer Immunity
Hippo pathway signaling regulates organ size by moderating cell growth, apoptosis and stem cell renewal, but dysregulation contributes to cancer development.
Gene-Editing Improves Vision in Blind Rats
Scientists developed a targeted gene-replacement technique that can modify genes in both dividing and non-dividing cells in living animals.
Gene Editing Yields Tomatoes That Ripen Weeks Earlier
Research team develop method to make tomato plants flower and ripen fruit two weeks faster than current growth rates.
Exploring the Genome of the River Blindness Parasite
Researchers have decoded the genome of the parasite that causes the skin and eye infection known as river blindness.
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
Unexpected Role for Epigenetic Enzymes in Cancer
Researchers use epigenetics to identify the role of an enzyme family as regulators of genetic message interpretation in yeast.
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
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!