NCT01014286

Lung Cancer Mutation Consortium Protocol

Completed Last updated 13 January 2025

What this trial tests

trial in Adenocarcinoma of Lung, Stage IV in 1,100 participants. Completed in 12 January 2019.

Timeline

16 September 2009

Primary endpoint
1 September 2016

12 January 2019

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,100
Start date	16 September 2009
Primary completion	1 September 2016
Estimated completion	12 January 2019
Sites	1 location across United States

Conditions studied

• Adenocarcinoma of Lung, Stage IV — all drugs for Adenocarcinoma of Lung, Stage IV →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with Adenocarcinoma of Lung, Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs.
   Kris MG, Johnson BE, Berry LD, Kwiatkowski DJ, et al · · 2014 · cited 1333× · PMID 24846037 · DOI 10.1001/jama.2014.3741
2. Genotyping and genomic profiling of non-small-cell lung cancer: implications for current and future therapies.
   Li T, Kung HJ, Mack PC, Gandara DR. · · 2013 · cited 369× · PMID 23401433 · DOI 10.1200/jco.2012.45.3753
3. Implementing multiplexed genotyping of non-small-cell lung cancers into routine clinical practice.
   Sequist LV, Heist RS, Shaw AT, Fidias P, et al · · 2011 · cited 276× · PMID 22071650 · DOI 10.1093/annonc/mdr489
4. A platform for rapid detection of multiple oncogenic mutations with relevance to targeted therapy in non-small-cell lung cancer.
   Su Z, Dias-Santagata D, Duke M, Hutchinson K, et al · · 2011 · cited 146× · PMID 21227397 · DOI 10.1016/j.jmoldx.2010.11.010
5. Genotype-driven therapies for non-small cell lung cancer: focus on EGFR, KRAS and ALK gene abnormalities.
   Gaughan EM, Costa DB. · · 2011 · cited 77× · PMID 21904575 · DOI 10.1177/1758834010397569
6. The evolving genomic classification of lung cancer.
   Shames DS, Wistuba II. · · 2014 · cited 71× · PMID 24114583 · DOI 10.1002/path.4275
7. From targets to targeted therapies and molecular profiling in non-small cell lung carcinoma.
   Thomas A, Rajan A, Lopez-Chavez A, Wang Y, et al · · 2013 · cited 51× · PMID 23131389 · DOI 10.1093/annonc/mds478
8. Novel clinical trial designs emerging from the molecular reclassification of cancer.
   Nikanjam M, Kato S, Allen T, Sicklick JK, et al · · 2025 · cited 15× · PMID 39841128 · DOI 10.3322/caac.21880