22IN - Overview of trials testing tumour molecular profiling

Date 28 September 2014
Event ESMO 2014
Session Molecular profiling: Challenges and perspectives
Topics Clinical Research
Pathology/Molecular Biology
Translational Research
Basic Scientific Principles
Basic Principles in the Management and Treatment (of cancer)
Presenter Jean-Charles Soria
Citation Annals of Oncology (2014) 25 (suppl_4): iv9-iv10. 10.1093/annonc/mdu294
Authors J. Soria
  • Dept. Of Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif CEDEX/FR




The feasibility to incorporate molecular screening approaches based on highthroughput technologies in cancer patients is now clearly established and is tested across prospective trials around the world. Such trials can be divided in 2 main groups: 1) First generation trials which are molecular triage trials without randomization and frequently without a build-in approach to gain access to the ad hoc molecular targeted therapies. 2) Second generation trials that encompass within the trial the access to targeted therapies, a randomization component and usually test the relevance of a new algorithm rather than the efficacy of a given compound and matched abnormality SAFIR01 is one of main prospective first-generation precision medicine trial ever conducted in breast cancer and demonstrated not only the feasibility of such an approach but also the high interest of patients and the potential associated benefit for patients with specific molecular alterations of FGFR/EGFR or PI3K pathway (Andre F et al. The Lancet Oncology 2014). The table herebelow provides a non-exhaustive list of some of the ongoing trials.

Trial or program name and origin Genomics analysis technics Cancer types Clinical trial reference
SHIVACurie Institute, Paris, France IonTorrent/PGM (Amplicon sequencing) + CytoscanHD Solid tumors NCT01771458
MOSCATOGustave Roussy, Villejuif, France IonTorrent/PGM* (Amplicons sequencing) CGHa (WG) Solid tumors eligible for Phase I trials NCT01566019
SAFIR02Gustave Roussy, Villejuif, France IonTorrent/PGM (Amplicons sequencing) + CGHa (WG) Breast metastatic Cancer or lung cancer NCT02117167
IMPACTMD Anderson Cancer Center, Houston, US Targeted – HostSpot (PCR based and FISH) Solid tumors NCT00851032
IMPACTPrincess Margaret Cancer Centre, Toronto, Canada Targeted - Host Spot (Sequanom) – MiSeq (sequence) Selected Solid Tumors NCT01505400
WINTHERWIN Consortium, Inernational Fondation On - CGHa - Whole Transcriptome Solid tumors NCT01856296
Battle-2MD Anderson Cancer Center, Houston, US Targeted - Host spot (PCR-based and FISH) NSCLC, PD on chemotherapy NCT01248247
IMAGE StudyJohns Hopkins, Baltimore, US NGS (Foundation One) Metastatic Breast Cancer NCT01939847


The author has declared no conflicts of interest.