Spots Global Cancer Trial Database for Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
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Trial Identification
Brief Title: Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
Official Title: A Randomized Phase III Trial of Erlotinib Versus Docetaxel in Patients With Advanced Squamous Cell Non-small Cell Lung Cancer Who Failed First Line Platinum Based Doublet Chemotherapy Stratified by VeriStrat Good vs VeriStrat Poor
Study ID: NCT01652469
Conditions
Study Description
Brief Summary: Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.
Detailed Description: Goals of the study: 1. Explore the predictive ability of the VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (VSG vs VSP) using as outcome progression free survival. 2. Explore whether treatment with erlotinib provides progression free survival benefit as compared to docetaxel in the VSG group. 3. Compare progression free survival in the two treatment arms (Arm A: erlotinib vs Arm B: docetaxel) in the VSP group. 4. Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in progression free survival between the two VeriStrat groups (in case of no significant interaction). 5. Explore the predictive ability of the VeriStrat signature using the secondary measures of clinical efficacy including overall survival, objective response rate, and disease control rate. 6. Compare overall survival, objective response rate and disease control rate between treatment groups separately in the VSG and VSP groups. 7. Explore the prognostic ability of the VeriStrat signature by testing for an overall difference in overall survival, objective response rate and disease control rate between the two VeriStrat groups (in case of no significant interaction). 8. Assess the safety and the tolerability of the two treatments separately in each VeriStrat group and overall. Recruitment period: 18 months Sample Size: 500
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Krankenhaus Hietzing, Wien, , Austria
Institut Jules Bordet, Brussels, , Belgium
Aarhus University Hospital, Aarhus, , Denmark
University Hospital of Heraklion, Heraklion, , Greece
National Institute of Oncology, Budapest, , Hungary
St James's Hospital, Dublin, , Ireland
Institution Rabin MC, Petah Tikwa, , Israel
Tel-Aviv Medical Center, Tel-Aviv, , Israel
Medical Oncology, Second University Naples, Naples, , Italy
Vercelli Teaching Hospital, Vercelli, , Italy
Free University Medical Center, Amsterdam, , Netherlands
Hospital general de Alicante, Alicante, , Spain
Hospital Clínic Barcelona, Barcelona, , Spain
Institut Català d'Oncologia - L'Hospitalet, Barcelona, , Spain
Ciudad Real General University Hospital, Ciudad Real, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Onkologikoa, Donostia, , Spain
Hospital Severo Ochoa, Leganés, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Carlos Haya Hospital, Malaga, , Spain
Hospital Universitari Sant Joan, Reus, , Spain
Hospital Arnau Vilanova Valencia, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
University Hospital Basel, Basel, , Switzerland
Kantonsspital Graubünden, Chur, , Switzerland
Fondation du centre Pluridisciplinaire d'Oncologie (CePO), Lausanne, , Switzerland
Kantonsspital Luzern, Luzern, , Switzerland
Onkologiezentrum Berner Oberland, Thun, , Switzerland
Universitätsspital Zürich, Zürich, , Switzerland
University Hospital South Manchester, Manchester, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Contact Details
Name: Solange Peters, MD-PhD
Affiliation: Centre Pluridisciplinaire d'Oncologie, Centre Hospitalier Universitaire Vaudois, 1011 Lausanne, Switzerland
Role: STUDY_CHAIR
Name: Egbert Smit, MD-PhD
Affiliation: Vrije Universiteit VU, Medical Centre, 1007MB Amsterdam, The Netherlands
Role: STUDY_CHAIR
Name: Rolf Stahel, MD
Affiliation: Laboratory of Molecular Oncology, Clinic of Oncology, University Hospital Zürich, 8044 Zürich, Switzerland
Role: STUDY_CHAIR
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