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Selected Clinical Trials in Lung Cancer
Clinical Trials List Selected Clinical Trials in Lung Cancer
Clinical Trials List Editor: Corey J. Langer, MD
Status for All Trials as of October 2009: Recruiting Early-Stage Disease Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chairs Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID
CALGB-30506: A Randomized Phase III Trial of Adjuvant Therapy in Early-Stage Non–Small-Cell Lung Cancer Evaluating the Potential Utility of a Genomic Prognostic Model to Identify Patients as Candidates for Adjuvant Chemotherapy Overall survival (OS) at 5 years Cancer and Leukemia Group B, National Cancer Institute David H. Harpole, MD Cancer and Leukemia Group B central office, Ph: 773-702-9171 NCT00863512; Study start: 2009 MAGRIT: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non–Small-Cell Lung Cancer Disease-free survival (DFS) GlaxoSmithKline Study Director: GSK Clinical Trials US GSK Clinical Trials Call Center, Ph: 877-379-3718 NCT00480025; Study start: 2007 ECOG-E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non–Small-Lung Cancer (NSCLC) OS Eastern Cooperative Oncology Group, National Cancer Institute, Southwest Oncology Group, Cancer and Leukemia Group B, National Cancer Institute of Canada Clinical Trials Group, North Central Cancer Treatment Group Heather A. Wakelee, MD; David R. Gandara, MD; Stephen L. Graziano, MD; Charles A. Butts, MD, FRCPC; Alex A. Adjei, MD, PhD Heather Wakelee, MD, protocol chair; Ph: 650-723-9094; 800-756-9000 NCT00324805; Study start: 2007 RADIANT: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non–Small-Cell Lung Carcinoma Who Have EGFR-Positive Tumors DFS OSI Pharmaceuticals Study Director: Julie Horan, OSI Pharmaceuticals OSIP Medical Information, Ph: 800-572-1932; e-mail: [email protected] NCT00373425; Study start: 2006 TASTE: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-Squamous Non–Small-Cell Lung Cancer (NSCLC) Feasibility Intergroupe Francophone de Cancerologie Thoracique Principal Investigators: Jean-Charles Soria, Pr; Marie Wislez, Pr Franck Morin, e-mail: [email protected]; Elodie Amour, e-mail: [email protected] NCT00775385; Study start: 2008 A Randomized, Double-Blind, Placebo-Controlled Phase II-III Multi-Centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-Surgical Disease-Free Survival in Patients With Stage I Non–Small-Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm Phase II: feasibility; Phase III: DFS Intergroupe Francophone de Cancerologie Thoracique Principal Investigator: Benjamin Besse, Dr; Study Director: Jean-Charles Soria, Pr Franck Morin, e-mail: [email protected]; Elodie Amour, e-mail: [email protected] NCT00775307; Study start: 2008
This summary may include the discussion of investigational and/or unlabeled uses of drugs and/or devices that may not be approved by the FDA. Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1525-7304, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA. www.copyright.com 978-750-8400.
Clinical Lung Cancer November 2009
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Selected Clinical Trials in Lung Cancer Status for All Trials as of October 2009: Recruiting Early-Stage Disease (continued) Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
SWOG-S0720: Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non–Small-Cell Lung Cancer (NSCLC) Feasibility of pharmacogenomics-based treatment assignment in the cooperative group setting Southwest Oncology Group, National Cancer Institute Ralph G. Zinner, MD Ph: 713-792-6363 NCT00792701; Study start: 2008
Official Title
STARS: Phase III Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non–Small-Cell Lung Cancer OS (time frame, 3 years) Accuray Incorporated; M. D. Anderson Cancer Center Jack Roth, MD Joanne Davis, PhD; Ph: 248-719-2998; e-mail: [email protected]; Tom Zhang, MD; Ph: 408-716-4753; e-mail: [email protected] NCT00840749; Study start: 2008
Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
Locally Advanced Disease Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chairs Contact Information Clinicaltrials.gov ID
446
| Clinical Lung Cancer
START: A Multi-Center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non–Small-Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease OS EMD Serono Principal Investigator: Frances Shepherd, MD, FRCPC Ph: 800-507-5284 NCT00409188; Study start: 2006 PROCLAIM: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non–Small-Cell Lung Cancer Other Than Predominantly Squamous Cell Histology OS Eli Lilly and Company Study Director: Eli Lilly and Company Ph: 877-285-4559; 317-615-4559 NCT00686959; Study start: 2008 RTOG-0617: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non–Small-Cell Lung Cancer OS Radiation Therapy Oncology Group, National Cancer Institute, North Central Cancer Treatment Group, Cancer and Leukemia Group B Principal Investigator: Jeffrey Bradley, MD; Study Chairs: Steven E. Schild, MD; Jeffrey A. Bogart, MD Jeffrey Bradley, MD; Ph: 314-362-8525 NCT00533949; Study start: 2007
November 2009
Clinical Trials List Editor: Corey J. Langer, MD
Status for All Trials as of October 2009: Recruiting Early-Stage Disease Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chairs Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID
CALGB-30506: A Randomized Phase III Trial of Adjuvant Therapy in Early-Stage Non–Small-Cell Lung Cancer Evaluating the Potential Utility of a Genomic Prognostic Model to Identify Patients as Candidates for Adjuvant Chemotherapy Overall survival (OS) at 5 years Cancer and Leukemia Group B, National Cancer Institute David H. Harpole, MD Cancer and Leukemia Group B central office, Ph: 773-702-9171 NCT00863512; Study start: 2009 MAGRIT: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non–Small-Cell Lung Cancer Disease-free survival (DFS) GlaxoSmithKline Study Director: GSK Clinical Trials US GSK Clinical Trials Call Center, Ph: 877-379-3718 NCT00480025; Study start: 2007 ECOG-E1505: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4cm)-IIIA Non–Small-Lung Cancer (NSCLC) OS Eastern Cooperative Oncology Group, National Cancer Institute, Southwest Oncology Group, Cancer and Leukemia Group B, National Cancer Institute of Canada Clinical Trials Group, North Central Cancer Treatment Group Heather A. Wakelee, MD; David R. Gandara, MD; Stephen L. Graziano, MD; Charles A. Butts, MD, FRCPC; Alex A. Adjei, MD, PhD Heather Wakelee, MD, protocol chair; Ph: 650-723-9094; 800-756-9000 NCT00324805; Study start: 2007 RADIANT: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non–Small-Cell Lung Carcinoma Who Have EGFR-Positive Tumors DFS OSI Pharmaceuticals Study Director: Julie Horan, OSI Pharmaceuticals OSIP Medical Information, Ph: 800-572-1932; e-mail: [email protected] NCT00373425; Study start: 2006 TASTE: Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-Squamous Non–Small-Cell Lung Cancer (NSCLC) Feasibility Intergroupe Francophone de Cancerologie Thoracique Principal Investigators: Jean-Charles Soria, Pr; Marie Wislez, Pr Franck Morin, e-mail: [email protected]; Elodie Amour, e-mail: [email protected] NCT00775385; Study start: 2008 A Randomized, Double-Blind, Placebo-Controlled Phase II-III Multi-Centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-Surgical Disease-Free Survival in Patients With Stage I Non–Small-Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm Phase II: feasibility; Phase III: DFS Intergroupe Francophone de Cancerologie Thoracique Principal Investigator: Benjamin Besse, Dr; Study Director: Jean-Charles Soria, Pr Franck Morin, e-mail: [email protected]; Elodie Amour, e-mail: [email protected] NCT00775307; Study start: 2008
This summary may include the discussion of investigational and/or unlabeled uses of drugs and/or devices that may not be approved by the FDA. Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1525-7304, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA. www.copyright.com 978-750-8400.
Clinical Lung Cancer November 2009
| 445
Selected Clinical Trials in Lung Cancer Status for All Trials as of October 2009: Recruiting Early-Stage Disease (continued) Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
SWOG-S0720: Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non–Small-Cell Lung Cancer (NSCLC) Feasibility of pharmacogenomics-based treatment assignment in the cooperative group setting Southwest Oncology Group, National Cancer Institute Ralph G. Zinner, MD Ph: 713-792-6363 NCT00792701; Study start: 2008
Official Title
STARS: Phase III Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non–Small-Cell Lung Cancer OS (time frame, 3 years) Accuray Incorporated; M. D. Anderson Cancer Center Jack Roth, MD Joanne Davis, PhD; Ph: 248-719-2998; e-mail: [email protected]; Tom Zhang, MD; Ph: 408-716-4753; e-mail: [email protected] NCT00840749; Study start: 2008
Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
Locally Advanced Disease Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title
Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chairs Contact Information Clinicaltrials.gov ID
446
| Clinical Lung Cancer
START: A Multi-Center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non–Small-Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease OS EMD Serono Principal Investigator: Frances Shepherd, MD, FRCPC Ph: 800-507-5284 NCT00409188; Study start: 2006 PROCLAIM: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non–Small-Cell Lung Cancer Other Than Predominantly Squamous Cell Histology OS Eli Lilly and Company Study Director: Eli Lilly and Company Ph: 877-285-4559; 317-615-4559 NCT00686959; Study start: 2008 RTOG-0617: A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non–Small-Cell Lung Cancer OS Radiation Therapy Oncology Group, National Cancer Institute, North Central Cancer Treatment Group, Cancer and Leukemia Group B Principal Investigator: Jeffrey Bradley, MD; Study Chairs: Steven E. Schild, MD; Jeffrey A. Bogart, MD Jeffrey Bradley, MD; Ph: 314-362-8525 NCT00533949; Study start: 2007
November 2009