- Email: [email protected]
Selected Clinical Trials in Lung Cancer
Clinical Trials List Selected Clinical Trials in Lung Cancer
Clinical Trials Editor: Corey J. Langer, MD
Status of all Trials as of August 2010: Recruiting Unless Otherwise Noted Advanced Non–Small-Cell Lung Cancer Metastatic, Second- or Third-line Disease Official Title
Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of PF-02341066 Versus Standard of Care Chemotherapy (Pemetrexed Or Docetaxel) in Patients With Non–Small-Lung Cancer Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus Progression-free survival Pfizer Pfizer CT.gov Call Center Oncology Clinical Trial Information Service; Ph: 877-369-9753; e-mail: [email protected] NCT00932893; study start: 2009 MISSION: A Phase III, Multi-Center, Placebo-Controlled Trial of Sorafenib (BAY 43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non–Small-Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens Overall survival Bayer Bayer Study Director E-mail: [email protected] NCT00863746; study start: 2009 PFIZER-CAN-NCIC-BR26: A Double-Blind Placebo-Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non–Small-Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease Overall survival NCIC Clinical Trials Group Peter Ellis, MD Peter Ellis, MD; Margaret and Charles Juravinski Cancer Centre; Ph: 905-387-9495, ext. 64602 NCT01000025; study start: 2009 ATTRACT-2: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients with Locally Advanced or Metastatic (Stage IIIb/IV) Non–Small-Cell Lung Cancer (NSCLC) Overall survival Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals; Ph: 800-340-6843 NCT00738387; study start: 2008 LUX-LUNG 5: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Lung Cancer Patients Failing Erlotinib or Gefitinib Overall survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Ph: 800-243-0127; e-mail: [email protected] NCT01085136; study start: February 2010 LUME-Lung 1: Randomised Double Blind Phase III Trial of BIBF 1120 Versus Placebo in Addition to Standard Therapy of Docetaxel in Patients With Advanced NSCLC Progression-free survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Study Coordinator; Ph: 800-243-0127; e-mail: [email protected] NCT00805194; study start: 2008
This article might include the discussion of investigational and/or unlabeled uses of drugs and/or devices that might 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.
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September 2010
Advanced Non–Small-Cell Lung Cancer (continued) Metastatic, Second- or Third-line Disease Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID
Lume Lung 2: A Randomized Double-Blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/Placebo in Advanced or Recurrent Non–Small-Cell Lung Cancer Patients After Failure of First-line Therapy Progression-free survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Study Coordinator; Ph: 800-243-0127; e-mail: [email protected] NCT00806819; study start: 2008
Supportive Care Official Title Primary Endpoints Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID
ML21450: A Randomized, Open-Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non–Small-Cell Lung Cancer Percentage of patients who develop skin rash within 27-36 days of treatment Hoffmann-La Roche Clinical Trials, Hoffmann-La Roche Ph: 888-662-6728 (US only); e-mail: [email protected] NCT00718315; study start: 2009 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced-Stage Non–Small-Cell Lung Cancer Receiving Multi-Cycle Chemotherapy Overall survival Amgen Amgen Amgen Call Center; Ph: 866-572-6436 NCT00858364; study start: 2009 RTOG-0517: Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer Time to development of malignant skeletal-related events Radiation Therapy Oncology Group Michael J. Seider, MD, PhD, FACR Ph: 330-375-3557; e-mail: [email protected] NCT00365105; study start: 2006
Small-Cell Lung Cancer Official Title
Primary Endpoint Sponsor Principal Investigator Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID
IFCT-0802: Randomized Phase II-III Study of Bevacizumab 7.5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy: PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide) Response rate (complete response + partial response) 6 weeks after randomization Intergroupe Francophone de Cancerologie Thoracique Dr. Jean-Louis Pujol Franck Morin; Ph: 33-1-56-81-10-45; e-mail: [email protected] NCT00930891; study start: 2009 CALGB-30610 (RTOG 0538): Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide Overall survival time between 3 treatment arms Cancer and Leukemia Group B Jeffrey A. Bogart, MD; Ritsuko U. Komaki, MD, FACR Jeffrey A. Bogart; Ph: 877-464-8668 NCT00632853; study start: 2008
Clinical Lung Cancer September 2010
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Clinical Trials Editor: Corey J. Langer, MD
Status of all Trials as of August 2010: Recruiting Unless Otherwise Noted Advanced Non–Small-Cell Lung Cancer Metastatic, Second- or Third-line Disease Official Title
Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Director Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsors Study Chair Contact Information Clinicaltrials.gov ID
Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of PF-02341066 Versus Standard of Care Chemotherapy (Pemetrexed Or Docetaxel) in Patients With Non–Small-Lung Cancer Harboring a Translocation or Inversion Event Involving the Anaplastic Lymphoma Kinase (ALK) Gene Locus Progression-free survival Pfizer Pfizer CT.gov Call Center Oncology Clinical Trial Information Service; Ph: 877-369-9753; e-mail: [email protected] NCT00932893; study start: 2009 MISSION: A Phase III, Multi-Center, Placebo-Controlled Trial of Sorafenib (BAY 43-9006) in Patients With Relapsed or Refractory Advanced Predominantly Non Squamous Non–Small-Cell Lung Cancer (NSCLC) After 2 or 3 Previous Treatment Regimens Overall survival Bayer Bayer Study Director E-mail: [email protected] NCT00863746; study start: 2009 PFIZER-CAN-NCIC-BR26: A Double-Blind Placebo-Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non–Small-Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease Overall survival NCIC Clinical Trials Group Peter Ellis, MD Peter Ellis, MD; Margaret and Charles Juravinski Cancer Centre; Ph: 905-387-9495, ext. 64602 NCT01000025; study start: 2009 ATTRACT-2: A Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination With Docetaxel in Second-line Treatment of Patients with Locally Advanced or Metastatic (Stage IIIb/IV) Non–Small-Cell Lung Cancer (NSCLC) Overall survival Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals; Ph: 800-340-6843 NCT00738387; study start: 2008 LUX-LUNG 5: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Lung Cancer Patients Failing Erlotinib or Gefitinib Overall survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Ph: 800-243-0127; e-mail: [email protected] NCT01085136; study start: February 2010 LUME-Lung 1: Randomised Double Blind Phase III Trial of BIBF 1120 Versus Placebo in Addition to Standard Therapy of Docetaxel in Patients With Advanced NSCLC Progression-free survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Study Coordinator; Ph: 800-243-0127; e-mail: [email protected] NCT00805194; study start: 2008
This article might include the discussion of investigational and/or unlabeled uses of drugs and/or devices that might 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.
358
| Clinical Lung Cancer
September 2010
Advanced Non–Small-Cell Lung Cancer (continued) Metastatic, Second- or Third-line Disease Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID
Lume Lung 2: A Randomized Double-Blind Multicenter Phase III Trial of BIBF 1120 Plus Pemetrexed vs. Pemetrexed/Placebo in Advanced or Recurrent Non–Small-Cell Lung Cancer Patients After Failure of First-line Therapy Progression-free survival Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Study Coordinator; Ph: 800-243-0127; e-mail: [email protected] NCT00806819; study start: 2008
Supportive Care Official Title Primary Endpoints Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chair Contact Information Clinicaltrials.gov ID
ML21450: A Randomized, Open-Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non–Small-Cell Lung Cancer Percentage of patients who develop skin rash within 27-36 days of treatment Hoffmann-La Roche Clinical Trials, Hoffmann-La Roche Ph: 888-662-6728 (US only); e-mail: [email protected] NCT00718315; study start: 2009 A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once-Every-3-Weeks in Anemic Subjects With Advanced-Stage Non–Small-Cell Lung Cancer Receiving Multi-Cycle Chemotherapy Overall survival Amgen Amgen Amgen Call Center; Ph: 866-572-6436 NCT00858364; study start: 2009 RTOG-0517: Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer Time to development of malignant skeletal-related events Radiation Therapy Oncology Group Michael J. Seider, MD, PhD, FACR Ph: 330-375-3557; e-mail: [email protected] NCT00365105; study start: 2006
Small-Cell Lung Cancer Official Title
Primary Endpoint Sponsor Principal Investigator Contact Information Clinicaltrials.gov ID Official Title Primary Endpoint Sponsor Study Chairs Contact Information Clinicaltrials.gov ID
IFCT-0802: Randomized Phase II-III Study of Bevacizumab 7.5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy: PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide) Response rate (complete response + partial response) 6 weeks after randomization Intergroupe Francophone de Cancerologie Thoracique Dr. Jean-Louis Pujol Franck Morin; Ph: 33-1-56-81-10-45; e-mail: [email protected] NCT00930891; study start: 2009 CALGB-30610 (RTOG 0538): Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide Overall survival time between 3 treatment arms Cancer and Leukemia Group B Jeffrey A. Bogart, MD; Ritsuko U. Komaki, MD, FACR Jeffrey A. Bogart; Ph: 877-464-8668 NCT00632853; study start: 2008
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