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COMBINATION TRIALS

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Regimen 1

Drug Therapy:
• Pemetrexed (Alimta)
• Cisplatin

Regimen 2

Drug Therapy:
• Gemcitabine (Gemzar)
• Cisplatin

Participating Institution Multicenter, international (USA=18, ROW=116)
• Medical Center University of Mannheim, Germany
• Nizam's Institute of Medical Sciences (Hyderabad, India)
• National Cancer Institute-Brazil, Clinical Oncology, Rio de Janeiro, Brazil
• San Camillo-Forlanini Hospitals (Rome, Italy)
• Herlev University Hospital, Denmark
• UC Davis Cancer Center (Sacramento, CA)
• Hospital Grosshansdorf, Germany
• University of Torino (Orbassano, Italy)
• Samsung Medical Center (Seoul, Korea)
• Bangalore Institute of Oncology (Bangalore, India)
• Oncological Institute (Krakow, Poland)
• Ege University Medical School (Izmir, Turkey)
• St. Jansdal Hospital (Harderwijk, The Netherlands)
• University of Washington (Seattle, WA)

Cancer Indication lung cancer

Clinical Indication non-small cell lung cancer (nsclc), locally advanced or metastatic, first line

Clinical Status Phase III (begin 7/04, closed 12/05, completed 3/08) USA, Argentina, Australia, Brazil, Canada, Europe (Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK) India, Israel, Korea, Mexico, Taiwan, Turkey

Clinical Trial Title A Phase III Clinical Trial of Pemetrexed and Cisplatin Compared to Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Objective This was a non-inferiority trial whose primary outcome measure was to compare pemetrexed plus cisplatin with gemcitabine plus cisplatin in terms of OS in previously untreated patients with locally advanced (Stage IIIb not amenable to curative treatment) or mestatic (Stage IV) non-small cell lung cancer (nsclc). Secondary objectives include PFS, TTP, duration of response, and time to treatment failure.

Protocol ID 2938; H3E-MC-JMDB; NCT00087711

Protocol Link Link to Protocol

Protocol Description
According to the protocol, in arm 1 (AC regimen), patients are treated with IV pemetrexed (500 mg/m2) and IV cisplatin (75 mg/m²) on day 1, every 21 days for 6 cycles. In arm 2 (GC regimen), patients are treated with IV gemcitabine (1250 mg/m²) on day 1 and 8 every 21 days for 6 cycles, in combination with cisplatin as in arm 1. Patients in both arms were administered dexamethasone prophylaxis, folic acid, and vitamin B12 supplementation.

Biomarkers Over 200 formalin-fixed paraffin-embedded (FFPE) tissue samples were collected for mRNA, protein expression and analysis of correlations between biomarker expression and clinical outcomes.

Enrollment 1725 patients (Stage IV=76%; PC=862, GC= 863)

Toxicity Hematologic Grade 3/4 drug-related toxicities were significantly (p = 0.001) lower with the PC regimen, including neutropenia (15% versus 27%), anemia (6% versus 10%), and thrombocytopenia (4% versus 13%). Incidence of alopecia (12% versus 21%), and Grade 3/4 febrile neutropenia (1% versus 4%, p=0.002) were significantly lower with PC (p< 0.001). There was less Grade 3/4 nausea (7% versus 4%, p=0.004) and anorexia (2% versus 1%, p=0.009) with GC. However, there was no significant difference in weight loss (any grade) between arms.

Interim Results

Result Summary OS for patients randomized to PC was non-inferior to those on GC (10.3 months versus 10.3 months) for an HR of 0.94). PC retains at least 83% of GC survival benefit. PFS and response rates similarly reflected robust non-inferiority for PC versus GC (4.8 months versus 5.1 months) for an HR of 1.04, and 31% versus 28%.

Result - Overall Response PC=31%; GC=28%

Result - PFS PC=4.8 months; GC=5.1 months

Author's Conclusions For first ine treatment of advanced nsclc, the pemetrexed plus cispaltin regimen provides similar efficacy with better tolerability and more convenient administration than gemcitabine and cisplatin.

Reference Scagliotti1 G, etal, ECO07, Abs. O#6519; Manegold C, etal, ECCO07, Abs. 1BA#

Current as of October 13, 2008

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Cancer Indication	lung cancer
Clinical Indication	non-small cell lung cancer (nsclc), locally advanced or metastatic, first line
Clinical Status	Phase III (begin 7/04, closed 12/05, completed 3/08) USA, Argentina, Australia, Brazil, Canada, Europe (Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK) India, Israel, Korea, Mexico, Taiwan, Turkey
Clinical Trial Title	A Phase III Clinical Trial of Pemetrexed and Cisplatin Compared to Gemcitabine and Cisplatin in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Clinical Trial Objective	This was a non-inferiority trial whose primary outcome measure was to compare pemetrexed plus cisplatin with gemcitabine plus cisplatin in terms of OS in previously untreated patients with locally advanced (Stage IIIb not amenable to curative treatment) or mestatic (Stage IV) non-small cell lung cancer (nsclc). Secondary objectives include PFS, TTP, duration of response, and time to treatment failure.
Protocol ID	2938; H3E-MC-JMDB; NCT00087711
Protocol Link	Link to Protocol
Protocol Description	According to the protocol, in arm 1 (AC regimen), patients are treated with IV pemetrexed (500 mg/m2) and IV cisplatin (75 mg/m²) on day 1, every 21 days for 6 cycles. In arm 2 (GC regimen), patients are treated with IV gemcitabine (1250 mg/m²) on day 1 and 8 every 21 days for 6 cycles, in combination with cisplatin as in arm 1. Patients in both arms were administered dexamethasone prophylaxis, folic acid, and vitamin B12 supplementation.
Biomarkers	Over 200 formalin-fixed paraffin-embedded (FFPE) tissue samples were collected for mRNA, protein expression and analysis of correlations between biomarker expression and clinical outcomes.
Enrollment	1725 patients (Stage IV=76%; PC=862, GC= 863)
Toxicity	Hematologic Grade 3/4 drug-related toxicities were significantly (p = 0.001) lower with the PC regimen, including neutropenia (15% versus 27%), anemia (6% versus 10%), and thrombocytopenia (4% versus 13%). Incidence of alopecia (12% versus 21%), and Grade 3/4 febrile neutropenia (1% versus 4%, p=0.002) were significantly lower with PC (p< 0.001). There was less Grade 3/4 nausea (7% versus 4%, p=0.004) and anorexia (2% versus 1%, p=0.009) with GC. However, there was no significant difference in weight loss (any grade) between arms.
Interim Results
Result Summary	OS for patients randomized to PC was non-inferior to those on GC (10.3 months versus 10.3 months) for an HR of 0.94). PC retains at least 83% of GC survival benefit. PFS and response rates similarly reflected robust non-inferiority for PC versus GC (4.8 months versus 5.1 months) for an HR of 1.04, and 31% versus 28%.
Result - Overall Response	PC=31%; GC=28%
Result - PFS	PC=4.8 months; GC=5.1 months
Author's Conclusions	For first ine treatment of advanced nsclc, the pemetrexed plus cispaltin regimen provides similar efficacy with better tolerability and more convenient administration than gemcitabine and cisplatin.
Reference	Scagliotti1 G, etal, ECO07, Abs. O#6519; Manegold C, etal, ECCO07, Abs. 1BA#
Current as of	October 13, 2008