Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy
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ClinicalTrials.gov Identifier: NCT00533429 |
Recruitment Status :
Completed
First Posted : September 21, 2007
Last Update Posted : February 18, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: enzastaurin Drug: pemetrexed Drug: carboplatin Drug: bevacizumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily until disease progression
Other Name: LY317615 Drug: pemetrexed 500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Other Names:
Drug: carboplatin AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: bevacizumab 15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles |
Placebo Comparator: B |
Drug: pemetrexed
500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Other Names:
Drug: carboplatin AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: bevacizumab 15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: Placebo oral, daily |
- Progression-free survival [ Time Frame: baseline to measured progressive disease ]
- Response rate [ Time Frame: baseline to measured progressive disease ]
- Overall survival [ Time Frame: baseline to date of death from any cause ]
- Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
- Duration of response [ Time Frame: time of response to disease progression ]
- Pharmacology toxicity [ Time Frame: every cycle ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- they or their legal representative must have signed an informed consent document for clinical research
- have laboratory confirmed diagnosis of advanced, nonsquamous cell NSCLC (Stage IIIB or IV disease) which is not curable
- have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
- have measurable disease
- have adequate organ function and estimated life expectancy of 12 weeks
Exclusion Criteria:
- have known CNS disease; major surgery within 28 days; minor surgery within 7 days; serious concommitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
- have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
- have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
- are pregnant or breast-feeding
- are unable to swallow tablets

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533429
United States, Arkansas | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Bentonville, Arkansas, United States, 72712 | |
United States, Illinois | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Chicago, Illinois, United States, 60611 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Galesburg, Illinois, United States, 61401 | |
United States, Indiana | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Bloomington, Indiana, United States, 47403 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Evansville, Indiana, United States, 47714 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Fort Wayne, Indiana, United States, 46815 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Indianapolis, Indiana, United States, 46202 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Lafayette, Indiana, United States, 47904 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Muncie, Indiana, United States, 47303 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
South Bend, Indiana, United States, 46601 | |
United States, Michigan | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Jackson, Michigan, United States, 49201 | |
United States, Nebraska | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Omaha, Nebraska, United States, 68114 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Chief Medical Officer, Eli Lilly |
ClinicalTrials.gov Identifier: | NCT00533429 |
Other Study ID Numbers: |
11398 H6Q-MC-S034 |
First Posted: | September 21, 2007 Key Record Dates |
Last Update Posted: | February 18, 2010 |
Last Verified: | February 2010 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Bevacizumab Carboplatin |
Pemetrexed Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |