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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00533429
First received: September 19, 2007
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of patients with advanced stage non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: enzastaurin
Drug: pemetrexed
Drug: carboplatin
Drug: bevacizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to disease progression ] [ Designated as safety issue: No ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • LY231514
  • Alimta
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:
  • LY231514
  • Alimta
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533429

Locations
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
Sponsors and Collaborators
Eli Lilly and Company
Genentech
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00533429     History of Changes
Other Study ID Numbers: 11398, H6Q-MC-S034
Study First Received: September 19, 2007
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Bevacizumab
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014