Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

NCT00391274 | Completed Phase 3 Results

• 2 other identifiers: 10717H3E-MC-JMID
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.

  baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment)

Secondary Outcomes (4)

• Overall Tumor Response

  baseline to measured tumor response (up to 24 months after study enrollment)

• Progression-Free Survival (PFS)

  baseline to measured progressive disease (up to 24 months after study enrollment)

• Duration of Response

  time of response to progressive disease (up to 24 months)

• Pharmacology Toxicity

  first dose of study drug up to 24 months

Study Arms (2)

Pemetrexed

EXPERIMENTAL

Drug: pemetrexed

Docetaxel

ACTIVE COMPARATOR

Drug: docetaxel

Interventions

pemetrexed DRUG

500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment

Also known as: LY231514, Alimta

Pemetrexed

docetaxel DRUG

75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment

Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
• At least one prior chemotherapy for palliative therapy
• Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

You may not qualify if:

• Concurrent administration of any other tumor therapy
• Pregnant or breast feeding
• Serious concomitant disorders
• Inability or unwillingness to take folic acid or vitamin B12 supplementation

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

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.

Beijing, 101149, China

Location

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.

Guangzhou, 510080, China

Location

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.

Hangzhou, 310022, China

Location

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.

Nanjing, 210002, China

Location

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.

Shanghai, 200433, China

Location

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.

Tianjin, 300060, China

Location

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.

Wuhan, 430030, China

Location

Related Publications (2)

• Wu YL, Sun Y, Zhou CC, Zhang L, Yu SY, Ma SL, Han LL, Zhang XQ, Orlando M. Survival without common toxicity criteria grade 3/4 toxicity following second-line treatment with pemetrexed for nonsquamous non-small cell lung cancer in Chinese patients. Chin Med J (Engl). 2013;126(24):4624-8.

  PMID: 24342300 DERIVED

• Sun Y, Wu YL, Zhou CC, Zhang L, Zhang L, Liu XY, Yu SY, Jiang GL, Li K, Qin SK, Ma SL, Han L, Quinlivan M, Orlando M, Zhang XQ. Second-line pemetrexed versus docetaxel in Chinese patients with locally advanced or metastatic non-small cell lung cancer: a randomized, open-label study. Lung Cancer. 2013 Feb;79(2):143-50. doi: 10.1016/j.lungcan.2012.10.015. Epub 2012 Nov 20.

  PMID: 23182660 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

The primary outcome measure of this trial was designed to include pooled data. In addition, the results for the outcome on Duration of Response could not be presented due to the low number of patients being analyzed in the docetaxel group.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 23, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2010
• Last Updated: April 12, 2011
• Results First Posted: March 30, 2010

Record last verified: 2011-04

Locations

CN (7)