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

• ClinicalTrials.gov Identifier: NCT00391274
• Recruitment Status: Completed
• First Posted: October 23, 2006
• Results First Posted: March 30, 2010
• Last Update Posted: April 12, 2011
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed; Drug: docetaxel	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
• Study Start Date: October 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: June 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pemetrexed	Drug: pemetrexed; 500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment; Other Names: LY231514; Alimta
Active Comparator: Docetaxel	Drug: docetaxel; 75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment

Outcome Measures

Primary Outcome Measures :

1. Overall Survival [ Time Frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment) ]
   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.

Secondary Outcome Measures :

1. Overall Tumor Response [ Time Frame: baseline to measured tumor response (up to 24 months after study enrollment) ]
   Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
2. Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 24 months after study enrollment) ]
   Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
3. Duration of Response [ Time Frame: time of response to progressive disease (up to 24 months) ]
   Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
4. Pharmacology Toxicity [ Time Frame: first dose of study drug up to 24 months ]
   Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

China

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, China, 101149

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.

Guang Zhou, China, 510080

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.

Hang Zhou, China, 310022

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.

Nan Jing, China, 210002

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, China, 200433

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, China, 300060

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.

Wu Han, China, 430030

Sponsors and Collaborators

Eli Lilly and Company

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:

Lilly Clinical Trial Registry 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Chief Medical Officer, Eli Lilly
• ClinicalTrials.gov Identifier: NCT00391274
• Other Study ID Numbers: 10717; H3E-MC-JMID ( Other Identifier: Eli Lilly and Company )
• First Posted: October 23, 2006
• Results First Posted: March 30, 2010
• Last Update Posted: April 12, 2011
• Last Verified: April 2011

Additional relevant MeSH terms:

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; Docetaxel; Pemetrexed; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors