Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

NCT00409006 | Completed Phase 2 Results

• 2 other identifiers: 10918H3E-AA-S110
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 7

Brief Summary

The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Defined as the time from randomization to the first observation of disease progression, or death due to any cause.

  Baseline to first observation of disease progression or death, 12 weeks up to 31 months

Secondary Outcomes (3)

• Number of Participants With Tumor Response

  Baseline to measured response or death, 12 weeks up to 31 months

• Duration of Response for Responders

  Time of response to progressive disease or death, 12 weeks up to 31 months

• Overall Survival

  Baseline to date of death from any cause, 12 weeks up to 31 months

Study Arms (2)

Pemetrexed/Cisplatin/Gefitinib

EXPERIMENTAL

Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.

Drug: Pemetrexed; Drug: Cisplatin; Drug: Gefitinib

Pemetrexed/Cisplatin

EXPERIMENTAL

Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.

Drug: Pemetrexed; Drug: Cisplatin

Interventions

Pemetrexed DRUG

500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity.

Also known as: LY231514, Alimta

Pemetrexed/Cisplatin; Pemetrexed/Cisplatin/Gefitinib

Cisplatin DRUG

75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity

Pemetrexed/Cisplatin; Pemetrexed/Cisplatin/Gefitinib

Gefitinib DRUG

250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity

Pemetrexed/Cisplatin/Gefitinib

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 non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
• Have not received any prior chemotherapy, molecular therapy, immunotherapy, biological therapy, or radiotherapy. Exception: palliative radiotherapy that is completed at least 4 weeks prior to study enrolment.
• Have 'never smoked' (defined as having smoked \<100 cigarettes during his/her lifetime)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

You may not qualify if:

• Concurrent administration of any other tumor therapy
• Other co-existing malignancies
• Pregnancy 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.

Fujian, 350014, 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.

Qingdao, 266003, 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, 201900, 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.

Seoul, 137-701, South Korea

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.

Changhua, 500, Taiwan

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.

Taipei, 100, Taiwan

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.

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Ahn MJ, Yang JC, Liang J, Kang JH, Xiu Q, Chen YM, Blair JM, Peng G, Linn C, Orlando M. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Aug;77(2):346-52. doi: 10.1016/j.lungcan.2012.03.011. Epub 2012 Apr 23.

  PMID: 22534669 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Gefitinib

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Quinazolines

Limitations and Caveats

Median overall survival cannot be estimated due to the high censor rate (25 participants per treatment group were censored). Most participants were still living at the end of the study.

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 8, 2006
• Study Start: February 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: May 1, 2010
• Last Updated: September 9, 2010
• Results First Posted: September 9, 2010

Record last verified: 2010-08

Locations

KR (1); TW (3); CN (3)