A Study of Alimta/Cisplatin/Gefitnib for Asian Non-smoking Patients With Non Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01017874
First received: November 19, 2009
Last updated: May 2, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare two different approaches to treating non small cell lung cancer in East Asian never-smoker patients. Half of the patients will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti cancer agent (gefitinib) and the other half of the patients will receive only the oral anti cancer agent (gefitinib).
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Pemetrexed Drug: Cisplatin Drug: Gefitinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Ph 3 Study Comparing First-Line Pemetrexed/Cisplatin Followed by Gefitinib With Gefitinib Alone in East Asian Never Smoker or Light Ex-Smoker Patients With Locally Advanced or Metastatic Nonsquamous NSCLC |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Progression free survival [ Time Frame: Every other cycle for 6 cycles then every 6 weeks from the date of randomization to the first date of measured progressive disease or death from any cause ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: Yes ]
- Tumour response rate [ Time Frame: Every other cycle for 6 cycles then every 6 weeks ] [ Designated as safety issue: No ]
- Disease control rate [ Time Frame: Every other cycle for 6 cycles then every 6 weeks ] [ Designated as safety issue: No ]
- Time to progressive disease [ Time Frame: Every other cycle for 6 cycles then every 6 weeks from the date of randomization to the first date of measured progressive disease ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Every other cycle for 6 cycles then every 6 weeks from the date of initial response to the date of measured progressive disease or death from any cause ] [ Designated as safety issue: No ]
- Time to worsening of health-related quality of life (TWQ) (using the patient-rated Lung Cancer Symptom Scale) [ Time Frame: Every cycle while on-study therapy and at 3 months post last dose ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 226 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2014 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed + Cisplatin + Gefitinib |
Drug: Pemetrexed
500 mg/m2 administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Other Names:
Drug: Cisplatin
75 mg/m2 administered intravenously on day 1 of each 21 day cycle, for 6 cycles
Drug: Gefitinib
250 mg administered orally once a day, every day of 21 day cycle, for 6 cycles
|
| Active Comparator: Gefitinib |
Drug: Gefitinib
250 mg administered orally once a day, every day of 21 day cycle, for 6 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
Patients must be "light ex-smokers" or "never-smokers".
- "Light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years.
- "Never-smokers" are defined as having smoked <100 cigarettes or equivalent during his/her lifetime.
- Patients must be of East Asian ethnicity.
- No prior systemic therapy for lung cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Any evidence of clinically active interstitial lung disease. Asymptomatic patients with chronic, stable, radiographic changes are eligible.
- Patients whose Epiderla growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Patients in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017874
Locations
| Hong Kong | |
| 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. | |
| Kowloon, Hong Kong | |
| Korea, Republic of | |
| 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. | |
| Incheon, Korea, Republic of, 405-760 | |
| 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, Korea, Republic of, 110-744 | |
| Singapore | |
| 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. | |
| Singapore, Singapore, 258499 | |
| Taiwan | |
| 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. | |
| Kuei Shan Hsiang, Taiwan, 33305 | |
| 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. | |
| Liouying/Tainan, Taiwan, 736 | |
| 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. | |
| Puzih City, Taiwan, 613 | |
| 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. | |
| Taichung, Taiwan, 407 | |
| 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, Taiwan, 100 | |
| Thailand | |
| 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. | |
| Bangkok, Thailand, 10700 | |
| 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. | |
| Chiang Mai, Thailand, 50200 | |
| 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. | |
| Hat Yai, Thailand, 90110 | |
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
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01017874 History of Changes |
| Other Study ID Numbers: | 13021, H3E-CR-S131 |
| Study First Received: | November 19, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Korea: Food and Drug Administration Taiwan: Department of Health Singapore: Health Sciences Authority Malaysia: Ministry of Health Thailand: Ethical Committee China: Food and Drug Administration Hong Kong: Department of Health |
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 Gefitinib |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013