A Study of Alimta/Cisplatin/Gefitinib for Asian Non-smoking Participants With Non Small Cell Lung Cancer

NCT01017874 | Completed Phase 3 Results

• 2 other identifiers: 13021H3E-CR-S131
• Study Type: interventional
• Target: 236
• Locations: 5 countries
• Sites: 12

Brief Summary

The purpose of this study is to compare two different approaches to treating non-small cell lung cancer (NSCLC) in East Asian never-smoker participants. Half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from date of randomization to the objective disease progression or death due to any cause. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Progressive disease (PD) was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions. Participants who did not have a complete baseline disease assessment were censored at the date of randomization, regardless if PD was objectively determined or if participant died or if a participant was not known to have died or have objective PD at the data inclusion cutoff date. PFS was censored at the last complete objective progression-free disease assessment date.

  Randomization to the first date of measured PD or death up to 37.32 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Randomization up to date of death from any cause up to 57.13 months

• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Tumor Response Rate (TRR)]

  Randomization up to 37.52 months

• Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]

  Randomization up to 37.52 months

• Time to Progressive Disease (TtPD)

  Randomization to the first date of measured PD up to 37.32 months

• Duration of Tumor Response

  Date of initial response to the date of measured PD or death up to 34.43 months

Study Arms (2)

Pemetrexed + Cisplatin + Gefitinib

EXPERIMENTAL

Drug: Pemetrexed; Drug: Cisplatin; Drug: Gefitinib

Gefitinib

ACTIVE COMPARATOR

Drug: Gefitinib

Interventions

Pemetrexed DRUG

500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles.

Also known as: Alimta, LY231514

Pemetrexed + Cisplatin + Gefitinib

Cisplatin DRUG

75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

Pemetrexed + Cisplatin + Gefitinib

Gefitinib DRUG

250 milligrams (mg) administered orally once a day, every day of 21-day cycle, for maintenance in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy

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:

• Histological diagnosis of NSCLC with locally advanced or metastatic disease that is of non-squamous histology.
• Participants 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.
• Participants must be of East Asian ethnicity.
• No prior systemic therapy for lung cancer.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• 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 participants with chronic, stable, radiographic changes are eligible.
• Participants whose Epidermal Growth Factor Receptor (EGFR) mutation status is known prior to study entry will be excluded. Participants in which EGFR mutation testing has not been performed, or whose EGFR mutation status is unknown or inconclusive at study entry are eligible.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (12)

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

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.

Singapore, 258499, Singapore

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.

Incheon, 405-760, 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.

Seoul, 110-744, 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.

Kuei Shan Hsiang, 33305, 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.

Liouying/Tainan, 736, 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.

Puzih City, 613, 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.

Taichung, 407, 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.

Bangkok, 10700, Thailand

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.

Chiang Mai, 50200, Thailand

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.

Hat Yai, 90110, Thailand

Location

Related Publications (3)

• Yang JC, Srimuninnimit V, Ahn MJ, Lin CC, Kim SW, Tsai CM, Mok T, Orlando M, Puri T, Wang X, Park K. First-Line Pemetrexed plus Cisplatin followed by Gefitinib Maintenance Therapy versus Gefitinib Monotherapy in East Asian Never-Smoker Patients with Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer: Final Overall Survival Results from a Randomized Phase 3 Study. J Thorac Oncol. 2016 Mar;11(3):370-9. doi: 10.1016/j.jtho.2015.11.008. Epub 2015 Dec 25.

  PMID: 26725183 DERIVED

• Kang JH, Ahn MJ, Kim DW, Cho EK, Kim JH, Shin SW, Wang X, Kim JS, Orlando M, Park K. Tolerability and Outcomes of First-Line Pemetrexed-Cisplatin Followed by Gefitinib Maintenance Therapy Versus Gefitinib Monotherapy in Korean Patients with Advanced Nonsquamous Non-small Cell Lung Cancer: A Post Hoc Descriptive Subgroup Analysis of a Randomized, Phase 3 Trial. Cancer Res Treat. 2016 Apr;48(2):458-64. doi: 10.4143/crt.2015.135. Epub 2015 Oct 14.

  PMID: 26511807 DERIVED

• Yang JC, Kang JH, Mok T, Ahn MJ, Srimuninnimit V, Lin CC, Kim DW, Tsai CM, Barraclough H, Altug S, Orlando M, Park K. First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in East Asian patients with locally advanced or metastatic non-squamous non-small cell lung cancer: a randomised, phase 3 trial. Eur J Cancer. 2014 Sep;50(13):2219-30. doi: 10.1016/j.ejca.2014.05.011. Epub 2014 Jun 18.

  PMID: 24953333 DERIVED

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

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: November 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2014
• Last Updated: July 8, 2015
• Results First Posted: April 3, 2014

Record last verified: 2015-06

Locations

TW (5); SG (1); KR (2); TH (3); HK (1)