A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

NCT01005680 | Completed Phase 3 Results

• 2 other identifiers: 12878H3E-CR-JMIL
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to compare the efficacy and safety of two different chemotherapy types in the first line treatment of advanced Non-Small Cell Lung Cancer (NSCLC).

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as the duration from date of randomization to date of death from any cause. Participants who were alive were censored at the date of last contact.

  Randomization to date of death from any cause up to 35.8 months post-randomization

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization

• Time to Progressive Disease (TtPD)

  Randomization to first date of PD up to 23.7 months post-randomization

• Duration of Response (DoR)

  Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization

• Time to Treatment Failure (TtTF)

  Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization

• Tumor Response Rate

  Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization

Other Outcomes (2)

• Disease Control Rate (DCR)

  Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization

• Survival Without Toxicity (SWT)

  Randomization to date of toxicity or date of death up to 34.6 months post-randomization

Study Arms (2)

Pemetrexed plus Cisplatin

EXPERIMENTAL

Drug: Pemetrexed; Drug: Cisplatin

Gemcitabine plus Cisplatin

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: Cisplatin

Interventions

Pemetrexed DRUG

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

Also known as: Alimta, LY231514

Pemetrexed plus Cisplatin

Gemcitabine DRUG

1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles

Also known as: Gemzar, LY188011

Gemcitabine plus Cisplatin

Cisplatin DRUG

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

Gemcitabine plus Cisplatin; Pemetrexed plus Cisplatin

Eligibility Criteria

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

You may qualify if:

• Present with histologically proven or cytological diagnosis of non-squamous non-small cell lung cancer (NSCLC) Stage IIIB or IV.
• Participants must agree to use a reliable method of birth control during the study and for 3 months following the last dose of study drug.
• Female participants must not be pregnant.
• No prior systemic chemotherapy for lung cancer.
• At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Adequate organ function.
• Prior radiation therapy allowed to \<25% of the bone marrow.
• Signed informed consent document on file.
• Estimated life expectancy of greater than or equal to 12 weeks.
• Participant compliance and geographic proximity that allow adequate follow up.

You may not qualify if:

• Peripheral neuropathy of great than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
• Inability to comply with protocol or study procedures.
• A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
• Documented brain metastases unless the participant has completed successful local therapy for central nervous system metastases and has not taken corticosteroids for at least 4 weeks before enrollment.
• Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
• Significant weight loss (that is, greater than or equal to 10%) over the previous 6 weeks before study entry.
• Concurrent administration of any other anti-tumor therapy.
• Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents, such as piroxicam).
• Inability or unwillingness to take folic acid or vitamin B12 supplementation.
• Inability to take corticosteroids.
• Pregnant or breast-feeding.
• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (8)

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, 100730, 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.

Changchun, 130012, 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.

Dalian, 116023, 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.

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.

Nanning, 530000, 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.

Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Gemcitabine; Cisplatin

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

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: October 29, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-10

Locations

CN (8)