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

Primary Purpose

Non Small Cell Lung Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Pemetrexed

Gemcitabine

Cisplatin

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pemetrexed plus Cisplatin

Gemcitabine plus Cisplatin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression Free Survival (PFS)

PFS was defined as the date of randomization to date of first observation of clinical or objective progressive disease (PD) or death due to any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of one or more new lesions. Participants who were not known to have died or had PD were censored at the date of last contact.

Time to Progressive Disease (TtPD)

TtPD defined as the time from study randomization to the first date of progressive disease (PD). PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who were not known to have PD or who died without PD were censored at the date of last of last tumor assessment.

Duration of Response (DoR)

DoR was defined as the time from first objective status assessment of complete response (CR) or partial response (PR) to the first time progressive disease (PD) or death as a result of any cause. Response using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Participants who are not known to have died or to have PD were censored at the date of last contact. PD assessed using RECIST v1.0 and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions

Time to Treatment Failure (TtTF)

TtTF was defined as date of randomization until the date of discontinuation of study treatment due to adverse event, progressive disease (PD), or death from any cause. PD assessed using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions. Participants who discontinued study treatment for any other reason were censored at the date of discontinuation of study treatment. Participants still on study drug at data-inclusion cut-off date were censored at the cut-off date.

Tumor Response Rate

Tumor response rate was the percentage of participants with confirmed best tumor response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumor (RECIST v1.0) criteria. Complete Response (CR) was defined as the disappearance of all target lesions; Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions. Progressive disease (PD) assessed using RECIST v1.0 criteria and defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions.

Risk/Benefit Ratio

Risk/benefit ratio was calculated as the percentage of participants who experienced a study-drug related toxicity of Common Terminology Criteria for Adverse Events (CTCAE v3.0) Cancer Therapy Evaluation Program (CTEP) Grade 3 or higher, divided by the Kaplan-Meier estimated percentage of participants surviving one year.

Full Information

NCT ID

NCT01005680

First Posted

October 29, 2009

Last Updated

October 18, 2013

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01005680

Brief Title

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

Official Title

A Randomized Phase 3 Study Comparing Pemetrexed Plus Cisplatin With Gemcitabine Plus Cisplatin as First-Line Treatment in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pemetrexed plus Cisplatin

Arm Type

Experimental

Arm Title

Gemcitabine plus Cisplatin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Other Intervention Name(s)

Alimta, LY231514

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar, LY188011

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

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

Title

Time to Progressive Disease (TtPD)

Description

Time Frame

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

Title

Duration of Response (DoR)

Description

Time Frame

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

Title

Time to Treatment Failure (TtTF)

Description

Time Frame

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

Title

Tumor Response Rate

Description

Time Frame

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

Title

Risk/Benefit Ratio

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Disease Control Rate (DCR)

Description

DCR was the percentage of participants with Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Response determined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0) criteria. CR was defined as the disappearance of all target lesions; PR was defined as at least a 30% decrease in sum of longest diameter of target lesions; progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or the appearance of 1 or more new lesions; SD was defined as small changes that did not meet the above criteria.

Time Frame

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

Title

Survival Without Toxicity (SWT)

Description

SWT was defined as the time from randomization to a study-drug related toxicity. Toxicity was defined as Common Terminology Criteria for Adverse Events (CTCAE v3.0) Grade 3 or 4 or death. Participants who do not have a CTCAE Grade 3 or higher toxicity and are alive will be censored at the date of last contact.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

City

Changchun

ZIP/Postal Code

130012

Country

China

Facility Name

City

Dalian

ZIP/Postal Code

116023

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510080

Country

China

Facility Name

City

Nanjing

ZIP/Postal Code

210002

Country

China

Facility Name

City

Nanning

ZIP/Postal Code

530000

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

City

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

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

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