Clinical trial NCT01005680: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization to date of death from any cause up to 35.8 months post-randomization
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization
measure: Time to Progressive Disease (TtPD)
timeFrame: Randomization to first date of PD up to 23.7 months post-randomization
measure: Duration of Response (DoR)
timeFrame: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization
measure: Time to Treatment Failure (TtTF)
timeFrame: 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
measure: Tumor Response Rate
timeFrame: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization
measure: Risk/Benefit Ratio
timeFrame: Randomization to date of death from any cause up to 35.8 months post-randomization
Other outcomes:
measure: Disease Control Rate (DCR)
timeFrame: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization
measure: Survival Without Toxicity (SWT)
timeFrame: Randomization to date of toxicity or date of death up to 34.6 months post-randomization
Locations:
city: Beijing
country: China
facility: 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: Changchun
country: China
facility: 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: Dalian
country: China
facility: 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: Guang Zhou
country: China
facility: 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: Nanjing
country: China
facility: 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: Nanning
country: China
facility: 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: Shanghai
country: China
facility: 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: Sichuan
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: