A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers
Advanced Metastatic Non-small Cell Lung Cancer Patients Aged or PS Score 2 Points for First Line Application Pemetrexed/Carboplatin Chemotherapy Regimens Sequential Pemetrexed Single Drug Maintenance Treatment of Clinical Research and Related Predictive Biomarkers of Exploratory Research
1 other identifier
interventional
94
1 country
1
Brief Summary
PFS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 20, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedJuly 8, 2013
July 1, 2013
1 year
May 20, 2013
July 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PFS
from the first cycle of treatment (day one) to two month after the last cycle
Study Arms (1)
pemetrexed
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ≥65 years or PS 2
- Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
- Patients received no chemical therapy or only received targeted therapy,and there is evidence show the patent is PD
- Presence of at least one index lesion measurable by CT scan or MRI
- leucocyte ≥ 3.5×109/L
- neutrophil ≥ 1.5×109/L
- platelet ≥ 80×109/L
- Hemoglobin ≥ 9g/L
- ALT and AST ≤ 2.5×ULN ,Tbil≤ 1.5×ULN
- BUN≤ 1.5×ULN
- Signed written informed consent
You may not qualify if:
- squamous carcinoma or small cell lung cancer
- Patients were allergic to pemetrexed
- Patients received chemotherapy before
- Uncontrolled acute infection
- Uncontrolled pleural effusion
- Severe symptomatic heart disease
- Severe infection or metabolic disfunction
- Patients with other malignant tumor
- Uncontrolled brain metastases
- Patients have accepted other clinical trials
- Female patients during their pregnant and lactation period, or patients without contraception
- Mental disorientation of disorder
- Glucocorticoids taboo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Zhao X, Yu H, Zhao J, Wu X, Sun S, Luo Z, Wang H, Qiao J, Chang J, Wang J. Efficacy and safety of first-line pemetrexed plus carboplatin followed by single-agent pemetrexed maintenance in elderly Chinese patients with non-squamous non-small-cell lung cancer. Oncotarget. 2017 Sep 23;8(49):86384-86394. doi: 10.18632/oncotarget.21186. eCollection 2017 Oct 17.
PMID: 29156802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending doctor of medical oncology
Study Record Dates
First Submitted
May 20, 2013
First Posted
May 22, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Last Updated
July 8, 2013
Record last verified: 2013-07