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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01860508
Enrollment
94
Registered
2013-05-22
Start date
2013-02-28
Completion date
Unknown
Last updated
2013-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Progression free Survival

Brief summary

PFS

Interventions

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

.≥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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
PFSfrom the first cycle of treatment (day one) to two month after the last cycle

Countries

China

Contacts

Primary ContactJia lei Wang, Master
luwangjialei@hotmail.com02164175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026