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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


N/A
70 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


Inclusion Criteria:



.≥70 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS

Outcome Time Frame:

from the first cycle of treatment (day one) to two month after the last cycle

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

2013-PEM-WJL

NCT ID:

NCT01860508

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Progression free Survival
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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