A Study of PC Sequential Pemetrexed Single Drug Maintenance Treatment for NSCLC and Related Predictive Biomarkers

Fudan University

Status: Unknown

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: pemetrexed /carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01860508

2013-PEM-WJL

Details and patient eligibility

About

PFS

Enrollment: 94 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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94 participants in 1 patient group

pemetrexed

Experimental group

Treatment:

Drug: pemetrexed /carboplatin