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

Not Applicable

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: pemetrexed /carboplatin

• Registration Number: NCT01860508
• Lead Sponsor: Fudan University

Brief Summary

PFS

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pemetrexed	pemetrexed /carboplatin	-

Primary Outcome Measures

Name	Time	Method
PFS	from the first cycle of treatment (day one) to two month after the last cycle

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China