CClinicalTrials.gg
Status unknownNCT01192243Updated Sep 3, 2010

Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small Cell Lung Cancer Patients

A Phase 2 interventional study of Gefitinib and Pemetrexed in Toxicity and Non-small Cell Lung Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-09-03.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to examine the efficacy and safety of gefitinib combinated with Pemetrexed/Cisplatin in advanced non-small cell lung cancer (NSCLC).

02

Conditions studied

  • Toxicity
  • Non-small Cell Lung Cancer

Keywords

  • Objective response rate
  • Time to Progression
  • Quality of Live
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 68 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who were diagnosed by the histologic, cytologic diagnosis of IV non-small cell lung cancer
  • Age from 18 to 70 years old
  • At least one target lesion diameter spiral CT ≥ 1 cm, or the common CT ≥ 2 cm, and can be measured by imaging tools
  • ECOG 0-1
  • Expected life time longer than 12 weeks
  • Normal laboratory values:

leucocyte≥ 4×109/L neutrophil≥ 1.5×109/L platelet≥100×109/L Hemoglobin≥ 10g/L ALT and AST ≤2.5×ULN (≤5×ULN if liver metastasis)

Exclusion criteria

Exclusion Criteria:

  • Patients have not used drugs according to protocol
  • Patients were allergic to pemetrexed or cisplatin
  • Patients received radiotherapy or other biological treatment 4 weeks before the trial
  • Uncontrolled hydrothorax or hydropericardium
  • neuropathy toxicity ≥ CTC 3
  • Severe symptomatic heart disease
  • Active upper gastrointestinal ulcer or digestive disfunction
  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Interventions

  • DrugGefitinib

    250mg qd po d3-16

  • DrugPemetrexed

    500mg/m2 venous infusion,D1,q3w

  • DrugCisplatin or carboplatin

    Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w

06

What researchers measure

Primary outcomes

  1. response rate

    Time frame: six weeks

Secondary outcomes

  1. Number of Participants with Adverse Events

    according to NCI CTC V3.0

    Time frame: six weeks

  2. Progression free survival

    Time frame: six weeks

  3. quality of life

    according to FACT-LCS scores

    Time frame: six weeks

07

Study locations

1 of 1 sites recruiting
  • Cancer hospital Fudan University
    Shanghai, Shanghai 200032, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01192243
Lead sponsor
Fudan University
First posted
Sep 1, 2010
Start date
Dec 2009
Primary completion
Dec 2011 (estimated)
Last update
Sep 3, 2010

Study contacts

Jianhua chang, MD,PHD
Contact
changjianhua@hotmail.com
13916619284
Jianhua Chang, MD,PhD
principal investigator · Fudan University affiliated cancer hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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