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

Phase 2 Study of Gefitinib Compared With Pemetrexed/Cisplatin in Advanced Non-Small

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01192243

Enrollment

Registered

2010-09-01

Start date

2009-12-31

Completion date

Unknown

Last updated

2010-09-03

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

Conditions

Toxicity, Non-small Cell Lung Cancer

Keywords

Objective response rate, Time to Progression, Quality of Live

Brief 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).

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame
response rate	six weeks

Secondary

Measure	Time frame	Description
Number of Participants with Adverse Events	six weeks	according to NCI CTC V3.0
Progression free survival	six weeks	—
quality of life	six weeks	according to FACT-LCS scores

Countries

China

Contacts

Primary ContactJianhua chang, MD,PHD

changjianhua@hotmail.com13916619284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026