Know Cancer

forgot password

A Phase Ⅱ Randomized Clinical Trial Comparing Vinorelbine-ifosfamide With Gefitinib as Third-line Treatment in Advanced EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients

Phase 2
18 Years
70 Years
Open (Enrolling)
Non-small Cell Lung Cancer, Effects of Chemotherapy

Thank you

Trial Information

A Phase Ⅱ Randomized Clinical Trial Comparing Vinorelbine-ifosfamide With Gefitinib as Third-line Treatment in Advanced EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients

Ifosfamide is a first generation cytotoxic drug to treat NSCLC. Phase Ⅱ studies demonstrated
that single-agent ifosfamide administrated by various schedules produces response rates of
15-29%, with media survival times of 5-7 months. Ifosfamide has also been used in various
combination regimens to treat NSCLC, including platinum based and non-platinum regimens. But
in refractory NSCLC patients platinum and some third generation cytotoxic drugs have been
used before. So in this study, ifosfamide is combined with vinorelbine. In previous study,
Masters reported the objective response rate was 40% and the median survival duration was 50
weeks, with a 1-year survival rate of 48% with vinorelbine-ifosfamide regimen [Vinorelbine
15 mg/m2 on days 1-3, and ifosfamide 2.0g/m2 on days 1-3 with granulocyte-colony stimulating
factor (G-CSF) support]. The dose limiting toxicity (DLT) of this regimen is
myelosuppression. In our experience, the regimen of vinorelbine 25mg/m2 d1, d8 and
ifosfamide 1.25g/m2 d1-d3 with Mesna uroprotection is safe in Chinese population and the
objective response rate is about 7% (data not published).

Gefitinib is the first small molecule inhibitor that has directed activity towards EGFR and
has shown appreciable response rates in phase Ⅱ trials of patients with previously treated
advanced NSCLC. In the posterior analysis of Iressa Dose Evaluation in Advanced Lung Cancer
(IDEAL) and IRESSA Survival Evaluation in Lung Cancer (ISEL) trials, the response rate with
gefitinib ranges from 2.6% to 10% in wild-type EGFR gene NSCLC patients.

Inclusion Criteria:

- age range:18-70 years old

- life expectancy more than 12 weeks

- histologically or cytologically confirmed inoperable NSCLC (stage ⅢB/Ⅳ)

- ineligible for curative radiotherapy

- no prior radiotherapy for the target lesions

- Eastern Cooperative Oncology Group (ECOG) performance score of 0-2;

- prior treatments include first-line platinum doublet chemotherapy i.e. PC or GP and
second-line chemotherapy with docetaxel or pemetrexed;

- No EGFR gene mutation detected by Scorpions-ARMS;

- at least one bidimensionally measurable or radiographically assessable lesion;

- adequate bone marrow reserve;

- adequate hepatic and renal function;

Exclusion Criteria:

- prior treatments including any of the following drugs:gefitinib,vinorelbine and

- additional malignancies;

- uncontrolled systemic disease;

- any evidence of clinically active interstitial lung disease;

- newly diagnosed central nervous system (CNS) metastasis and not treated by
radiotherapy or surgery;

- pregnancy or breast feeding phase;

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Description:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Outcome Time Frame:

up to 52 weeks (about one year)

Safety Issue:


Principal Investigator

Mengzhao Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Respiratory Medicine, Peking Unoin Medical College Hospital


China: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

December 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Effects of Chemotherapy
  • non small cell lung cancer
  • chemotherapy
  • gefitinib
  • vinorelbine
  • ifosfamide
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms