Vinorelbine-ifosfamide Versus Gefitinib for EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In the National Comprehensive Cancer Network (NCCN) guideline for NSCLC, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) is recommended as the third-line treatment for EGFR gene mutation negative NSCLC patients who failed to the first-line platinum doublet chemotherapy [i.e. paclitaxel-carboplatin (PC) or gemcitabine-cisplatin (GP)] and the second-line chemotherapy with docetaxel or pemetrexed. But as we know, if patients had no EGFR gene mutation, EGFR-TKI treatment is not effective. The overall survival is short and the objective response rate is low. As for EGFR gene wild type patients with good performance status, besides EGFR-TKI treatment, other first generation cytotoxic drugs i.e. vinorelbine or ifosfamide maybe an alternative treatment. So the purpose of this clinical trial is to compare the effectiveness and safety of vinorelbine-ifosfamide with gefitinib in advanced or metastatic EGFR gene mutation negative NSCLC patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Gefitinib; Ifosfamide; Isophosphamide mustard; Mesna; Vinblastine; Vinorelbine

Criteria

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 ifosfamide;

• 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;