Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer

Summary

Platinum-based combination chemotherapy, such as gemcitabine-carboplatin, is one of the standard first-line therapy for advanced non-small cell lung cancer (NSCLC).

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) have clinical efficacy, as compared with the best supportive care or standard chemotherapy, when given as second-line or third-line therapy for advanced NSCLC.

Treatment with EGFR-TKI is most effective in female, never-smoker, or patients with adenocarcinoma, and patients of Asian origin. In these populations, such treatment is associated with favorable objective response rates, progression-free survival, and overall survival. These populations also have a relatively high incidence of somatic mutations in the region of the EGFR gene that encodes the tyrosine kinase domain.

The recent study(IPASS) by Tony S. Mok showed gefitinib was superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . In the subgroup of 261 patients who were positive for the EGFR gene mutation, PFS was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel(HR= 0.48,P\<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, PFS was significantly longer among those who received carboplatin-paclitaxel(HR=2.85,P\<0.001). Gefitinib treatment was well tolerated, with lower in hematologic toxicity, and no treatment-related interstitial lung disease.In this study(IPASS), only patients with a mutation of the EGFR gene in the tumor could get benefit from gefitinib as first line treatment.

Tony S. Mok and his colleague also found that intercalating and maintenance administration of erlotinib(another EGFR-TKI)following gemcitabine/platinum chemotherapy as first line therapy led to a significant improvement in PFS .

Conditions

• Non-small Cell Lung Cancer

Interventions

DRUG

Gefitinib

Gefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression

DRUG

Gemcitabine +Carboplatin

Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles

Sponsors & Collaborators

• The First Hospital of Jilin University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• Nanjing PLA General Hospital

  collaborator OTHER

• Wuxi No. 4 People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Changhai Hospital

  collaborator OTHER

• NanJing PLA 81 Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Guangdong Association of Clinical Trials

  lead OTHER

Principal Investigators

• Shun Lu, MD. · Guangdong Province Clinical Trial Association

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2015-03-31

Completion

2015-10-31

Countries

• China

Study Locations