Maintenance Gemcitabine in the Chinese Advanced Lung Cancer

Summary

Lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. Approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (NSCLC) present with advanced stage that palliative chemotherapy is the only appropriate measure. The standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (PD) before the administration of second-line and third-line systemic anticancer therapeutic agents. Patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis.

Switch maintenance therapy with pemetrexed or erlotinib in patients with advanced NSCLC without PD after first-line chemotherapy has been confirmed to improve progression free survival (PFS) and overall survival (OS) significantly compared with placebo in two large randomized controlled studies. However, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of PFS without OS improvement. Thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic NSCLC with ECOG performance status of 0-1 and without PD after four cycles of first-line chemotherapy with gemcitabine and cisplatin in China.

Conditions

• Non Small Cell Lung Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine 1250mg/m\^2 Day 1 and 8, 28 days per cycle until PD

DRUG

Best supportive care

Best supportive care

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Tongji University

  lead OTHER

Principal Investigators

• Di Zheng, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Wen Gao, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Jianfang Xu, MD · Shanghai Pulmonary Hosptial

• Li Wang, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Meijun Lv, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Jian Ni, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Jie Zhang, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Bing Lu, MD · Shanghai Pulmonary Hospital, Shanghai, China

• Ying Xu, MD · Shanghai Pulmonary Hospital, Shanghai, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2012-04-30

Completion

2013-04-30

Countries

• China

Study Locations