Non-small Cell Lung Cancer Clinical Trial
— ISCANOfficial title:
Intercalating and Maintenance Use of Iressa vs. Chemotherapy in Selected Advanced NSCLC: a Randomised Study
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 .
Status | Completed |
Enrollment | 220 |
Est. completion date | October 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - After two cycles chemotherapy(gemcitabine plus carboplatin), patients with stable disease(SD) by RECIST1.1. - Patients between 18 and 75 years of age. - Present with histologically proven or cytological diagnosis of adenocarcinoma NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy,such as surgery or radiotherapy and so on. - No prior systemic chemotherapy or targeted therapy for lung cancer before screening. - Never smokers(defined as having smoked less than 100 cigarettes in their lifetime ) or light ex-smokers (defined as having ceased smoking at least 15 years before Day 1 of study treatment and having smoked 10 pack-years or fewer). - EGFR mutation status unknown. - ECOG performance status of 0 or 1. - Adequate organ function. - Prior radiation therapy allowed to <25% of the bone marrow . Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. - Signed informed consent document on file. - Estimated life expectancy of =12 weeks. - Patient compliance and geographic proximity that allow adequate follow up. Exclusion Criteria: - Known severe hypersensitivity to gefitinib. - Sympotomatic patients with brain metastases. - Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures. - Inability to comply with protocol or study procedures. - A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. - A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. - Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. - Interstitial pneumonia. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Shanghai Lung Tumor Clinical Center,Shanghai Chest Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Guangdong Association of Clinical Trials | Changhai Hospital, First Hospital of Jilin University, First People's Hospital of Hangzhou, Fudan University, Henan Cancer Hospital, Jiangsu Cancer Institute & Hospital, NanJing PLA 81 Hospital, Nanjing PLA General Hospital, Ruijin Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Soochow University, Wuxi No. 4 People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RECIST1.1 | Patients were imaged with computed tomography (CT) scan. | eight weeks | Yes |
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