Status:
TERMINATED
Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC
Lead Sponsor:
Sichuan University
Collaborating Sponsors:
AstraZeneca
Conditions:
Non-small Cell Lung Cancer Metastatic
EGFR Activating Mutation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Study Title: Intercalating and maintenance Gefitinib in combination with chemotherapy (gemcitabine plus carboplatin) as first-line treatment for patients with advanced EGFR mutation-positive non-smal...
Detailed Description
Study Design: It is a two-arm, prospective, randomized, open-label, multi-center study. The study will be conducted at 5 study sites in China. West China Hospital serves as the lead site for the stud...
Eligibility Criteria
Inclusion
- Subjects enrolled in this study are required to meet the following inclusion criteria:
- Patients between 18 and 75 years of age.
- Patients with histologically or cytologically diagnosed NSCLC,or patients with recurrent advanced NSCLC after surgery.
- Harboring activating mutation of EGFR,only including an exon 19 deletion or an exon 21 point mutation.
- Has at least one measureable lesion by RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior systemic chemotherapy or targeted therapy for lung cancer before screening except neoadjuvant or adjuvant patients.
- Adequate organ function, including the following:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.5 × 109/L,platelets ≥100 × 109/L,and hemoglobin ≥9 g/dL.
- Hepatic: bilirubin ≤1.5 times the upper limit of normal (× ULN),alkaline phosphatase (AP),aspartate transaminase (AST),and alanine transaminase (ALT) ≤3.0 × ULN (AP,AST and ALT ≤5 × ULN is acceptable if the liver has tumor involvement).
- Renal: calculated creatinine clearance (CrCl) ≥45 mL/minute based on the standard Cockcroft and Gault formula.
- 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 enrolment.
- Signed informed consent document on file.
- Estimated life expectancy of ≥12 weeks.
- Patient compliance and geographic proximity that allow adequate follow up.
Exclusion
- Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
- Known severe hypersensitivity to gefitinib.
- Known brain metastasis unless asymptomatic brain metastasis(without neurotic symptoms and sign) and treated with surgery and/or radiation and stable without steroid treatment for at least 2 weeks prior to the first dose of study medication.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
- Previous treatment with agents targeting the HER axis.
- Previous systemic antitumour treatment.
- The last regimen of neoadjuvant or adjuvant treatment for non-metastatic disease within 12 months of study treatment.
- EGFR Resistance mutation (+).
- Surgery undertaken less than 4 weeks before the study.
- 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 enrolment.
- Past medical history of Interstitial Lung Disease(ILD),drug induced interstitial disease,radiation pneumonitis which required steroid treatment,or any evidence of clinically active ILD.
- Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
- Unwillingness to use contraception during the study, women who were pregnant or lactating.
- Being or planing to participate in other studies.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02299765
Start Date
December 1 2014
End Date
October 1 2017
Last Update
November 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
China West Hospital
Chengdu, Sichuan, China, 610000