- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02282267
Blood Detection of EGFR Mutation For Iressa Treatment (Benefit)
February 22, 2017 updated by: Jie Wang, Peking University Cancer Hospital & Institute
This study was proposed to validate the efficacy of gefitinib as first-line therapy in advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA.
Study Overview
Detailed Description
Patients without enough tissue for EGFR mutation detection can also have opportunity to use EGFR-TKI as first line therapy.
Meanwhile, this study was also proposed to explore the best intervention time of anti-resistant drugs (such as AZD 9291, a T790M inhibitor) through the quantitative and dynamic analysis of EGFR sensitive and resistant mutation in plasma cf-DNA during EGFR-TKI treatment process.
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Beijing Cancer Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Male or female patients aged ranging from 18 to 75 years old.
- Histological confirmation of lung adenocarcinoma. Attention: the paraffin embedded cytological samples extracted from pleural effusion are acceptable. Adeno-squamous carcinoma is not allowed to enroll. Sputum cytology alone cannot be acceptable. Bronchoalveolar lavage and fine needle aspiration cytology specimens for lesions also cannot acceptable.
- Metastatic lung adenocarcinoma (stage Ⅳ, IASLC, 2009).
- EGFR sensitive mutation (including exon 19 del and/or exon 21 L858R) in plasma cf-DNA by ddPCR.
- Chemotherapy, immunotherapy and other systemic anti-cancer treatment (such as EGFR inhibitor including other EGFR tyrosine kinase inhibitor and EGFR antibody, and anti-vascular therapy including vascular epithelial growth factor receptor inhibitor and Endostar) naïve. Radical surgery and radiotherapy must be completed at least 6 months before start of study treatment. Adjuvant chemotherapy is allowed and must be finished at least 6months before start of study drug. Palliative radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity.
- At least one lesion, not previously irradiated, that can be accurately measured at baseline as 10mm in the longest diameter (lymph nodes must have short axis more than 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
- WHO Performance Status 0, 1 or 2.
- Criteria for laboratory examinations:
Blood white cell count≥3.0*109/L, Neutrophile cell count ≥1.5*109/L Platelet count ≥100*109/L Total bilirubin (TB) ≤ 1.5 times upper limit of normal Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2 times upper limit of normal; for subjects with hepatic metastasis, AST, ALT≤ 5 times upper limit of normal Creatinine clearance≥50ml/min
Exclusion Criteria:
- Known severe allergic to gefitinib or any excipient of the product.
- Considered to require radiotherapy to the lung at the time of study entry or in the near future.
- Newly diagnosed symptomatic central nervous system (CNS) metastasis or spinal cord compression unless treated with surgery and/or radiation and stable without steroid for at least 2 weeks.
- Uncontrolled massive pleural or pericardial effusion.
- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
- The presence of idiopathic pulmonary fibrosis in baseline CT scans.
- Combined use of phenytoin, rifampin, carbamazepine, pentobarbital or St. John's wort.
- Any obvious ocular anomalies, especially severe dry eye syndrome, keratoconjunctivitis sicca, serious exposure keratitis or other potentially increased epithelial lesions.
- As judged by the investigator, any evidence of severe of uncontrolled systemic disease (e.g. active infection, uncontrolled hypertension unstable angina, congestive hear failure, liver, kidney or metabolic diseases).
- Could not accept oral administration, need intravenous nutrition, previous operation that affect absorption or active peptic ulcer.
- Pregnant or lactating women.
- Prior administration of other study drug or drug without approval within 30 days before the first day of study drug administration.
- Other co-existing malignancies on malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intra-mucosal gastric cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Gefitinib
Patients with EGFR mutation in plasma detected by droplet digital PCR could receive Gefitinib 250mg every day until disease progression.
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Iressa 250mg oral daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate of gefitinib
Time Frame: up to 6 months
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up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: jie wang, doctor, Peking University Cancer Hospital & Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
October 31, 2014
First Submitted That Met QC Criteria
October 31, 2014
First Posted (Estimate)
November 4, 2014
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenocarcinoma of Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Gefitinib
Other Study ID Numbers
- BJCHDTC002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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