Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT02770014
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Epidermal Growth Factor Receptor
- Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUG
Study Details
Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study. This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy.
Key Dates
- First listed
- May 12, 2016
- Start date
- Jun 30, 2016
- Status verified
- Nov 2019
- Primary completion
- Apr 16, 2019
- Completion
- Jun 19, 2019
Study Design
- Enrollment
- 43 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: EGFR mutation Positive, Treatment With ErlotinibEligible EGFR mutations include exon 19 deletion or exon 21 L858R mutation. Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
Primary Outcome Measure
Overall Response Rate [ Time Frame: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation. ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | - |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
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