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Recruiting Phase 2 NCT03586453

Osimertinib In EGFR Mutant Lung Cancer

Trial Parameters

Condition Carcinoma, Non-Small-Cell Lung
Sponsor Dana-Farber Cancer Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-08-13
Completion 2026-02-28
Interventions
Osimertinib

Brief Summary

This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The names of the study drug involved in this study is: \- Osimertinib (Tagrisso)

Eligibility Criteria

Inclusion Criteria: * Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory from tumor tissue. --Note: recurrent stage IV disease initially diagnosed at an earlier stage is considered eligible, provided prior treatment criteria is met. * Participants must have measurable disease at baseline, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. * Participants must be aged ≥ 18 years * Participants must have an ECOG performance status of 0-1 (Appendix A) * Participants must have normal organ and marrow function as defined below: * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * hemoglobin \>9.0 g/dL * t

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