Lung Cancer Clinical Trial
Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO
Summary
To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).
Eligibility Criteria
Inclusion Criteria:
Advanced Non-Small Cell Lung Cancer (NSCLC).
For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Estimated creatinine clearance ≥15 mL/min.
Exclusion Criteria:
Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
Patients with known diffuse interstitial lung disease (all cohorts).
Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)
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There are 67 Locations for this study
Duarte California, 91010, United States
Fullerton California, 92835, United States
Irvine California, 92604, United States
La Jolla California, 92037, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Pasadena California, 91105, United States
San Diego California, 92103, United States
San Luis Obispo California, 93401, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93150, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Santa Monica California, 90404, United States
Solvang California, 93463, United States
South Pasadena California, 91030, United States
Valencia California, 91355, United States
Westlake Village California, 91361, United States
Denver Colorado, 80205, United States
Grand Junction Colorado, 81501, United States
Lafayette Colorado, 80026, United States
Lonetree Colorado, 80124, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Lake City Florida, 32024, United States
Pembroke Pines Florida, 33028, United States
Athens Georgia, 30607, United States
Savannah Georgia, 31404, United States
Savannah Georgia, 31405, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Chicago Illinois, 60637, United States
Peoria Illinois, 61615, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Brownstown Michigan, 48183, United States
Dearborn Michigan, 48126, United States
Detroit Michigan, 48202, United States
Novi Michigan, 48377, United States
West Bloomfield Michigan, 48322, United States
Corinth Mississippi, 38834, United States
Southaven Mississippi, 38671, United States
Branson Missouri, 65616, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89169, United States
Livingston New Jersey, 07039, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
New York New York, 10003, United States
New York New York, 10011, United States
New York New York, 10032, United States
Stony Brook New York, 11794, United States
Hickory North Carolina, 28602, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Charleston South Carolina, 29414, United States
Memphis Tennessee, 38104, United States
Memphis Tennessee, 38120, United States
Fort Worth Texas, 76177, United States
Fort Worth Texas, 76177, United States
Burlington Vermont, 05401, United States
Burlington Vermont, 05405, United States
Fairfax Virginia, 22031, United States
Issaquah Washington, 98029, United States
Seattle Washington, 98104, United States
Seattle Washington, 98122, United States
Seoul , 110-7, Korea, Republic of
Seoul , 120-7, Korea, Republic of
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