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
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Dacomitinib; Dacomitinib; Doxycycline; Probiotic; Alclometasone cream
Intervention description: Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent; Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent; Doxycycline or Doxycycline placebo BID for 4 weeks; VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28); Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks
Intervention MeSH terms: Doxycycline; Alclometasone dipropionate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-small cell lung cancer; advanced; previously treated

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)