Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Dacomitinib (PF-00299804): 45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or
unacceptable toxic
Sponsors
Pfizer Inc
Pfizer Products India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: (1)Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test. (2)No prior treatment with systemic therapy and EGFR/Other TKIs for metastatic NSCLC. (3)Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. (4)Age �18 years. (5)ECOG PS of 0-2. (6)Adequate. hematologic, renal, liver function. (7)Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade (8)Serum or urine pregnancy test (for females of childbearing potential) negative at Screening. Contraceptive use should be consistent with the approved India local product document for Dacomitinib.
Exclusion criteria
Exclusion criteria: (1)Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer (2)Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation (3)Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation ( 25% of the bone marrow. (4)Major surgery within 4 weeks prior to first dose of Dacomitinib. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing. (5)Known prior or suspected severe hypersensitivity to Dacomitinib or any component of its formulation (6)History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis. (7)Other severe acute or chronic medical or psychiatric condition, that may interfere with the interpretation of study results and, would make the participant inappropriate for entry into this study. (8)Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of Dacomitinib. (9)Breastfeeding female participants (10)Participation in other studies involving investigational drug(s) (Phases 1 - 4) within 2 weeks before the current study begins and/or during study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs)Timepoint: From the time of first dose to 28 days post last dosing date or the date of initiation of a new anticancer therapy, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Confirmed ORR and DoR as assessed by the investigator using RECIST version 1.1.Timepoint: From time of first dose (for ORR) or time of first tumor response (for DoR) until disease progression, death or initiation of a new anticancer therapy, whichever occurs first. | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer Products India Private Limited
Outcome results
None listed