Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations

Phase 4

• Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

• Registration Number: CTRI/2020/07/026825
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 <1 except for AEs that in the investigators judgment do not constitute a safety risk for the participant.

(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

(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 ( <10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry. Prior irradiation to >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified