Status:
COMPLETED
Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations
Lead Sponsor:
Pfizer
Conditions:
Metastatic Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a Phase 4, open label, single arm, multi-center, prospective clinical trial of dacomitinib that will be performed in India. This study will enroll a sufficient number of participants to ensure...
Detailed Description
This is a Phase 4, open label, single arm, multi-center, prospective clinical trial of dacomitinib that will be performed in India. This study will enroll a sufficient number of participants to ensure...
Eligibility Criteria
Inclusion
- Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test.
- No prior treatment with systemic therapy and EGFR/Other Tyrosine Kinase Inhibitors (TKIs) for metastatic NSCLC.
- Participants with asymptomatic Central Nervous System (CNS) metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible.
- Age \>=18 years.
- ECOG PS of 0-2.
- Adequate . hematologic, renal, liver function: ANC \>= 1000/mm3; Platelets\>=50000/mm3; Hb \>=8 g/dL; est. Cr.Cl \>=30 mL/min; Total serum bilirubin \<1.5 × ULN; AST,ALT \<=2.5 × ULN; (\<=5.0 × ULN, if liver metastases).
- Acute effects of any prior therapy resolved to baseline severity or to Common Terminology Criteria for Adverse Events (CTCAE) Grade \<1 except for AEs that in the investigator's judgment do not constitute a safety risk for the participant.
- Serum or urine pregnancy test (for females of childbearing potential) negative at Screening.
Exclusion
- Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
- Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
- Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Prior irradiation to \>25% of the bone marrow.
- 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.
- Known prior or suspected severe hypersensitivity to dacomitinib or any component of its formulation.
- History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
- 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.
- Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of dacomitinib.
- Breastfeeding female participants.
- Pregnant female participants; male participants able to father children and female participants of childbearing potential who are unwilling or unable to use contraception method per protocol
Key Trial Info
Start Date :
August 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04511533
Start Date
August 27 2020
End Date
November 8 2022
Last Update
April 5 2024
Active Locations (15)
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1
The Gujarat Cancer and Research Institute
Ahmedabad, Gujarat, India, 380016
2
Hemato Oncology Clinic Ahmedabad Pvt. Ltd
Ahmedabad, Gujarat, India, 380054
3
Gujarat Hospital - Gastro & Vascular Centre
Surat, Gujarat, India, 395009
4
Unity Trauma Center And ICU (Unity Hospital )
Surat, Gujarat, India, 395009