Phase 4
N=101
Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations
Metastatic Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04511533 ↗Enrolled (actual)
101
Serious AEs
15.8%
Results posted
Apr 2024
Primary outcome: Primary: Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs) — 94; 16; 92; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dacomitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-Causality and Treatment-Related Treatment-Emergent Adverse Events (TEAEs) |
94; 16; 92; 7 | — |
| SECONDARY Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment |
50.5 | — |
| SECONDARY Duration of Response (DOR) as Per RECIST Version 1.1 Based on Investigator Assessment |
11.1 | — |
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 that 100 participants are treated with dacomitinib. The primary objective of this study is to assess the safety and tolerability of dacomitinib. The secondary objective is to evaluate antitumor activity of dacomitinib by objective response rate and duration of response.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT04511533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.