CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 101 enrolled
Drug / intervention
Dacomitinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04511533
NCT04511533Phase 4Completed
CompareCT.gov

SINGLE ARM STUDY TO EVALUATE THE SAFETY OF DACOMITINIB FOR THE FIRST-LINE TREATMENT OF PARTICIPANTS IN INDIA WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR)-ACTIVATING MUTATIONS

Pfizer·interventional·Posted Aug 13, 2020·Updated Apr 5, 2024

In Brief

A Phase 4 clinical trial evaluating Dacomitinib for Metastatic Non Small Cell Lung Cancer. Completed, enrolled 101 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non Small Cell Lung Cancer
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 13, 2020
Enrollment StartAug 27, 2020
Primary CompletionOct 15, 2022
Study CompletionNov 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.9 years ago

Interventions

Dacomitinibdrug

Dacomitinib is a kinase inhibitor indicated for the first line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.