Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Dacomitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.

Daniel Tan, BSc, MBBS, PhD

This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC).

National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.

Phase 2 Study of Dacomitinib in NSCLC

A Single-arm, Open-label, Phase 2 Study of Dacomitinib With or Without Dose Titration for the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Subjects With an Epidermal Growth Factor Receptor (EGFR) Activation Mutation

Percentage of subjects with PFS at 12 months

Proportion of subjects with a best overall response of either complete response (CR) or partial response (PR)

Proportion of subjects with a best overall response of either CR or PR of intracranial disease

Pfizer

National Cancer Centre, Singapore

This group is included the patients that Vizimpro are prescribed and administrated according to local label in the routine clinical practice

Vizimpro

Pfizer CT.gov Call Center

Vizimpro will be approved for the treatment of EGFR NSLCL 1L in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Vizimpro after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Vizimpro will be observed.

Korea Post Marketing Surveillance (PMS) Study of Vizimpro

A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Vizimpro®

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This study is observation, non-intervention study in routine clinical practice. Response rate according to RECIST criteria will be collected under routine clinical practice visit.

Neoplasm Metastasis

Patients with EGFR mutation-positive inoperable or recorrent NSCLN (non-small cell lung cancer) who have not received VIZIMPRO (dacomitinib hydrate)

The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.

dacomitinib hydrate

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

Special Investigation for Vizimpro Tablets

The number and proportion of patients with ILD (interstitial lung disease) will be tabulated by subgroup by risk factor

Response rate will be calculated. The response rate is defined as the propotion of patients with a best ovarall response of CR ro PR in the effectiveness analysis set.

The number and population of patients with adverse reactions will be tabulated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of Dacomitinib in NSCLC	NCT04027647	NSCLC Stage III... NSCLC Stage III... NSCLC Stage IV Recurrent NSCLC EGFR Positive N...	Dacomitinib	18 Years -	National Cancer Centre, Singapore
Korea Post Marketing Surveillance (PMS) Study of Vizimpro	NCT04721106	Lung Neoplasms	Vizimpro	19 Years -	Pfizer
Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)	NCT04155541	EGFR Mutation-p...	dacomitinib hyd...	0 Years -	Pfizer
Korea Post Marketing Surveillance (PMS) Study of Vizimpro	NCT04721106	Lung Neoplasms	Vizimpro	19 Years -	Pfizer

Spots Global Cancer Trial Database for vizimpro

Every month we try and update this database with for vizimpro cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vizimpro

Every month we try and update this database with for vizimpro cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vizimpro cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.