A Study to Learn About Dacomitnib in Patients With Non-small Cell Lung Cancer Which Has Spread to the Brain.

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06075615
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 35.3

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer which has spread to other parts of the body.

This study is seeking participants who:

• have lung cancer that has reached at least the brain.

• have a type of gene called epidermoid growth factor receptor. A gene is a part of your DNA that has instructions for making things your body needs to work.

• have not received any treatment before.

All participants in this study will receive dacomitnib 1 time a day. Dacomitinib is a tablet that is taken by mouth at home. They can continue to take dacomitnib until their cancer is no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: dacomitnib

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Multicenter, Observational Study to Describe the Effectiveness and Treatment Patterns of Dacomitinib Among Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer Patients With Brain Metastasis
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Sep 7, 2026
• Anticipated Study Completion Date: Sep 7, 2026

Arms and Interventions

Arm	Intervention/Treatment
dacomitnib	Drug: dacomitnib; patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis

Outcome Measures

Primary Outcome Measures

1. The real-world intracranial overall response rate (rwICORR) at Month 3 [3 months from first dose of dcomitnib]

   The percentage of patients achieving real-world intracranial overall response (complete response (CR) or partial response (PR)) for brain metastases at Month 3 (± 4 weeks) will be summarized.

2. The real-world intracranial overall response rate (rwICORR) at Month 6 [6 months from first dose of dacomitnib]

   The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.

3. The real-world intracranial overall response rate (rwICORR) at Month 12 [12 months from first dose of dacomitinib]

   The percentage of patients achieving real-world intracranial overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.

4. The real-world intracranial clinical benefit rate (rwICBR) at Month 3 [3 months from first dose of dacomitinib]

   The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 3 (± 4 weeks) will be summarized

5. The real-world intracranial clinical benefit rate (rwICBR) at Month 6 [6 months from first dose of dacomitinib]

   The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 6 (± 4 weeks) will be summarized

6. The real-world intracranial clinical benefit rate (rwICBR) at Month 12 [12 months from first dose of dacomitinib]

   The percentage of patients with real-world intracranial clinical benefit (CR, PR or SD) for brain metastases at Month 12 (± 4 weeks) will be summarized

7. The real-world intracranial time to progression (rwICTTP) [30 months from first dose of dacomitinib]

   The mean and median of the time to the date of the first documentation of real-world progression of intracranial disease.

8. The real-world systemic overall response rate (rwORR) at Month 3 [3 months from first dose of dacomitinib]

   The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 3 (± 4 weeks) will be summarized.

9. The real-world systemic overall response rate (rwORR) at Month 6. [6 months from first dose of dacomitinib]

   The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 6 (± 4 weeks) will be summarized.

10. The real-world systemic overall response rate (rwORR) at Month 12. [12 months from first dose of dacomitinib]

    The number and percentage of patients achieving real-world systemic overall response (CR or PR) for brain metastases at Month 12 (± 4 weeks) will be summarized.

11. The real-world progression-free survival (rwPFS) during 12 months from index date [12 months from index date]

    Time to real-world disease progression or death, whichever occurs first, during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.

12. The real-world overall survival (rwOS) during 12 months from index date [12 months from index date]

    Time to real-world death during 12 months from index date will be summarized by the K-M plot with the corresponding 95% CI.

13. The real-world overall survival (rwOS) during 24 months from index date [24 months from index date]

    Time to real-world death during 24 months from index date will be summarized by the K-M plot with the corresponding 95% CI.

Secondary Outcome Measures

1. Percentage of patients with dacomitinib treatment discontinuation [30 months from first dose of dacomitinib]

   The percentage of patients with dacomitinib treatment discontinuation for any reason during follow-up period will be summarized.

2. Time to dacomitinib treatment discontinuation [30 months from first dose of dacomitinib]

   Time to dacomitinib treatment discontinuation during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.

3. Number of patients with dacomitinib dosage change and reasons [30 months from first dose of dacomitinib]

   The number of patients with dacomitinib dosage change and reason during follow-up period will be summarized.

4. Time to dacomitinib dosage change [30 months from first dose of dacomitinib]

   Time to dacomitinib dosage change during follow-up period will be summarized by the K-M plot with the corresponding 95% CI.

5. Concomitant NSCLC-related treatment [30 months from first dose of dacomitinib]

   The number patients with concomitant NSCLC-related treatment will be summarized.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• at least 18 years old

• confirmed diagnosis of EGFR mutation-positive NSCLC

• at least one measurable intracranial metastasis

• ECOG-PS of 0, 1 or 2

• dacomitinib as first-line treatment for advanced NSCLC

• Evidence of a personally signed and dated informed consent document (ICD)

Exclusion Criteria:

• any anti-cancer systemic treatment within 12 months prior to index date

• currently on active investigational drug(s) treatment in other clinical studies (Phase 1-4) within 2 weeks before the current study begins and/or during study participation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT06075615
• Other Study ID Numbers: A7471072
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Oct 10, 2023