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

NCT06075615 | Withdrawn

• 2 other identifiers: A7471072NCT06075615
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Dacomitinib, Non-Small Cell Lung Cancer, Brain Metastasis

Outcome Measures

Primary Outcomes (13)

• The real-world intracranial overall response rate (rwICORR) at Month 3

  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.

  3 months from first dose of dcomitnib

• The real-world intracranial overall response rate (rwICORR) at Month 6

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

  6 months from first dose of dacomitnib

• The real-world intracranial overall response rate (rwICORR) at Month 12

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

  12 months from first dose of dacomitinib

• The real-world intracranial clinical benefit rate (rwICBR) at Month 3

  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

  3 months from first dose of dacomitinib

• The real-world intracranial clinical benefit rate (rwICBR) at Month 6

  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 months from first dose of dacomitinib

• The real-world intracranial clinical benefit rate (rwICBR) at Month 12

  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

  12 months from first dose of dacomitinib

• The real-world intracranial time to progression (rwICTTP)

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

  30 months from first dose of dacomitinib

• The real-world systemic overall response rate (rwORR) at Month 3

  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.

  3 months from first dose of dacomitinib

• The real-world systemic overall response rate (rwORR) at Month 6.

  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.

  6 months from first dose of dacomitinib

• The real-world systemic overall response rate (rwORR) at Month 12.

  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.

  12 months from first dose of dacomitinib

• The real-world progression-free survival (rwPFS) during 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 months from index date

• The real-world overall survival (rwOS) during 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.

  12 months from index date

• The real-world overall survival (rwOS) during 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.

  24 months from index date

Secondary Outcomes (5)

• Percentage of patients with dacomitinib treatment discontinuation

  30 months from first dose of dacomitinib

• Time to dacomitinib treatment discontinuation

  30 months from first dose of dacomitinib

• Number of patients with dacomitinib dosage change and reasons

  30 months from first dose of dacomitinib

• Time to dacomitinib dosage change

  30 months from first dose of dacomitinib

• Concomitant NSCLC-related treatment

  30 months from first dose of dacomitinib

Study Arms (1)

dacomitnib

Drug: dacomitnib

Interventions

dacomitnib DRUG

patients with dacomitnib as first line treatment for advanced NSCLC with brain metastasis

dacomitnib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with epidermoid growth factor receport (EGFR)-positive non-small cell lung cancer (NSCLC) with brain metastasis

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 10, 2023
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 7, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share