Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib

NCT05988697 | Not Yet Recruiting DMC

• 1 other identifier: DATE
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to observe the safety and efficacy of Aspirin combined with Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung cancer (NSCLC)

Conditions

NSCLC; BRAF V600E Mutation; Advanced Cancer; Stage IIIB NSCLC; Stage IV NSCLC

Keywords

NSCLC; Asprin; Dabrafenib; Trametinib; PFS; BRAF V600E mutation

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression-free survival (PFS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib

  3 years

• Proportion of patients with fever

  Refers to the proportion of patients with fever from the beginning of treatment to the end of follow-up.

  C

Secondary Outcomes (4)

• OS

  3 years

• ORR

  3 years

• DCR

  3 years

• Risk of coronary events

  3 years

Other Outcomes (2)

• Effectiveness evaluation/efficacy analysis

  3 years

• Security assessment

  3 years

Study Arms (1)

Observation group

Primary IIIB-IV BRAF V600E mutated advanced non-small cell lung cancer in a population of patients with advanced lung cancer proposed to be treated with Trametinib， Dabrafenib and Asprin

Drug: Combind asprin with Trametinib and Dabrafenib

Interventions

Combind asprin with Trametinib and Dabrafenib DRUG

Treatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1 tablet/time, QD

Observation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is aimed at patients with advanced non-small cell lung cancer with BRAF V600E mutation in primary stage IIIB-IV. Dabrafenib and Trametinib are proposed for the treatment of advanced lung cancer

You may qualify if:

• Inoperable stage IIIB-IV patients with non-small cell lung cancer;
• BRAF V600E mutation;
• Dabrafenib and Trametinib are planned for treatment, and the survival period is expected to be more than 3 months;
• ECOG PS 0/1;
• The diameter of the primary lesion should be at least 1cm;
• Previous or current aspirin treatment was allowed

You may not qualify if:

• The patient is currently receiving other anticoagulant therapy;
• The patient was previously treated with systemic anti-NSCLC;
• The patient had other positive driver mutations, including EGFR, ALK, ROS1, MET14, RET, etc.
• The patient had contraindications for dalafenib or trametinib and aspirin use;
• Patients who refused follow-up visits;

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

trametinib; dabrafenib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

He Yong, MD

CONTACT

86-23-68757791; heyong@dphospital.tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Respiratory Diseases

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 12, 2023

Record last verified: 2023-10