A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)

Metastatic Non-small Cell Lung Cancer Clinical Trial

Official title:

An Observational Study Describing Diagnosis and Treatment Patterns in Adults With Metastatic Non-small Cell Lung Cancer With BRAF V600E Mutation in Clinical Practice, to Assess Treatment Effectiveness and Quality of Life (OCTOPUS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546905
• Other study ID #: NIS12500
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Pierre Fabre Medicament
• Contact: Farida Beghdad
• Phone: +33788394738
• Email: farida.beghdad[@]pierre-fabre.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation. This study will also describe Real-World Progression-Free Survival (rwPFS) and Overall Survival (OS) for treatments prescribed in routine practice for mNSCLC with BRAF V600E mutation. Adverse events (AEs) related to treatment management will also be described.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years at the time of first-line treatment initiation for mNSCLC,
• Patients who initiated a first systemic treatment for mNSCLC in the metastatic setting from 01 December 2017 and before their study entry date (retrospectively enrolled patients), or Patients who initiated a first systemic treatment for mNSCLC (metastatic setting) at or after their study entry date (prospectively enrolled patients),
• Confirmed diagnosis of Stage IV mNSCLCat any time before study inclusion Stage IV M1a, M1borM1c, as per the American Joint Committee on Cancer (AJCC cancer) staging manual,
• Confirmed presence of BRAF V600E mutation - via tumor biopsy, metastasectomy, or liquid biopsy - at anytime before study inclusion,
• Signed ICF or non-opposition to study participation,according to local regulations. Patients eligible for prospective QoL data collection must, in addition to the above

mentioned criteria, meet ALL of the following criteria to be eligible for the study:

• Patients who initiate a first or second systemic treatment line for mNSCLC (metastatic setting) with a BRAF V600E mutation at or after their study entry date

Exclusion Criteria:

• Concurrent or another previous malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, in-situcarcinoma of the cervix, Bowen's disease or Gleason = 6 prostate cancer,
• Previous, ongoing, or planned participation in a clinical trial involving an interventional drug as a first-or second-line systemic treatment for mNSCLC.

Related Conditions & MeSH terms

• BRAF V600 Mutation
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer

Locations

Country	Name	City	State
France	CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel	Lyon	Rhône Alpes

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Medicament	Iqvia Pty Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC	Names of regimens/agents	From the start of first or second line treatment to progression or date of death from any cause,assessed up to 30 months
Primary	Description of line of treatment	Line of treatment number overall, not limited to metastatic setting	From the start of first or second line treatment to the end of second line treatment,assessed up to 30 months
Primary	Description of duration of treatment line	Duration of treatment line = End date of treatment line - Start date of treatment line	From the start of first or second line treatment to the end of line treatment,assessed up to 30 months
Primary	Time to treatment discontinuation	Time to treatment discontinuation defined as the time between the date of start of a medication and the date of treatment discontinuation or death.	From the start of first or second line treatment to the treatment discontinuation or death,assessed up to 30 months
Primary	Time to next treatment	Time to next treatment defined as the time between the date of start of a medication and the date of start of the next LoT.	From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months