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)

  • STATUS
    Recruiting
  • End date
    Dec 14, 2024
  • participants needed
    200
  • sponsor
    Pierre Fabre Medicament
Updated on 14 October 2022

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.

Details
Condition Metastatic Non-small Cell Lung Cancer, BRAF V600 Mutation
Clinical Study IdentifierNCT05546905
SponsorPierre Fabre Medicament
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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