Clinical trial NCT05546905: A Study in Patients With BRAF V600E-mutant Metastatic Non-small Cell Lung Cancer (OCTOPUS)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Non-small Cell Lung Cancer
BRAF V600 Mutation
Keywords: Metastatic Non-small Cell Lung Cancer
BRAF V600 Mutation
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2022-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients diagnosed with mNSCLC with a BRAF V600E mutation who initiated a first systemic treatment in the metastatic setting from December 01, 2017 to study entry date (retrospectively enrolled patients), as well as patients with BRAFV600E-mutant mNSCLC who initiated a first metastatic treatment upon inclusion (prospectively enrolled patients). Retrospectively enrolled patients can also be eligible for second-line prospective QoL data collection and contribute to a sub-cohort of prospective patients initiating their second line of treatment (LoT) after study entry. The study aims to enroll approximately 200 patients, of whom 50 patients are planned to complete full prospective follow-up for their first-line and/or second-line systemic treatment given in the metastatic setting in mNSCLC allowing for prospective QoL data collection in these patients.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Description of treatment regiment/agents for first and second systemic treatment lines for mNSCLC
timeFrame: From the start of first or second line treatment to progression or date of death from any cause,assessed up to 30 months
measure: Description of line of treatment
timeFrame: From the start of first or second line treatment to the end of second line treatment,assessed up to 30 months
measure: Description of duration of treatment line
timeFrame: From the start of first or second line treatment to the end of line treatment,assessed up to 30 months
measure: Time to treatment discontinuation
timeFrame: From the start of first or second line treatment to the treatment discontinuation or death,assessed up to 30 months
measure: Time to next treatment
timeFrame: From the start of first or second line treatment to the subsequent line treatment,assessed up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel
state: Rhône Alpes
Study officials:
References: