RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non-squamous Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous Non-Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy in Brazil
Overview
The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with a/m non-squamous NSCLC with or without AGA and received at least 1 line of systemic treatment after failing PTC between January 2017 and December 2024.
Detailed description
The study will be implemented as a retrospective, noninterventional medical record review of patients from routine practice settings who have been diagnosed with advanced/metastaic non-squamous NSCLC with or without AGA and who have failed platinum-based chemotherapy and immunotherapy (for patients without AGA) or platinum-based chemotherapy and at least 1 line of targeted therapy (for patients with AGA). The study will be conducted on one cohort of patients regardless their AGA status. The study index date will be defined as first dose of any agent after PTC, with specific treatments received for AGA and non-AGA patients in the preindex period. We will also conduct a subgroup analysis on NSCLC pre-defined subtypes (sample size permitting): EGFR mutant, ALK translocation, ROS1 translocation, MET1 mutant, HER-2 mutant, BRAF mutant, pan-wild-type PD-L1 \>50%.
Primary outcome measures
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 21th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 21th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
- Describe the patient population and treatment patterns [Time frame: between January 1st 2017 and December 31th 2024]
Eligibility criteria
Inclusion criteria
- Confirmed diagnosis of patients with non-squamous NSCLC stage IIIB/IIIC not eligible for curative-intent therapies or stage IV/M1 (a/m NSCLC) with or without actionable genomic mutations (i.e., EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, RET, HER-2)
- Aged at least 18 years at first diagnosis of a/m NSCLC
- For the AGA subgroup, having received platinum-based chemotherapy, having received at least one target approved therapy.
- For the non\_AGA subgroup,should have received either sequential or concurrent use of ICI and PTC)
- Patient must have received at least line of therapy of an active agent after failing PTC.
Exclusion criteria
- Patients with evidence of other primary malignancies (apart from basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both the study cohorts.
- Patients who participated in an investigational clinical trial for the treatment of any cancer, including NSCLC, or any early access program from 2018 onward.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 11 centers
- Research Site — Belo Horizonte
- Research Site — Belo Horizonte
- Research Site — Natal
- Research Site — Porto Alegre
- Research Site — São José do Rio Preto
- Research Site — São Paulo
- Research Site — São Paulo
- Research Site — São Paulo
- … and 3 more centers
Identifiers
NCT: NCT06491862 · D133HR00041