Clinical trial NCT06491862: RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-squamous Non-Small Cell Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of sequential adult patients in study sites with a diagnosis of IIIB/IIIC/IV non-squamous NSCLC with or without AGA and received at least 1 line of treatment after failing PTC for a/m NSCLC with a start date between January 2017 and December 2022.

Brief summary: 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 2022.

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%.

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.

Primary outcomes:
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 21th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 21th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe of the population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
measure: Describe the patient population and treatment patterns
timeFrame: between January 1st 2017 and December 31th 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Research Site
state: Rio Grande Do Norte
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
Study officials:
References: