RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil

Recruiting

• Conditions: Non-squamous Non-Small Cell Lung Cancer

• Registration Number: NCT06491862
• Lead Sponsor: AstraZeneca

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%.

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-07-04
• Study First Posted: 2024-07-09
• Study Start: 2024-07-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the patient population and treatment patterns	between January 1st 2017 and December 31th 2022	Description of patient population and treatment patterns: reasons for discontinuation
Describe of the population and treatment patterns	between January 1st 2017 and December 31th 2022	Description of patient population and treatment patterns: duration of therapy

Trial Locations

Locations (1)

Research Site; 🇧🇷 Sao Paulo, Brazil