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

Last updated: February 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06491862
D133HR00041
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 250
Study Start date:
July 25, 2024
Estimated Completion Date:
June 30, 2025

Study 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%.

Connect with a study center

  • Research Site

    Natal, Rio Grande Do Norte 59062-000
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 01323-020
    Brazil

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.