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NCT Number: NCT06491862

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Belo Horizonte, Minas Gerais, Brazil

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About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of non-squamous NSCLC, Stage IIIB/IIIC incurable or IV/M1.
  • Age ≥ 18 years at diagnosis of advanced/metastatic disease.

AGA Cohort: Presence of actionable mutations and all of the following:

  • failure of platinum-based chemotherapy,
  • failure of ≥ 1 line of approved target therapy or no targeted therapy available at the clinic,
  • additional systemic treatment after platinum + target therapy combination.

Non-AGA Cohort: Absence of actionable mutations and all of the following:

  • failure of platinum-based chemotherapy,
  • failure of immunotherapy concurrent or sequential to platinum,
  • additional systemic treatment after platinum + immunotherapy combination.

Exclusion criteria

  • Patients with evidence of other primary malignancies (except basal cell carcinoma and melanoma) within 1 year prior to the index date will be excluded from both study cohorts.
  • Patients who participated in a clinical investigational study for the treatment of any cancer, including NSCLC, or any early access program from 2018 onwards.

Treatment and study plan

Primary outcomes

  1. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: tumor histology, mutation and PD-L1 status, disease stage at diagnosis

  2. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 21th 2024

    Description of patient population and treatment patterns: disease stage at diagnosis

  3. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 21th 2024

    Description of patient population and treatment patterns: smoking status

  4. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: age

  5. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: gender

  6. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: presence of brain metastasis at diagnosis

  7. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: comorbidities (based on Charlson Comorbity Index)

  8. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: treatments used prior to the index date, their start and end time and response

  9. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: treatments used after the index date

  10. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: weight

  11. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: height

  12. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: weight change between first treatment for metastatic disease and treatment index

  13. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: starting dose of the index treatment

  14. Describe of the population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: duration of therapy

  15. Describe the patient population and treatment patterns

    Time frame: between January 1st 2017 and December 31th 2024

    Description of patient population and treatment patterns: reasons for discontinuation

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: RACE-2L

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2024
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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