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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

Interested in participating?

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

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 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

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
Jul 22, 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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