RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil
RACE-2L
1 other identifier
observational
250
1 country
11
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 2024.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2024
CompletedFirst Posted
Study publicly available on registry
July 9, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
April 21, 2026
April 1, 2026
1.9 years
June 11, 2024
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (15)
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: tumor histology, mutation and PD-L1 status, disease stage at diagnosis
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: disease stage at diagnosis
between January 1st 2017 and December 21th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: smoking status
between January 1st 2017 and December 21th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: age
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: gender
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: presence of brain metastasis at diagnosis
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: comorbidities (based on Charlson Comorbity Index)
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: treatments used prior to the index date, their start and end time and response
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: treatments used after the index date
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: weight
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: height
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: weight change between first treatment for metastatic disease and treatment index
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: starting dose of the index treatment
between January 1st 2017 and December 31th 2024
Describe of the population and treatment patterns
Description of patient population and treatment patterns: duration of therapy
between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: reasons for discontinuation
between January 1st 2017 and December 31th 2024
Eligibility Criteria
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 2024.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (11)
Research Site
Belo Horizonte, Minas Gerais, 30110-934, Brazil
Research Site
Belo Horizonte, Minas Gerais, 30380-420, Brazil
Research Site
Natal, Rio Grande do Norte, 59062-000, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Research Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
Research Site
São Paulo, 01308-050, Brazil
Research Site
São Paulo, 01323-001, Brazil
Research Site
São Paulo, 01323-020, Brazil
Research Site
São Paulo, 01333-010, Brazil
Research Site
São Paulo, 01509-010, Brazil
Research Site
São Paulo, 05652-900, Brazil
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2024
First Posted
July 9, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.