Non-squamous Non-Small Cell Lung CancerRACE-2LNCT06491862
RACE-2L: Real-World Assessment of Clinical Practice and Outcomes in Non-squamous NSCLC After Failure of Platinum-based Chemotherapy in Brazil
An observational study of Non-squamous Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-squamous Non-Small Cell Lung Cancer
- How many people
- 250 participants
- Where
- 11 sitesBrazil
- Study dates
- 25 Jul 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 treatment start date between January 2017 and December 2024.
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
11 sites in 1 country
Brazil11 sites, 11 recruiting
- Not yet recruiting
Research Site
Belo Horizonte, Minas Gerais, 30110-934
- Not yet recruiting
Research Site
Belo Horizonte, Minas Gerais, 30380-420
- Recruiting
Research Site
Natal, Rio Grande do Norte, 59062-000
- Not yet recruiting
Research Site
Porto Alegre, Rio Grande do Sul, 90560-032
- Not yet recruiting
Research Site
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
Research Site
São Paulo, 01308-050
- Not yet recruiting
Research Site
São Paulo, 01323-001
- Recruiting
Research Site
São Paulo, 01323-020
- Recruiting
Research Site
São Paulo, 01333-010
- Not yet recruiting
Research Site
São Paulo, 01509-010
- Recruiting
Research Site
São Paulo, 05652-900
About this study
Official 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
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.
Read the 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%.
- Conditions
- Non-squamous Non-Small Cell Lung Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: between January 1st 2017 and December 21th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: smoking status
Measured: between January 1st 2017 and December 21th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: age
Measured: between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: gender
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: weight
Measured: between January 1st 2017 and December 31th 2024
Describe the patient population and treatment patterns
Description of patient population and treatment patterns: height
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: between January 1st 2017 and December 31th 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start25 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491862
- Sponsor's protocol ID
- D133HR00041
- Acronym
- RACE-2L
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06491862
- Acronym / sponsor ID
- RACE-2L / D133HR00041
- Conditions
- Non-squamous Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 treatment start date between January 2017 and December 2024.
Key inclusion criteria (10 listed)
- Confirmed diagnosis of non-squamous NSCLC, Stage IIIB/IIIC incurable or IV/M1.
- Age ≥ 18 years at diagnosis of advanced/metastatic disease.
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Non-squamous Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-squamous Non-Small Cell Lung Cancer, run by AstraZeneca at 11 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the patient population and treatment patterns (time frame: between January 1st 2017 and December 31th 2024). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.