Assessment of outcomes in non-squamous lung cancer patients after chemotherapy failure in Brazil

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

This study looks at how well different treatments work for patients in Brazil with advanced non-squamous lung cancer who didn't respond to their initial chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 11 sites (Belo Horizonte, Minas Gerais and 10 other locations)
• Trial ID: NCT06491862 on ClinicalTrials.gov

What this trial studies

This study involves a retrospective review of medical records from patients diagnosed with advanced non-squamous non-small cell lung cancer (NSCLC) who have failed platinum-based chemotherapy. It aims to evaluate clinical practices and outcomes in real-world settings for these patients, focusing on those who have received at least one line of systemic treatment after chemotherapy failure. The study will analyze various subtypes of NSCLC based on genomic mutations and treatment history, providing insights into the effectiveness of subsequent therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced non-squamous NSCLC who have failed platinum-based chemotherapy and have received subsequent systemic treatment.

Not a fit: Patients with other primary malignancies or those who have participated in investigational trials for cancer treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of treatment outcomes and guide future therapeutic strategies for patients with advanced non-squamous NSCLC.

How similar studies have performed: Other studies have shown success in assessing real-world outcomes in similar patient populations, indicating that this approach is supported by prior research.

Eligibility criteria

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.

Where this trial is running

Belo Horizonte, Minas Gerais and 10 other locations

• Research Site — Belo Horizonte, Minas Gerais, Brazil (Not_yet_recruiting)
• Research Site — Belo Horizonte, Minas Gerais, Brazil (Not_yet_recruiting)
• Research Site — Natal, Rio Grande do Norte, Brazil (Recruiting)
• Research Site — Porto Alegre, Rio Grande do Sul, Brazil (Not_yet_recruiting)
• Research Site — São José do Rio Preto, São Paulo, Brazil (Not_yet_recruiting)
• Research Site — São Paulo, Brazil (Recruiting)
• Research Site — São Paulo, Brazil (Not_yet_recruiting)
• Research Site — São Paulo, Brazil (Recruiting)
• Research Site — São Paulo, Brazil (Recruiting)
• Research Site — São Paulo, Brazil (Not_yet_recruiting)
• Research Site — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Non-squamous Non-Small Cell Lung Cancer