CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia (PASSAT)

AstraZeneca

Status: Enrolling

Conditions: Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)

Study type: Observational

Funder types: Industry

Identifiers

NCT05887011

D133HR00026

Details and patient eligibility

About

This is a multi-center, non-interventional, study with the aim to access routine practice of diagnostic and treatment approaches in patients with NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The data for all 2000 patients with LA NSCLC and LS-SCLC who receiving CRT will have been collected for 2 years from the primary medical records. Demographic and clinical characteristics of the patients, information of routine diagnostics procedures and treatment approaches for patients with unresectable LA NSCLC and LS-SCLC and the treatment results of the end of CRT will be collected. Information about any specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study. Patients with NSCLC and SCLC meeting the inclusion criteria will be prospectively enrolled into the study. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). Study design considers secondary data collection approach using existing patients' medical records, after patients' visits according to routine sites' practice. Data for visit (record) 1 will be collected at the start of CRT (concurrent or sequential), and data for visit (record) 2 will be collected after the last dose of RT and with CT control results available, but the time frame for this data collection is expected to be no later than 6 months after visit 1.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old
2. Provision of written informed consent
3. Patient received at least one RT dose under prescribed CRT (concurrent or sequential) for definitive treatment of locally advanced NSCLC (stage II-III, unresectable or inoperable NSCLC, including locoregional recurrence and patient's refusal to undergo surgery) or LS-SCLC based on local MDT decision
4. Patient is currently undergoing RT (preferably no more than 10 doses)

Exclusion criteria

1. Participation in another clinical study with an investigational product during the last 3 months
2. Confirmation that the subject was already included in this study before
3. Absence of written informed consent form
4. Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.

Trial design

2,000 participants in 2 patient groups

LA NSCLC

Description:

unresectable/inoperable (stage II-III) locally advanced Non-Small Cell Lung Cancer

LS-SCLC

Description:

unresectable/inoperable Limited-stage small cell lung carcinoma (stage I-III)