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

National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Russia
  • Arkhangelsk, Russia
    • Research Site
  • Balashikha, Russia
    • Research Site
  • Barnaul, Russia
    • Research Site
  • Grozny, Russia
    • Research Site
  • Irkutsk, Russia
    • Research Site
  • Ivanovo, Russia
    • Research Site
  • Kaluga, Russia
    • Research Site
  • Kazan', Russia
    • Research Site
  • Kemerovo, Russia
    • Research Site
  • Khabarovsk, Russia
    • Research Site
  • Khanty-Mansiysk, Russia
    • Research Site
  • Kirov, Russia
    • Research Site
  • Kostroma, Russia
    • Research Site
  • Krasnodar, Russia
    • Research Site
  • Krasnoyarsk, Russia
    • Research Site
  • Moscow, Russia
    • Research Site
  • Nizhny Novgorod, Russia
    • Research Site
  • Novokuznetsk, Russia
    • Research Site
  • Novosibirsk, Russia
    • Research Site
  • Obninsk, Russia
    • Research Site
  • Perm, Russia
    • Research Site
  • Podolsk, Russia
    • Research Site
  • Rostov-on-Don, Russia
    • Research Site
  • Ryazan, Russia
    • Research Site
  • Saint Petersburg, Russia
    • Research Site
  • Saransk, Russia
    • Research Site
  • Saratov, Russia
    • Research Site
  • Sochi, Russia
    • Research Site
  • Tula, Russia
    • Research Site
  • Tver', Russia
    • Research Site
  • Ulyanovsk, Russia
    • Research Site
  • Vladivostok, Russia
    • Research Site
  • Vologda, Russia
    • Research Site
  • Yakutia, Russia
    • Research Site
  • Yaroslavl, Russia
    • Research Site
  • Yekaterinburg, Russia
    • Research Site
  • Yuzhno-Sakhalinsk, Russia
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include 2000 patients who received chemoradiotherapy (cCRT or sCRT) for the treatment of locally advanced NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The total enrolment period will take up to 2 years. Information about specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LA NSCLC; unresectable/inoperable (stage II-III) locally advanced Non-Small Cell Lung Cancer
LS-SCLC; unresectable/inoperable Limited-stage small cell lung carcinoma (stage I-III)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic and clinical characteristics of the population. NSCLC stage by TNM classification (% of patients). Patient status - locoregional recurrence and inoperable. Histology type. % of patients with known PD-L1 status and EGFR mutation status.	% of patients with each TNM stage; % of patient with locoregional recurrence and inoperable patients (including patient's refusal); Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications,; % of patients by ECOG category;; % of patients with each tumour histology type;; % of patients with known PD-L1 status (and of those - % positive);; % of patients with known EGFR mutation status (and of those % by mutation status).of patients with SCLC from all patients with locally or locally advanced LC receiving CRTof patients with each TNM stage among SCLCof pts with locoregional recurrence and inoperable pts among SCLC (including pt's refusal Median age at the start of CRTs, % male/female, % of patients with comorbidities (and % by comorbidity type by MedDRA SOC/PT), % on concomitant medications among SCLCof patients by ECOG category among SCLC	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemoradiotherapy (CRT) details	· % of induction chemotherapy,	up to 6 month
Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT	Frequency distribution of patients who receive concurrent or sequential CRT	up to 6 month
Chemoradiotherapy (CRT) details: presence of interruptions	% of CRT interruptions	up to 6 month
Chemoradiotherapy (CRT) details: number of interruptions	average number of interruptions per patients	up to 6 month
Chemoradiotherapy (CRT) details: durations of interruptions	median interruption duration (days) (based on mean duration per patient)	up to 6 month
Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;	frequency distribution of reasons to interrupt or stop RT	up to 6 month
Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes	frequency distribution of the number of RT fractions received	up to 6 month
Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used	Frequency distribution of number chemotherapy courses, of types of platinum chemotherapy used	up to 6 month
Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT	For sCRT: range and median number of chemotherapy courses, median days between chemotherapy and radiotherapy	up to 6 month
Chemoradiotherapy (CRT) details	· For ChT: number of chemotherapy courses	up to 6 month
The short-term effectiveness results of the initial CRT treatment administered to patients with recently first diagnosed LA NSCLC or LS-SCLC (% of patients with CR, PR, ORR, SD, PD, unevaluable for response) for cCRT and sCRT respectively	% of patients with CR,; % of patients with PR,; % of patients with OR (ORR),; % of patients with SD,; % of patients with PD,; % of patients unevaluable for response	up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC	Frequency distribution of each diagnostic approach applied;	up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC	Median time between the date patient first came to oncology center and the date of examination (by each approach);	up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC	Median time between the date of examination and date of start of CRT (by each approach);	up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC	Frequency distribution of results by categories (for example, staging, size, location, etc.) for each approach.	up to 6 month
Chemoradiotherapy (CRT) details for SCLC	Frequency distribution of the number of RT and doses received per day (2x1,5 Gy or 1X2 or 3 Gy)	Up to 6 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D133HR00026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request 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 shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No