Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)PASSATNCT05887011
CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia
An observational study of Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III), run by AstraZeneca at 37 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)
- How many people
- 2,000 participants
- Where
- 37 sitesRussia
- Study dates
- 31 Mar 2023to 30 Jun 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 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.
Who may be able to join
- Age ≥ 18 years old
- Provision of written informed consent
- 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
- Patient is currently undergoing RT (preferably no more than 10 doses)
Who cannot join
- Participation in another clinical study with an investigational product during the last 3 months
- Confirmation that the subject was already included in this study before
- Absence of written informed consent form
- 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 locations and contacts
37 sites in 1 country.
37 sites in 1 country
Russia37 sites
Research Site
Arkhangelsk
Research Site
Balashikha
Research Site
Barnaul
Research Site
Grozny
Research Site
Irkutsk
Research Site
Ivanovo
Research Site
Kaluga
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Khabarovsk
Research Site
Khanty-Mansiysk
Research Site
Kirov
Research Site
Kostroma
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novokuznetsk
Research Site
Novosibirsk
Research Site
Obninsk
Research Site
Perm
Research Site
Podolsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Saransk
Research Site
Saratov
Research Site
Sochi
Research Site
Tula
Research Site
Tver'
Research Site
Ulyanovsk
Research Site
Vladivostok
Research Site
Vologda
Research Site
Yakutia
Research Site
Yaroslavl
Research Site
Yekaterinburg
Research Site
Yuzhno-Sakhalinsk
About this study
Official title: 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.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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 CRT
- of patients with each TNM stage among SCLC
- of 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 SCLC
- of patients by ECOG category among SCLC
Measured: Baseline
Secondary outcomes (16)
Chemoradiotherapy (CRT) details
- % of induction chemotherapy,
Measured: 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
Measured: 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;
Measured: 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);
Measured: 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);
Measured: 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.
Measured: up to 6 month
Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT
Frequency distribution of patients who receive concurrent or sequential CRT
Measured: up to 6 month
Chemoradiotherapy (CRT) details: presence of interruptions
% of CRT interruptions
Measured: up to 6 month
Chemoradiotherapy (CRT) details: number of interruptions
average number of interruptions per patients
Measured: up to 6 month
Chemoradiotherapy (CRT) details: durations of interruptions
median interruption duration (days) (based on mean duration per patient)
Measured: up to 6 month
Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;
frequency distribution of reasons to interrupt or stop RT
Measured: 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
Measured: 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
Measured: 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
Measured: up to 6 month
Chemoradiotherapy (CRT) details
- For ChT: number of chemotherapy courses
Measured: 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)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start31 Mar 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III)Studies 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887011
- Sponsor's protocol ID
- D133HR00026
- Acronym
- PASSAT
- Status last verified
- May 2026
- First submitted
- 21 Apr 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- 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. 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicentre Non-interventional Study to Assess CRT Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia
- ClinicalTrials.gov ID
- NCT05887011
- Acronym / sponsor ID
- PASSAT / D133HR00026
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Jun 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Provision of written informed consent
- 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
- Patient is currently undergoing RT (preferably no more than 10 doses)
Key exclusion criteria (4 listed)
- Participation in another clinical study with an investigational product during the last 3 months
- Confirmation that the subject was already included in this study before
- Absence of written informed consent form
- 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.
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
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.
Time frame: Baseline
* % 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 CRT * of patients with each TNM stage among SCLC * of 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 SCLC * of patients by ECOG category among SCLC
16 secondary outcomes
Chemoradiotherapy (CRT) details
Time frame: 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
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Time frame: up to 6 month
Patterns of routine diagnostics and treatment for patients with unresectable LA NSCLC or LS-SCLC
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: concurrent CRT vs sequential CRT
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: presence of interruptions
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: number of interruptions
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: durations of interruptions
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:Reasons for RT interruptions and dose reductions/ withdrawals;
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:· RT: doses, fractionation, planning, selective and elective irradiation of lymph nodes
Time frame: up to 6 month
Chemoradiotherapy (CRT) details:· Type of platinum-based chemotherapy used
Time frame: up to 6 month
Chemoradiotherapy (CRT) details: For sCRT: duration between ChT and RT
Time frame: up to 6 month
Chemoradiotherapy (CRT) details
Time frame: up to 6 month
Chemoradiotherapy (CRT) details for SCLC
Time frame: Up to 6 months
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 27 May 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. 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.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable /Inoperable Locally Advanced (Stage II-III) NSCLC and Locally Advanced LS-SCLC (Stage I-III), run by AstraZeneca at 37 sites in Russia.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Russia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). 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 27 May 2026.