Radiation for Oligoprogression or Oligopersistence in NSCLC with Molecular Driver Alteration – a Prospective Observational Cohort Study

Radiation for Oligoprogression or Oligopersistence in NSCLC with Molecular Driver Alteration – a Prospective Observational Cohort Study - ROSA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00041130

Enrollment

Registered

2026-07-28

Start date

2026-08-24

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C34.9

Interventions

Group 1: Single observational cohort: Adults with histologically confirmed NSCLC or SCLC who are receiving or are planned to start an approved targeted treatment are included

for SCLC, this includes treatment with tarlatamab. In addition, a clinical indication for palliative radiotherapy of one or more lesions for local symptom control or due to oligoprogressive or oligope

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: * Provision of written informed consent before the start of data collection. * Provision of DZL Broad Consent. * Histologically confirmed non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC). * Ongoing or planned targeted treatment according to marketing authorisation; for SCLC, treatment with tarlatamab. * A clinical indication for palliative radiotherapy of one or more lesions established independently of the study, either for local symptom control of the primary tumor or a metastasis or for oligoprogressive or oligopersistent metastases. Radiotherapy may be conventional or stereotactic. Irradiated metastatic sites may include bone, solid-organ or soft-tissue lesions; the initial size of brain metastases must be below 3 cm. * ECOG performance status 0–2.

Exclusion criteria

Exclusion criteria: Concurrent participation in another clinical study, unless it is a non-interventional observational study or the participant is only in the follow-up phase of an interventional study.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the safety and tolerability of continuing systemic anticancer treatment—targeted therapy for NSCLC or tarlatamab for SCLC—during clinically indicated radiotherapy. The frequency, time to onset and severity of adverse events are recorded. Adverse events are graded according to the Common Terminology Criteria for Adverse Events, version 5.0. Adverse events of special interest are pneumonitis, interstitial lung disease, radiation pneumonitis, radionecrosis and congestive heart failure. Events are prospectively recorded from study inclusion during radiotherapy and throughout the individual 24-month follow-up using clinical documentation and diagnostic findings available from routine care. The assessment of pneumonitis considers symptoms, clinical examination, imaging, pulmonary function testing and, where available, bronchoscopy findings. The assessment of a possible drug-related or radiation-related cause considers the time of onset and the location within or outside the irradiated area.	—

Measure

Time frame

The primary outcome is the safety and tolerability of continuing systemic anticancer treatment—targeted therapy for NSCLC or tarlatamab for SCLC—during clinically indicated radiotherapy. The frequency, time to onset and severity of adverse events are recorded. Adverse events are graded according to the Common Terminology Criteria for Adverse Events, version 5.0. Adverse events of special interest are pneumonitis, interstitial lung disease, radiation pneumonitis, radionecrosis and congestive heart failure. Events are prospectively recorded from study inclusion during radiotherapy and throughout the individual 24-month follow-up using clinical documentation and diagnostic findings available from routine care. The assessment of pneumonitis considers symptoms, clinical examination, imaging, pulmonary function testing and, where available, bronchoscopy findings. The assessment of a possible drug-related or radiation-related cause considers the time of onset and the location within or outside the irradiated area.

—

Secondary

Measure	Time frame
1. Progression-free survival: Assessment of progression-free intervals before the first radiotherapy and after the first and, where applicable, subsequent radiotherapy courses as PFS0, PFS1, PFS2 and PFS3. Disease progression is documented based on clinical and imaging-based tumor assessments performed as part of routine care. Outcomes are assessed during the individual 24-month follow-up. 2. Time to treatment failure: Time from the start of targeted therapy to its permanent discontinuation for any reason, including disease progression, toxicity or death. 3. Local tumor control: Assessment of local progression of each irradiated lesion based on routine clinical and imaging follow-up, particularly one year after the respective radiotherapy. 4. Overall survival: Time from the start of targeted therapy to death from any cause. For participants without a documented death, the last known contact is considered. 5. Quality of life: Assessment using the EORTC QLQ-C30 questionnaire at study inclusion and during the 24-month follow-up. 6. Exploratory biomarker outcomes: Analysis of results from routinely collected blood samples and, where available, FFPE tumor tissue obtained before study inclusion. Potential associations between biomarkers, baseline characteristics and clinical outcomes are investigated. 7. Radiotherapy characteristics: Assessment of the irradiated target volume and the type of radiotherapy, classified as conventional or stereotactic radiotherapy.	—

Measure

Time frame

1. Progression-free survival: Assessment of progression-free intervals before the first radiotherapy and after the first and, where applicable, subsequent radiotherapy courses as PFS0, PFS1, PFS2 and PFS3. Disease progression is documented based on clinical and imaging-based tumor assessments performed as part of routine care. Outcomes are assessed during the individual 24-month follow-up. 2. Time to treatment failure: Time from the start of targeted therapy to its permanent discontinuation for any reason, including disease progression, toxicity or death. 3. Local tumor control: Assessment of local progression of each irradiated lesion based on routine clinical and imaging follow-up, particularly one year after the respective radiotherapy. 4. Overall survival: Time from the start of targeted therapy to death from any cause. For participants without a documented death, the last known contact is considered. 5. Quality of life: Assessment using the EORTC QLQ-C30 questionnaire at study inclusion and during the 24-month follow-up. 6. Exploratory biomarker outcomes: Analysis of results from routinely collected blood samples and, where available, FFPE tumor tissue obtained before study inclusion. Potential associations between biomarkers, baseline characteristics and clinical outcomes are investigated. 7. Radiotherapy characteristics: Assessment of the irradiated target volume and the type of radiotherapy, classified as conventional or stereotactic radiotherapy.

—

Countries

Germany

Contacts

Public ContactAmanda Tufman

Klinikum der Universität München; Medizinische Klinik und Poliklinik V – Pneumologie und Thorakale Onkologie

Amanda.Tufman@med.uni-muenchen.de+49 89 4400 5-5445

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026