L-AP-IS: Lung cancer, Ablative high Precision radiotherapy and the Immune System: Evaluation of the immune-modulatory effects of stereotactic body radiation therapy (SBRT) of pulmonary lesions

L-AP-IS: Lung cancer, Ablative high Precision radiotherapy and the Immune System: Evaluation of the immune-modulatory effects of stereotactic body radiation therapy (SBRT) of pulmonary lesions - L-AP-IS

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011266

Enrollment

Registered

2017-01-10

Start date

2016-09-06

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C34

Interventions

Group 1: Blood samples of patients with primary or recurrent NSCLC collected before, during and after SBRT (Stereotactic Body RadioTherapy) will be evaluated for immunespecific, circulating biomarkers

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Primary or recurrent non-metastatic NSCLC or • Solitary or oligometastasic pulmonary metastasis of otherwise controlled malignant • Lesions confirmed by either histology or cytology or clear imaging signs of malignant tumors • Patient scheduled and eligible for SBRT with curative intention • Whole body FDG-PET scan + WB-CT or CT of chest and upper abdomen • Written informed consent must be given according to ICH/GCP, and national/local regulations • Adequate birth control measures during the study treatment period

Exclusion criteria

Exclusion criteria: • Other active or significantly bone marrow suppressing malignancy • WHO performance status < 2 • Prior radiotherapy to chest and/or mediastinum within 3 months before the start of SBRT • Chemotherapy and/or targeted treatment within 3 months before the start of SBRT • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule • Pregnancy

Design outcomes

Primary

Measure	Time frame
Increase of CTL counts six weeks after SBRT compared to baseline	—

Secondary

Measure	Time frame
- Significant changes in number and phenotype of lymphocytes - Significant changes in number and phenotype of myeloid cells - Significant changes in circulating biomarkers of immune response in the plasma - Association between treatment related data and changes in different biomarkers of immune response - Association between treatment outcomes and changes in different biomarkers of immune response - Differences in the above mentioned endpoints between patients with or without prior / simultaneous radiation and /or systemic therapy	—

Measure

Time frame

- Significant changes in number and phenotype of lymphocytes - Significant changes in number and phenotype of myeloid cells - Significant changes in circulating biomarkers of immune response in the plasma - Association between treatment related data and changes in different biomarkers of immune response - Association between treatment outcomes and changes in different biomarkers of immune response - Differences in the above mentioned endpoints between patients with or without prior / simultaneous radiation and /or systemic therapy

—

Countries

Germany

Contacts

Public ContactUrsula Nestle

Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

ursula.nestle@uniklinik-freiburg.de+49 761 270-95200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026