Evaluation of Systemic Effects of Combined Palliative Radiation Therapy and Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer after Insufficient Response to Immune Checkpoint Blockade

Evaluation of Systemic Effects of Combined Palliative Radiation Therapy and Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer after Insufficient Response to Immune Checkpoint Blockade - RadImmun-NSCLC

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013531

Enrollment

Registered

2017-12-04

Start date

2018-03-22

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: Radiation therapy, immunotherapy with approved checkpoint inhibitors, tumor assessment by imaging, collection of blood samples (and biopsy material), evaluation of results

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with metastatic NSCLC and progressive disease; At least three lesions measurable by computed tomography scan or magnetic resonance imaging; Patients presenting the indication for radiation therapy, with a minimum of 2 metastases not amenable to radiation therapy; Mixed or partial response under immunotherapy with checkpoint inhibitors; Minimum life expectancy of 3 months; Adequate bone marrow function; Adequate liver function; Written informed consent must be obtained according to ICH/GCP, and national/local regulations; Adequate birth control measures during the study treatment period.

Exclusion criteria

Exclusion criteria: Age 2; Female subjects who are pregnant; Patients under chronic treatment with systemic immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 1 week prior starting the study treatment; Patients with active, known, or suspected autoimmune disease; Other active or significantly bone marrow-suppressing malignancy or therapy; Known activating EGFR Mutation or a known ALK Translocation; Patients with previous malignancies; Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up.

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR) according to RECIST 1.1 and irRC; Best response of non-target index-lesions and thus evaluation of systemic immune-related effects (abscopal effects)	—

Secondary

Measure	Time frame
Progression-free survival; Acute and late toxicity induced by the combined therapy; Local control achieved by radiation therapy; Overall survival; Quality of life as measured by means of EORTC QLQ-C30 questionnaire	—

Countries

Germany

Contacts

Public ContactIlinca Popp

Klinik für Strahlenheilkunde

ilinca.popp@uniklinik-freiburg.de+49 761 270-94610

Outcome results

None listed

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