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

Not Applicable

Recruiting

Conditions: C34
Malignant neoplasm of bronchus and lung

Registration Number: DRKS00013531

Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

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

Age < 18 years; Central nervous system metastases mandating active treatment; ECOG performance status > 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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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