Actively Recruiting
Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC
Led by Universität des Saarlandes · Updated on 2024-04-05
43
Participants Needed
5
Research Sites
216 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC
CONDITIONS
Official Title
Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed first diagnosis of extensive-stage small-cell lung cancer (ES-SCLC) according to VALG staging system
- Oligometastatic disease with primary tumor and up to four distant tumor lesions treatable by radiotherapy
- No cytologically confirmed malignant pleural effusion
- Stable disease or partial response after two cycles of platinum/etoposide/durvalumab
- Adequate lung function with forced expiratory volume in first second (FEV1) 1.3 liters
- Able to give signed informed consent
- Age greater than 18 years
- ECOG performance status 0 or 1
- Body weight over 30 kg
- Adequate organ and marrow function including specific blood counts and liver and kidney function
- Willing and able to comply with study protocol and follow-up
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Participation in another investigational clinical study within last 4 weeks
- Concurrent enrollment in another interventional clinical study
- Prior systemic anticancer therapy other than two cycles of platinum/etoposide/durvalumab
- Unresolved toxicity grade 2 or higher from previous chemo-immunotherapy except alopecia, vitiligo, and defined lab values
- Concurrent chemotherapy, investigational product, biologic, or hormonal cancer therapy
- Radiotherapy to more than 30% of bone marrow or wide field radiation within 4 weeks before study drug
- Major surgery within 28 days before first dose except palliative local surgery
- History of allogenic organ transplantation
- Active or prior autoimmune or inflammatory disorders except certain stable or controlled conditions
- Uncontrolled illness including infection, heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, serious gastrointestinal conditions, psychiatric illness
- History of other primary malignancies with exceptions
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Known active hepatitis infection or positive hepatitis B or C markers with exceptions
- Known HIV infection or active tuberculosis
- Recent use of immunosuppressive medication with exceptions
- Receipt of live vaccine within 30 days before first dose
- Pregnancy, breastfeeding, or unwillingness to use effective birth control
- Known allergy or hypersensitivity to study drugs or excipients
- Prior randomization or treatment in previous durvalumab clinical study
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University Hospital Augsburg, Radiation Oncology
Augsburg, Bavaria, Germany, 86156
Actively Recruiting
2
University Hospital Erlangen, Radiation Oncology
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
3
University Hospital Regensburg, Clinic and Polyclinic for Radiotherapy
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
4
Kliniken Maria Hilf
Mönchengladbach, North Rhine-Westphalia, Germany, 41063
Actively Recruiting
5
Saarland University Medical Center and Saarland University Faculty of Medicine, Clinic for Radiotherapy and Radiooncology
Homburg, Saarland, Germany, 66421
Actively Recruiting
Research Team
W
Wiebke Pirschel, M.Sc.
CONTACT
M
Markus Hecht, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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