Actively Recruiting
Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC
Led by University Hospital, Bonn · Updated on 2026-01-27
176
Participants Needed
5
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods.
CONDITIONS
Official Title
Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent and comply with study requirements
- Aged 18 to less than 75 years
- All sexes and genders eligible
- Use effective contraception if of childbearing potential during and after treatment as specified
- Post-menopausal status or negative pregnancy test for pre-menopausal women
- Histologically or cytologically confirmed NSCLC (EGFR mutation-negative, ALK-negative)
- NSCLC stage IIIA (T1/T2 N2) or IIIB (T3/T4 N2) with lymph node involvement
- ECOG performance status of 0 or 1
- Tumor technically and oncologically completely resectable (R0) at inclusion
- Sufficient functional reserves and clinical condition for planned surgery and multimodality treatment
- Life expectancy greater than 12 weeks
- Body weight over 30 kg
- Adequate organ and bone marrow function including hemoglobin ≥ 9.0 g/dL, neutrophil count ≥ 1.5 x 10⁹/L, platelet count ≥ 100 x 10⁹/L, bilirubin ≤ 1.5 x institutional upper limit, liver enzymes ≤ 2.5 x institutional upper limit, creatinine clearance ≥ 60 mL/min
- Stable cardiac function without recent myocardial infarction or severe heart failure
- Multidisciplinary tumor board supports participation and both surgery and chemoradiotherapy are possible
- At time of randomization, still meet criteria for complete resectability, sufficient reserves, and organ function
You will not qualify if you...
- Unresectable disease
- Mixed tumor histology with small cell carcinoma areas
- ALK-positive or EGFR-mutated disease
- Symptomatic vena cava superior syndrome
- Diffuse mediastinal involvement
- N3 tumors
- Invasion of thoracic aorta, heart (except left atrium), esophagus, or spine (except diaphragm)
- Pancoast syndrome in superior sulcus tumors
- Metastatic disease
- Extension of tumor to contralateral main stem bronchus
- Lung or heart function unsuitable for surgery
- Prior mediastinal irradiation or prior durvalumab clinical study randomization
- Insufficient compliance or refusal to participate
- Previous immunotherapy with serious or unresolved immune-related adverse events
- Participation in other investigational treatment studies recently
- History of certain lung diseases including pulmonary fibrosis or pneumonitis
- Concurrent cancer treatments outside study therapy
- Major surgery within 28 days before durvalumab
- History of organ or stem cell transplantation
- Active or prior autoimmune or inflammatory disorders except some exceptions
- Uncontrolled illness or infections including HIV, hepatitis B/C except resolved cases
- Recent use of immunosuppressive or immunostimulatory medications
- Receipt of live attenuated vaccine within 30 days prior
- Pregnancy or breastfeeding or unwillingness to use birth control
- Allergy to study drugs or excipients
- Contraindications to platinum-based chemotherapy
- Investigator judgment of unsuitability or likely noncompliance
- At randomization, unresolved toxicity or allergy to study drugs from prior immunochemotherapy
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
2
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
3
University Hospital Gießen
Giessen, Hesse, Germany, 35392
Not Yet Recruiting
4
Johannes Wesling Klinikum Minden Mühlenkreiskliniken, Hämatologie und Onkologie
Minden, North Rhine-Westphalia, Germany, 32429
Actively Recruiting
5
University Hospital Bonn
Bonn, Germany, 53127
Actively Recruiting
Research Team
E
Eleni Gkika, Prof. Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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