Actively Recruiting
Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab for Initially Unresectable Stage III Non-Small Cell Lung Cancer
Led by Idris Bahce · Updated on 2025-04-03
38
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer, especially stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery at first, is challenging to treat. Researchers are studying whether surgery after chemoradiotherapy (CRT) followed by durvalumab immunotherapy can improve outcomes. This phase IV trial focuses on patients with initially unresectable stage III NSCLC without N3 lymph node involvement, aiming to see if adding surgery after CRT is feasible and beneficial. Participants will first receive concurrent chemoradiotherapy using platinum-based chemotherapy and high-dose radiotherapy. If the tumor becomes operable, they will undergo surgery followed by consolidation therapy with durvalumab, an immunotherapy drug. The study evaluates this combined approach's safety and feasibility, including rates of surgical complications and the ability to proceed to durvalumab treatment. Throughout the study, participants will be closely monitored for serious side effects within 90 days after surgery and for treatment-related adverse events. Researchers will also assess how many patients can receive durvalumab after surgery and measure outcomes like the completeness of tumor removal and disease-free survival two years post-surgery. The total participation time varies, with regular visits and examinations planned to track treatment effects and safety.
CONDITIONS
Brief Title
Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage III (non-N3) NSCLC before starting concurrent chemoradiotherapy
- Mediastinal invasive staging preferred if N2 disease is suspected before chemoradiotherapy
- Initial recommendation for concurrent chemoradiotherapy followed by durvalumab
- Able to provide signed informed consent including compliance with study requirements
- Age older than 18 years at study entry
- Performance status of 0-1 on ECOG scale at restaging
- Body weight over 30 kg
- Adequate normal organ and marrow function as judged by treating physician
- Willing and able to comply with study treatment, visits, and follow-up
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Patients with TxN3 or metastatic (M1) disease
- Known actionable genomic alterations
- Use of chemoradiotherapy schemes not following ESMO platinum doublet and 60 Gy in 30 fractions
- Inoperable based on cardiopulmonary tests or comorbidities
- Unable to undergo CT scan with intravenous contrast
- Unable to remain lying down for 15 minutes for PET-low-dose CT scan
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other immune checkpoint drugs
- Participation in another investigational clinical study within last 4 weeks
- Concurrent enrollment in another clinical study except observational or follow-up studies
- Unresolved toxicity grade 2 or higher from previous cancer therapy (except alopecia, vitiligo)
- Received last anticancer therapy less than 4 weeks before study drug
- Concurrent chemotherapy, investigational product, biologic, or hormonal cancer therapy
- Major surgery within 28 days before first study drug dose
- History of allogenic organ transplant
- Active or prior autoimmune or inflammatory disorders except some controlled exceptions
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, interstitial lung disease, serious GI conditions, or psychiatric/social issues limiting compliance
- History of other primary malignancy unless treated with curative intent more than 5 years ago
- History of leptomeningeal carcinomatosis
- History of active primary immunodeficiency
- Known active hepatitis or certain viral infections at screening
- Known HIV infection or active tuberculosis
- Immunosuppressive medication use within 14 days before durvalumab except limited steroid use
- Receipt of live attenuated vaccine within 30 days before study drug
- Pregnancy or breastfeeding or unwillingness to use effective birth control
- Known allergy to study drugs or excipients
- Prior participation or randomization in durvalumab clinical studies
- Investigator judgment of unsuitability or likely non-compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 weeks
Participants receive concurrent chemoradiotherapy as initial treatment.
Duration - Up to 90 days post-surgery
Participants undergo surgery to remove the tumor if deemed resectable, followed by immediate post-operative care.
1 surgery and approximately 6 post-operative visits
Duration - Up to 2 months
Participants receive consolidation durvalumab after surgery to help prevent cancer recurrence.
Weekly visits during consolidation durvalumab treatment
Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VU Medical center
Amsterdam, Netherlands
Actively Recruiting
Research Team
C
Chris Dickhoff, MD, PhD
I
Ilias Houda, MD
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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