Actively Recruiting
Chemoradiotherapy With Surgery Followed by Consolidation Durvalumab
Led by Idris Bahce · Updated on 2025-04-03
38
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Lung cancer presents a significant treatment challenge, particularly in the heterogeneous stage III NSCLC patient population. While chemotherapy combined with high-dose radiotherapy (60 Gy in 30 fractions of 2 Gy once daily) is currently the recommended approach for unresectable stage III cases, it is associated with significant rates of locoregional and distant failures. Notably, the introduction of durvalumab consolidation therapy after chemoradiotherapy (CRT), as demonstrated in the PACIFIC study, has shown improved overall survival, primarily attributed to enhanced distant control. This improvement prompts further interest in investigating whether further improvements in locoregional control can lead to improved survival for patients. The present study aims to evaluate the feasibility of post-CRT surgery in patients with initially considered unresectable stage III (non-N3) NSCLC.
CONDITIONS
Official 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 (CRT).
- If N2 disease is suspected, invasive mediastinal staging (EUS, EBUS, or mediastinoscopy) is preferred before CRT.
- Initial recommendation for non-surgical treatment with concurrent CRT (platinum-doublet chemotherapy and 60 Gy radiotherapy in 30 fractions) followed by durvalumab.
- Able to provide signed informed consent and comply with study requirements.
- Aged over 18 years at the time of consent.
- Performance status of 0-1 on the ECOG scale at restaging.
- Body weight over 30 kg.
- Adequate organ and marrow function as judged by the treating physician.
- Willing and able to follow the study protocol, including treatments and scheduled visits.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Presence of TxN3 or metastatic (M1) disease.
- Known actionable genomic alterations.
- Use of chemoradiotherapy schemes other than platinum doublet and 30 fractions of 2 Gy.
- Deemed inoperable based on heart and lung function tests or other comorbidities.
- Unable to undergo CT scan with intravenous contrast.
- Unable to lie flat for 15 minutes for PET-low-dose CT scan.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or drugs targeting immune checkpoints.
- Participation in another investigational clinical study within 4 weeks.
- Concurrent enrollment in another interventional clinical study.
- Unresolved toxicities grade 2 or higher from prior cancer therapy, except certain exceptions.
- Last anticancer therapy dose less than 4 weeks before study drug.
- Concurrent chemotherapy, investigational products, biologic, or hormonal therapy for cancer treatment (except certain hormonal therapies).
- Major surgery within 28 days before study drug.
- History of allogenic organ transplantation.
- Active or prior autoimmune or inflammatory disorders, except specified exceptions.
- Uncontrolled illnesses that increase risk or limit study compliance.
- History of other primary malignancies unless treated and disease-free for over 5 years or specific exceptions.
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Active hepatitis infection or positive viral markers, except certain resolved infections.
- Positive HIV test or active tuberculosis infection.
- Recent use of immunosuppressive medication within 14 days before durvalumab, with some exceptions.
- Receipt of live attenuated vaccine within 30 days before study drug.
- Pregnancy, breastfeeding, or unwillingness to use effective birth control.
- Allergy or hypersensitivity to study drugs or excipients.
- Prior participation in a durvalumab clinical trial.
- Investigator judgment that patient is unsuitable or unlikely to comply with study requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location VU Medical center
Amsterdam, Netherlands
Actively Recruiting
Research Team
C
Chris Dickhoff, MD, PhD
CONTACT
I
Ilias Houda, MD
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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