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Radiotherapy to enhance the effects of an immune therapy before tumor surgery in patients with advanced non-small cell lung cancer (NSCLC). A multicenter phase II trial.
EU CTIS ID: 2023-504536-18-00
What this study is testing
To evaluate whether the addition of immune-modulatory radiotherapy to standard neoadjuvant chemotherapy with cisplatin/docetaxel and peri-operative immunotherapy with the anti-PD-L1 antibody durvalumab in primarily resectable stage III(N2) NSCLC is efficacious and feasible.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically (cytology is accepted if histology is not possible) confirmed NSCLC (adeno-, squamous-, large cell carcinoma, or NSCLC not otherwise specified (NOS)) irrespective of genomic aberrations or PD-L1 expression status
- Tumor stage T1-4>7 N2 M0 (i.e. T1-3 N2 or T4 N2 but T4 only allowed if due to size > 7cm, not allowed if due to invasion or nodule in different ipsilateral lobe), according to the TNM classification, 8th edition, December 2016. Mediastinal lymph node staging has to follow the process chart.
- Age 18-75 years at time of registration
- WHO performance status 0-1
- Adequate organ function (incl. eGFR ≥ 60 mL/min)
You likely can't join if
- Presence of any distant metastasis or N3 disease. Brain metastases have to be excluded by CT or MRI
- Sulcus superior tumors (Pancoast tumors) or T4 for any other reason than size >7cm
- Any previous treatment for NSCLC
- Any previous treatment with immune checkpoint inhibitors, including durvalumab
- Previous radiotherapy to the chest (with the exception of tangential breast irradiation with minimal dose to lung and mediastinum, and superficial orthovoltage or electron irradiation of localized skin lesions)
- Preexisting peripheral neuropathy (> Grade 1)
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.