Neoadjuvant immunotherapy is a promising additional treatment method aimed at improving local control and better combating micrometastases at the time of radical local treatment. It is assumed that radiotherapy works synergistically with immunotherapy and results in better antigen presentation and (systemic) anti-tumor immune response (copying effect).
Aim of the study
With this study, we want to test a new treatment option for patients with locally advanced non-small cell lung cancer (NSCLC). The question is whether additional tumor irradiation can improve the effect of immunotherapy prior to tumor surgery.
Who can take part?
Patients with resectable, locally advanced NSCLC with involvement of mediastinal lymph nodes (N2)
Procedure
The study consists of three phases: Preliminary examination, treatment and follow-up. During the preliminary examination phase, numerous tests are carried out to determine your state of health and your suitability for the study. The treatment itself is divided into four phases: 1. chemotherapy with cisplatin and docetaxel for 9 weeks (standard therapy). The medication is administered intravenously as an infusion.2. Immunotherapy and radiotherapy (study-specific therapy): You will receive an infusion with the drug durvalumab. Radiotherapy begins on the same day and lasts either one or four weeks.3. Surgery with removal of the tumor (standard therapy)4. Adjuvant (complementary) immunotherapy that begins within six weeks of surgery (study-specific therapy). They receive an infusion of the drug durvalumab every four weeks for a year, and regular follow-up checks are carried out during the follow-up phase: every three months for the first two years, every six months for the next three years and once a year from the sixth year onwards.
Compensation
None
Original study name
Immunomodulatory radiotherapy to enhance the effect of neoadjuvant PD-L1 blockade after neoadjuvant chemotherapy in patients with resectable stage III (N2) non-small cell lung cancer (NSCLC): A multicenter phase II study
BASEC number
2019-02378
Financial support from
Swiss Association for Clinical Cancer Research (SAKK)