Active — Not RecruitingPhase 2

Multimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC)

Germany, Switzerland90 participantsStarted 2020-07-15

Plain-language summary

Resectable, locally advanced NSCLC with involvement of mediastinal lymph nodes (N2) is associated with a high risk of (systemic) recurrence despite neo-adjuvant chemotherapy. Neo-adjuvant immunotherapy is a promising additional treatment modality aiming at increasing local control and better tackling micrometastases at the time of radical local treatment. Radiotherapy is thought to act synergistically with immunotherapy through release of tumor antigens and modulation of the local immune microenvironment in favor of a better antigen-presentation and (systemic) anti-tumor immune response (abscopal effect). The aim of the proposed SAKK 16/18 trial is to evaluate the efficacy and safety of adding immune-modulatory radiotherapy to the SAKK 16/14 treatment regimen by combining neo-adjuvant radio-immunotherapy. Due to the lack of evidence for an optimal radiotherapy regimen for an "in-situ vaccination" effect three different radiotherapy regimens will be tested.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent according to ICH-GCP regulations before registration and prior to any trial specific procedures. * 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 (see Appendix 2). Mediastinal lymph node staging has to follow the process chart. * Tumor is considered resectable based on a multidisciplinary tumor board decision made before neoadjuvant treatment. Resectable is when a complete resection can be achieved according to Rami-Porta * Patients with a prior malignancy (except NSCLC) and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence, after consultation with CI. * Measurable disease per RECIST v1.1 criteria by PET/CT with contrast enhanced CT-scan. * Tumor tissue is available for the mandatory translational research (formalin-fixed; preferably histology, cytology allowed if histology is not po…

What they're measuring

Event-free survival (EFS) at 12 months

Timeframe: at 12 months

Trial details

NCT IDNCT04245514

SponsorSwiss Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-16