Immune-modulatory radiotherapy to enhance the effects 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 trial. - SAKK 16/18

Swiss Group for Clinical Cancer Research0 sites90 target enrollmentJanuary 12, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Resectable, locally advanced non-small cell lung cancer (NSCLC, N2)
Sponsor: Swiss Group for Clinical Cancer Research
Enrollment: 90
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

January 12, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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)

•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\)