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.

Phase 1

• Conditions: Resectable, locally advanced non-small cell lung cancer (NSCLC, N2); MedDRA version: 21.1Level: PTClassification code: 10029519Term: Non-small cell lung cancer stage III Class: 100000004864; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-504536-18-00
• Lead Sponsor: Swiss Group for Clinical Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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)

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified