Kliniken & Institute … Kliniken Radiologische Klinik … RadioOnkologie und… Forschung FORCE-Studie

FORCE Studie

Fostering efficacy of anti – PD-1 – treatment: Nivolumab plus radiotherapy in advanced NSCLC.

Einschlusskriterien

  • Age ≥ 18 years
  • ECOG performance status 0-1
  • Metastatic non-squamous NSCLC after failure of platinum-based doublet chemotherapy and
    i.) the necessity of RT of a metastatic bone or soft tissue lesion (group A) or
    ii.) no necessity of RT (group B)
  • Presence of measurable disease by CT or MRI per RECIST 1.1 criteria
  • FFPE material for PD-L1 evaluation must be available.

Aussschlusskriterien

  • Previous malignancies
  • Known activating EGFR mutation or a known ALK translocation
  • Prior immunotherapy
  • Ongoing treatment with >10mg of prednisone (or steroid equivalent) daily
  • Active or recent history of an autoimmune disease or syndrome that required systemic corticosteroids/ immunosuppressive medications
  • Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • Brain metastases mandating active treatment in terms of irradiation. Subjects with brain metastases are eligible, if metastases have been treated, treatment has been completed,and no progression is evident on MRI, or if metastases are stable/asymptomatic and do not require local therapy with irradiation.