A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung (LCNEC-ALPINE)

Prior treatment

• Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
• Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
• Any prior treatment for metastatic disease

Other illness

• Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
• Severe uncontrolled infection

• Written informed consent
• Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
• Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
• Planned treatment with Carboplatin or Cisplatin and Etoposide (standard of care - SoC)
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
• age ≥18 years
• measurable disease according to RECIST v1.1
• adequate organ function defined as: Alanine Aminotransferase (ALAT) / Aspartate Aminotransferase (ASAT) ≤2.5x ULN or ≤3.5x Upper limit of Normal (ULN) in case of liver metastases; Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases; Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min; Neutrophils ≥1 Gigaparticle (Gpt)/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis