A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Ne… (NCT05470595) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
Germany67 participantsStarted 2022-01-18
Plain-language summary
This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 (SoC)
✓. ECOG performance status: 0-2
✓. age ≥18 years
✓. measurable disease according to RECIST v1.1
✓. adequate organ function defined as:
Exclusion criteria
✕. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
✕. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
✕. Severe uncontrolled infection
✕. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor