2024-515902-15-00
Active, not recruiting
Phase 2
A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung (LCNEC-ALPINE)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Technische Universitaet Dresden
- Enrollment
- 67
- Locations
- 15
- Primary Endpoint
- Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this trial is to evaluate the efficacy of Atezolizumab in addition to standard of care (SoC) chemotherapy for the treatment of LCNEC as measured by overall survival (OS).
Investigators
Prof. Dr. Martin Wermke
Scientific
Technische Universitaet Dresden
Eligibility Criteria
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 (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
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
- •Any prior treatment for metastatic disease
Outcomes
Primary Outcomes
Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)
Secondary Outcomes
- Objective response rate (ORR) defined as partial remission (PR) or complete remission (CR) according to RECIST v1.1
- Immune ORR (iORR) defined as immune PR (iPR) or immune CR (iCR) according to iRECIST
- Disease control rate (DCR) defined as combination of CR, PR and stable disease (SD) according to RECIST v1.1
- Progression free survival (PFS) defined as time from C1D1 to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first
- Immune PFS (iPFS) defined as time from C1D1 to progression according to iRECIST or death from any cause whichever occurs first
- Duration of response (DoR) defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause whichever occurs first
- PFS/ iPFS (according to RECIST v1.1 and iRECIST) rate at 1 year
- OS rate at 1 year
- PFS, OS, DoR and ORR in central pathology confirmed cases of LCNEC
- Incidence, nature, severity of adverse events (grading according to NCI CTCAE (v5.0)
Study Sites (15)
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