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

Phase 2

Active, not recruiting

• Conditions: Male and female adult patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung not eligible for curative treatment

• Registration Number: 2024-515902-15-00
• Lead Sponsor: Technische Universitaet Dresden

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).

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-24
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 67

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Objective response rate (ORR) defined as partial remission (PR) or complete remission (CR) according to RECIST v1.1		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		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		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		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		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		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		PFS/ iPFS (according to RECIST v1.1 and iRECIST) rate at 1 year
OS rate at 1 year		OS rate at 1 year
PFS, OS, DoR and ORR in central pathology confirmed cases of LCNEC		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)		Incidence, nature, severity of adverse events (grading according to NCI CTCAE (v5.0)

Trial Locations

Locations (15)

Klinikum der Universität zu Köln; 🇩🇪 Köln, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH; 🇩🇪 Berlin, Germany

Pius-Hospital Oldenburg; 🇩🇪 Oldenburg, Germany

Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR; 🇩🇪 Dresden, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Lungenfachklinik Immenhausen; 🇩🇪 Immenhausen, Germany

Rems-Murr-Kliniken gGmbH; 🇩🇪 Winnenden, Germany

LungenClinic Grosshansdorf GmbH; 🇩🇪 Grosshansdorf, Germany

Asklepios Klinik Gauting GmbH; 🇩🇪 Gauting, Germany

Scroll for more (5 remaining)

Klinikum der Universität zu Köln

🇩🇪Köln, Germany

Jürgen Wolf

Site contact

022147889050

juergen.wolf@uk-koeln.de