A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

Phase 2

Active, not recruiting

• Conditions: Large Cell Neuroendocrine Carcinoma of the Lung
• Interventions: Drug: Atezolizumab

• Registration Number: NCT05470595
• Lead Sponsor: Technische Universität Dresden

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2028-01-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Written informed consent

2. 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%)

3. 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)

4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)

5. ECOG performance status: 0-2

6. age ≥18 years

7. measurable disease according to RECIST v1.1

8. adequate organ function defined as:

   1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
   2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
   3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min
   4. Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis

Exclusion Criteria

1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
3. Severe uncontrolled infection
4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
5. Any prior treatment for metastatic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atezolizumab/Platinum/Etoposide	Atezolizumab	Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.

Primary Outcome Measures

Name	Time	Method
Overall survival	appr. 72 months	To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	appr. 72 months	According to RECIST v1.1 as assessed by local investigator.
Immune Objective Response Rate (iORR)	appr. 72 months	According to iRECIST as assessed by local investigator.
Immune Progression Free Survival (iPFS)	appr. 72 months
Duration of Response (DoR)	appr. 72 months
Progression Free Survival (PFS)	appr. 72 months
Progression Free Survival (PFS) rate at one year	1 year
Immune Progression Free Survival (iPFS) rate at one year	1 year
Overall survival at one year	1 year
Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).	appr. 72 months
Objective Response Rate (ORR)	appr. 72 months	According to RECIST v1.1 as assessed by local investigator.

Trial Locations

Locations (15)

Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik; 🇩🇪 Berlin, Germany

Evangelische Lungenklinik; 🇩🇪 Berlin, Germany

Universitätsklinikum Dresden, Medizinische Klinik 1; 🇩🇪 Dresden, Germany

Klinikum der J.W. Goethe Universität, Medizinische Klinik II; 🇩🇪 Frankfurt am Main, Germany

Asklepios Fachkliniken München-Gauting; 🇩🇪 Gauting, Germany

LungenClinic Grosshansdorf GmbH; 🇩🇪 Großhansdorf, Germany

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH; 🇩🇪 Halle (Saale), Germany

Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH; 🇩🇪 Hemer, Germany

Lungenfachklinik Immenhausen; 🇩🇪 Immenhausen, Germany

Klinikum der Universität zu Köln, Klinik I für Innere Medizin; 🇩🇪 Köln, Germany

Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik; 🇩🇪 Mainz, Germany

Pius Hospital, Klinik für Hämatologie und Onkologie; 🇩🇪 Oldenburg, Germany

Robert-Bosch-Krankenhaus GmbH; 🇩🇪 Stuttgart, Germany

Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin; 🇩🇪 Winnenden, Germany