A Phase II, single-arm trial of addition of Atezolizumab to standard chemotherapy of Platinum and Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung

Phase 1

• Conditions: locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) not eligible for curative treatment; MedDRA version: 20.0Level: LLTClassification code 10078184Term: Neuroendocrine tumor of the lung metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10078175Term: Neuroendocrine tumour of the lung metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002683-31-DE
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-03
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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:
-ALAT/ASAT =2.5x ULN or =3.5x 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 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.;Secondary Objective: To assess the safety, tolerability and efficacy of Atezolizumab in addition to standard of care (SoC; Platinum/Etoposide) in LCNEC.;Primary end point(s): overall survival (OS) ;Timepoint(s) of evaluation of this end point: time to event endpoint

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary efficacy endpoints (ORR, iORR, DCR, PFS, iPFS, DoR, PFS rate at one year, iPFS rate at one year, OS rate at one year), Safety: Incidence, nature, causality, seriousness and severity of adverse events using NCI CTCAE (v5.0);Timepoint(s) of evaluation of this end point: during whole study and time to event endpoints