Large Cell Neuroendocrine Carcinoma of the Lung
Conditions
Keywords
Lung Cancer, LCNEC, Neuroendocrine Carcinoma
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.
Interventions
DRUGAtezolizumab
Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be followed by maintenance with atezolizumab monotherapy until progression.
Sponsors
Technische Universität Dresden
Roche Pharma AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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. |
| Disease Control Rate (DCR) | appr. 72 months | According to RECIST v1.1 as assessed by local investigator. |
| Progression Free Survival (PFS) | appr. 72 months | — |
| Immune Progression Free Survival (iPFS) | appr. 72 months | — |
| Duration of Response (DoR) | 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 | — |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORMartin Wermke, Prof. Dr.
Technische Universität Dresden (TUD)
Outcome results
None listed