Extrapulmonary neuroendocrine carcinoma of large cell histology, Large cell neuroendocrine lung carcinoma, Extrapulmonary neuroendocrine carcinoma of small cell histology, Small cell lung carcinoma
Conditions
Brief summary
Part 1: The occurrence of DLTs during the DLT evaluation period., Part 2: The occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification, Part 2: PFS rate at 6 months according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
Detailed description
Part 1 and Part 2: Occurrence of treatment-emergent DLTs, Part 1 and Part 2: Occurrence of treatment-emergent AESIs, Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Part 1 and Part 2: Objective response (OR), Part 1 and Part 2: Duration of response (DoR), Part 1 and Part 2: Disease control (DC), Part 1: Progression-free survival (PFS), Part 2: Occurrence of DLTs during the DLT evaluation period
Interventions
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The occurrence of DLTs during the DLT evaluation period., Part 2: The occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification, Part 2: PFS rate at 6 months according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2: Occurrence of treatment-emergent DLTs, Part 1 and Part 2: Occurrence of treatment-emergent AESIs, Part 1 and Part 2: Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Part 1 and Part 2: Objective response (OR), Part 1 and Part 2: Duration of response (DoR), Part 1 and Part 2: Disease control (DC), Part 1: Progression-free survival (PFS), Part 2: Occurrence of DLTs during the DLT evaluation period | — |
Outcome results
None listed