Small cell lung carcinoma
Conditions
Brief summary
Occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification.
Detailed description
Occurrence of DLTs during the DLT evaluation period, Occurrence of treatment-emergent DLTs, Occurrence of treatment-emergent AESIs, Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Objective response (OR) is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent, Duration of response (DoR), defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments, Disease control(DC), defined as best overall response of complete response(CR) or partial response(PR) or stable disease (SD) where best overall response is defined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 based on investigator assessments from the first IMP administration until the earliest date of disease progression, death or last evaluable tumour assessment before start of the next line of anti-cancer treatment, loss to follow-up or withdrawal of consent, Progression-free survival (PFS) is defined as the time from first IMP administration until the earliest date of disease progression according to RECIST 1.1 based on investigator assessments or death from any cause, whichever occurs first
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of treatment-emergent AEs leading to trial medication discontinuation or dose modification. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs during the DLT evaluation period, Occurrence of treatment-emergent DLTs, Occurrence of treatment-emergent AESIs, Occurrence of treatment-emergent AEs CTCAE Grade ≥3, Objective response (OR) is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator assessments) from the first IMP administration until the earliest date of disease progression, death, last evaluable tumour assessment before the start of the next line of anti-cancer treatment, loss to follow-up, or withdrawal of consent, Duration of response (DoR), defined as the time from the first documented OR according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed objective response based on investigator assessments, Disease control(DC), defined as best overall response of complete response(CR) or partial response(PR) or stable disease (SD) where best overall response | — |