Unresectable/metastatic Small cell Lung Cancer (SCLC)
Conditions
Brief summary
Dose-Escalation (Phase 1) Primary Endpoint(s): • Maximum tolerated dose (MTD): based on the incidence of DLTs observed at the end of Cycle 1 (21 days). • Recommended phase 2 dose (RP2D): dose selected for the use in the expansion phase. The RP2D will be determined in discussion with the Investigators and the Sponsor based on safety (dose limiting toxicity), PK, PD, and efficacy observed across multiple dose-escalation cohorts., Expansion-Phase (Phase 2) Primary Endpoint: The primary endpoint for the Expansion-Phase is the Overall Response Rate (ORR) and the disease control rate (DCR) based on the appropriate tumour specific guidelines/response criteria RECIST 1.1
Detailed description
The secondary efficacy endpoints for the Expansion Phase: • Duration of response (DoR), defined as the time from documentation of disease response to disease progression., • Time to progression (TTP), time from the first treatment day to objective disease progression; does not include deaths., • Overall survival (OS) defined as the interval between the first treatment day to death from any cause., The secondary safety endpoints for the Expansion Phase are as follows: • Vital signs • Physical examination • Hematology • Biochemistry • Urinalysis • Electrocardiograms (ECG) • All grades AEs and SAEs
Interventions
Sponsors
Idp Discovery Pharma S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Escalation (Phase 1) Primary Endpoint(s): • Maximum tolerated dose (MTD): based on the incidence of DLTs observed at the end of Cycle 1 (21 days). • Recommended phase 2 dose (RP2D): dose selected for the use in the expansion phase. The RP2D will be determined in discussion with the Investigators and the Sponsor based on safety (dose limiting toxicity), PK, PD, and efficacy observed across multiple dose-escalation cohorts., Expansion-Phase (Phase 2) Primary Endpoint: The primary endpoint for the Expansion-Phase is the Overall Response Rate (ORR) and the disease control rate (DCR) based on the appropriate tumour specific guidelines/response criteria RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints for the Expansion Phase: • Duration of response (DoR), defined as the time from documentation of disease response to disease progression., • Time to progression (TTP), time from the first treatment day to objective disease progression; does not include deaths., • Overall survival (OS) defined as the interval between the first treatment day to death from any cause., The secondary safety endpoints for the Expansion Phase are as follows: • Vital signs • Physical examination • Hematology • Biochemistry • Urinalysis • Electrocardiograms (ECG) • All grades AEs and SAEs | — |
Countries
Spain
Outcome results
None listed