| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03061812 | Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE) | PHASE3 | COMPLETED | 444 | — | — | Apr 11, 2017 | Feb 12, 2020 | Feb 23, 2021 | 195 | United States, Australia +31 |
| NCT02674568 | Study of Rovalpituzumab Tesirine (SC16LD6.5) for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer | PHASE2 | COMPLETED | 342 | — | — | Jan 25, 2016 | Oct 19, 2018 | Jul 30, 2021 | - | — |
| NCT03086239 | A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer | PHASE1 | COMPLETED | 29 | — | — | Apr 28, 2017 | Aug 20, 2018 | Aug 3, 2021 | 5 | Japan |
OS is defined as the time from the date of randomization to the date of death from any cause. Participants were censored at the last date they were documented alive. After the End of treatment, survival information was collected at approximately 6-week intervals (or as requested by sponsor to support data analysis) continuing until the endpoint of death, the participant became lost to follow-up, AbbVie terminated the study, or until 12 February 2020. Calculated using the Kaplan-Meier product-limit method.
Objective response is defined as a participant with the best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, prior to receiving any subsequent anticancer therapy and retreatment, and is confirmed by a consecutive response assessment at least 4 weeks (28 days) from the initial determination of CR/PR. Analyzed based on response assessments from both the Independent Review Committee (IRC) and investigators. CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall survival is defined as the time from the first dose date to death for any reason. Participants who were alive at the clinical data cut-off were censored at the last known alive date. Based on Kaplan-Meier estimates.
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
| Arm | Type | Description |
|---|---|---|
| Rovalpituzumab tesirine | EXPERIMENTAL | Rovalpituzumab tesirine IV administration (dosing based on actual body weight) on Day 1 of a 42-day cycle for 2 cycles, with up to 2 additional cycles permitted. Dexamethasone coadministered orally (PO) twice daily at a dose of 8 mg on Day -1, Day 1, and Day 2 of each 42-day cycle in which rovalpituzumab tesirine is administered. |
| Topotecan | ACTIVE_COMPARATOR | Topotecan given as an intravenous (IV) infusion over 30 minutes at a dose of 1.5 mg/m\^2 on Days 1 to 5 of each 21-day cycle. |
| Part A: Rovalpituzumab tesirine | EXPERIMENTAL | Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle |
| Part B: Rovalpituzumab tesirine | EXPERIMENTAL | Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD). |
| Name | Type | Description |
|---|---|---|
| Rovalpituzumab tesirine | DRUG | Powder for solution for infusion in vials. |
| Topotecan | DRUG | Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region. |
| Dexamethasone | DRUG | Oral tablet. |
Inclusion Criteria: * Participant must have histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen * Tumor must have high Delta-like protein 3 (DLL3) expr...