extensive-stage lung cancer small cell lung cancer
Conditions
Interventions
Subjects will receive one of the following treatments: 0.3 mg/kg Rova-T or
placebo IV infusion. Subjects will receive their assigned therapy on Day 1 of
each 6-week cycle, omitting every third cycle
Sponsors
AbbVie B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC at initial diagnosis) with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR] per RECIST v1.1) following completion of 4 cycles of first-line platinum-based therapy • Subject is eligble to be randomized at least 3 but no more than 9 weeks from day 1 of the fourth cycle platinum-based chemotherapy. • Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 • Participants must have adequate bone marrow, renal and hepatic function
Exclusion criteria
Exclusion criteria: • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria 3-5 for SCLC • Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing ) after last dose of first-line chemotherapy. • Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) and overall survival (OS). Timepoints of evaluation: PFS - From randomization to disease progression, or death of any cause, whichever occurs first. OS - From randomization to death of any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) based on investigator assessment - Objective response rate (ORR) per the CRAC and investigator assessment, respectively - Clinical benefit rate (CBR) per the CRAC and investigator assessment, respectively - Duration of response (DOR) per the CRAC and investigator assessment, respectively Response assessment will be based on RECIST v1.1. - Changes in patient reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (QLQ-LC13) - Safety endpoints will be summarized using data from the Safety set. Timepoints of evaluation: Disease progression will be defined as radiographic progression of disease by RECIST version 1.1. PFS, ORR, CBR, DOR - From randomization to disease progression, or death of any cause, whichever occurs first. Changes in PROs - From baseline (the assessment prior to first dose) to disease progression, or death of any cause, whichever occurs first. Safety endpoints - From baseline to specified time points throughout the study. | — |
Countries
Netherlands
Outcome results
None listed