A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (R/R) Small Cell Lung Cancer (SCLC).
Participants must have progressed on prior systemic therapy, with CPI (if eligible) and prior tarlatamab, defined as:
* In the 1L and 2L setting respectively, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI, if eligible for CPI) and 2L tarlatamab; or
* In the 1L and 2L setting, platinum-based chemotherapy (i.e., carboplatin and etoposide with atezolizumab and lurbinectedin in combination with atezolizumab maintenance and 2L tarlatamab; or
* In the 1L setting, platinum-based chemotherapy (i.e., carboplatin or cisplatin and etoposide with CPI if eligible) in combination with tarlatamab in frontline induction and/or maintenance
Participants must be considered suitable to receive SOC comparator (topotecan, lurbinectedin, or amrubicin).
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Previously treated and not requiring anticonvulsants and steroids for at least 7 days prior to first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone dose of ≤ 10 mg/day are eligible or;
* Untreated and asymptomatic not requiring anticonvulsants and steroids for at least 7 days prior to the first dose of study treatment. If required for management, subjects on a steroid equivalent of prednisone of ≤ 10 mg/day are eligible.
You may not be if
Participants with known active/symptomatic central nervous system metastases.
Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
Participants with any clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy of at least 3 months.
Participants who have received prior treatment with a seizure-related 6 homolog (SEZ6) targeted Antibody drug conjugate (ADC), other targeted ADCs, or any other investigational agent not including tarlatamab in 1L.
Participants who have received prior treatment with any Top1i such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan or locally approved topoisomerase I inhibitor (Top1i) payload.
Clareo Health | A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer
