Title
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy ofABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Description
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Objective
Primary:
- To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan,
lurbinectedin, or amrubicin) in terms of objective response (OR) as measured by ORR based on blinded independent central review (BICR) assessment per RECIST v1.1.
- To demonstrate the superiority of ABBV-706 versus standard of care comparator (topotecan,
lurbinectedin, or amrubicin) in terms of efficacy as measured by overall survival (OS).

Secondary:
- To assess the safety and tolerability of ABBV-706 versus standard of care comparator.
- To evaluate the efficacy of ABBV-706 versus standard of care comparator as measured by
progression-free survival (PFS) and duration of response (DoR) by BICR.
- To evaluate the impact of ABBV-706 on patient-reported physical functioning and quality of life outcomes as measured by EORTC-QLQ-C30.

Treatment Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin).

ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide.

Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC [topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)]. The estimated duration of the study is approximately 53 months.

Key Eligibility Inclusion Criteria:

- 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

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.

Applicable Disease Sites
Lung

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital