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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABBV-706, Topotecan, Topotecan, Lurbinectedin.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Greece, Japan +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Interventions
- Drug ABBV-706
Intravenous (IV) Infusion - Drug Topotecan
IV Infusion - Drug Topotecan
Oral - Drug Lurbinectedin
IV Infusion - Drug Amrubicin
IV Infusion
Primary outcome measures
- Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) [Time frame: Up to approximately 24 months]
- Overall Survival (OS) [Time frame: Up to approximately 28 months]
Secondary outcome measures (5)
- Progression-free survival (PFS) based on BICR assessment per RECIST v1.1. [Time frame: Up to Approximately 24 Months]
- Duration of response (DoR) based on BICR assessment per RECIST v1.1. [Time frame: Up to Approximately 24 Months]
- Change from baseline at Week 12 in physical functioning as measured by the physical functioning domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). [Time frame: Week 12]
- Change from baseline at Week 12 in Global Health Status (GHS)/Quality of life (QoL) as measured by the EORTC QLQ-C30 GHS/QoL scale [Time frame: Week 12]
- Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately 53 Months]
Eligibility criteria
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
- 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.
- Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063 — Birmingham
- Usa Mitchell Cancer Institute /ID# 280198 — Mobile
- City Of Hope - Phoenix /ID# 281323 — Goodyear
- City of Hope National Medical Center /ID# 281322 — Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396 — Irvine
- Orlando Health Cancer Institute /ID# 280418 — Orlando
- City Of Hope - Atlanta /ID# 279929 — Newnan
- OSF St. Francis Medical Center /ID# 279930 — Peoria
- … and 18 more centers
Japan · 15 centers
- Fujita Health University Hospital /ID# 279969 — Toyoake
- Hirosaki University Hospital /ID# 279926 — Hirosaki
- Kyushu University Hospital /ID# 279964 — Fukuoka
- Hokkaido Cancer Center /ID# 280024 — Sapporo
- Kobe University Hospital /ID# 280290 — Kobe
- Kitasato University Hospital /ID# 280033 — Sagamihara-shi
- Sendai Kousei Hospital /ID# 279790 — Sendai
- Niigata University Medical and Dental Hospital /ID# 280027 — Niigata
- … and 7 more centers
Belgium · 1 center
- Universitair Ziekenhuis Antwerpen /ID# 280358 — Edegem
France · 1 center
- Centre Hospitalier Universitaire de Bordeaux /ID# 282337 — Pessac
Greece · 1 center
- Metropolitan Hospital /ID# 280359 — Piraeus
Switzerland · 1 center
- Hopitaux Universitaires de Geneve /ID# 280748 — Geneva
Identifiers
NCT: NCT07365241 · M23-384 · 2025-523819-11