Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer, SCLC, ABBV-706, Topotecan, Lurbinectedin, Amrubicin, Cancer
Brief summary
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
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) | Up to approximately 24 months | OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR)/partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by BICR assessment prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the percentage of participants achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI). |
| Overall Survival (OS) | Up to approximately 28 months | OS is defined as the time from the date of randomization to the date of death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DoR) based on BICR assessment per RECIST v1.1. | Up to Approximately 24 Months | DoR is defined as the time from the initial response of confirmed CR or PR per RECIST v1.1 based on BICR assessment to radiographic disease progression per RECIST v1.1 based on BICR assessment, or death of any cause, whichever occurs first. |
| 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). | Week 12 | Health-related quality-of-life (HRQoL) and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status (GHS)/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
| 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 | Week 12 | Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
| Progression-free survival (PFS) based on BICR assessment per RECIST v1.1. | Up to Approximately 24 Months | PFS is defined as the time from the date of randomization to the first documentation of radiographic disease progression per RECIST v1.1 based on BICR assessment or death from any cause, whichever occurs first. |
| Number of Participants with Adverse Events (AEs) | Up to Approximately 53 Months | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed