Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer, SCLC, ABBV-706, Etoposide, Carboplatin, Atezolizumab, Lurbinectedin
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, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide. In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 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
DRUGABBV-706
Intravenous (IV) Infusion
DRUGAtezolizumab
IV Infusion
DRUGEtoposide
IV Infusion
DRUGCarboplatin
IV Injection
DRUGLurbinectedin
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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 extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy. * 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. * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.
Exclusion criteria
* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC). * Known active/symptomatic central nervous system (CNS) metastases should be excluded. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded. * Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE)s | Up to 69.5 Months | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Progression-Free Survival (PFS) Based on Investigator Assessment | Up to Approximately 24 Months | PFS is defined as the time from randomization to the first documentation of radiological progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment | 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 RECIST v1.1 as determined by investigator prior to initiation of subsequent anti-cancer therapy. OR will be summarized by ORR, defined as the proportion of subjects achieving OR and will be summarized for each arm with its associated 95% confidence interval (CI). |
| Duration of Response (DoR) Based on Investigator Assessment | Up to Approximately 24 Months | DoR is defined as time from the initial response of CR/PR until the first documentation of radiographical PD according to RECIST v1.1 by investigator or death from any cause, whichever occurs first. |
| Disease Control (DC) Based on Investigator Assessment | Up to Approximately 24 Months | DC is defined as achieving an OR or stable disease (SD) according to RECIST v1.1 by investigator at any time prior to subsequent anti-cancer therapy. |
| OS | Up to Approximately 28 Months | OS, is defined as the time from randomization to death from any cause. |
Countries
Germany, Israel, Japan, South Korea, Spain, Taiwan, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed