A Phase 2 interventional study of ABBV-706 and Atezolizumab in Small Cell Lung Cancer, sponsored by AbbVie. Recruiting at 68 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by AbbVie · Phase 2, Interventional, and 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, 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.
Exclusion Criteria:
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Drug: ABBV-706 · Drug: Atezolizumab
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Drug: ABBV-706 · Drug: Atezolizumab
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Drug: Atezolizumab · Drug: Etoposide · Drug: Carboplatin · Drug: Lurbinectedin
Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Drug: ABBV-706 · Drug: Atezolizumab
Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.
Drug: ABBV-706 · Drug: Atezolizumab
Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.
Drug: Atezolizumab · Drug: Etoposide · Drug: Carboplatin · Drug: Lurbinectedin
Intravenous (IV) Infusion
IV Infusion
IV Infusion
IV Injection
IV Infusion
IV Infusion
Number of Participants with Adverse Events (AE)s
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.
Time frame: Up to 69.5 Months
Progression-Free Survival (PFS) Based on Investigator Assessment
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.
Time frame: Up to Approximately 24 Months
Overall Response (OR) as Measured by Overall Response Rate (ORR) Based on Investigator Assessment
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).
Time frame: Up to Approximately 24 Months
Duration of Response (DoR) Based on Investigator Assessment
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.
Time frame: Up to Approximately 24 Months
Disease Control (DC) Based on Investigator Assessment
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.
Time frame: Up to Approximately 24 Months
OS
OS, is defined as the time from randomization to death from any cause.
Time frame: Up to Approximately 28 Months
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap
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