ABBV-706 + Atezolizumab for Small Cell Lung Cancer

(SEZanne Trial)

Recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Disqualifiers: CNS metastases, ILD, pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with extensive-stage small cell lung cancer (SCLC), a fast-growing type of lung cancer. Researchers aim to determine if a new drug, ABBV-706, combined with atezolizumab (an immunotherapy drug), is safe and effective compared to usual treatment options. Participants will be divided into groups to receive different doses of ABBV-706 with atezolizumab or the standard care. Those diagnosed with extensive-stage SCLC who have not yet received treatment may be suitable for this study. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining ABBV-706 and atezolizumab may help treat small cell lung cancer (SCLC). In earlier studies, most patients experienced side effects, which are common with cancer treatments. Specifically, about 94.9% of patients taking atezolizumab had side effects, compared to 92.3% with other treatments. This suggests the combination is generally well-tolerated, though side effects are common.

The combination of ABBV-706 and atezolizumab has also effectively reduced cancer cells in the blood. While promising, the treatment is still under investigation. The trial aims to determine the best dose and ensure the combination's safety for patients. Overall, the treatment shows potential, but like all trials, it involves risks and benefits that must be considered. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ABBV-706 in combination with atezolizumab for small cell lung cancer because it introduces a novel approach compared to standard treatments like etoposide and carboplatin. ABBV-706 targets specific cancer cell markers, potentially offering a more precise attack on cancer cells while sparing healthy ones. This targeted mechanism could lead to better efficacy and fewer side effects than traditional chemotherapy options. Additionally, the combination with atezolizumab, an immunotherapy, may enhance the body's immune response against cancer, providing a powerful one-two punch against tumor growth.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

Research has shown that using ABBV-706 with atezolizumab may help treat small cell lung cancer (SCLC). In studies, this combination caused tumors to shrink in 96.2% of patients evaluated. It also quickly reduced cancer-related DNA and cells in the blood, indicating strong efficacy against cancer. The period during which the cancer did not worsen was about 4.9 months, which is promising for SCLC. In this trial, participants will receive either ABBV-706 at varying doses combined with atezolizumab or a standard care regimen. These early results suggest that ABBV-706 with atezolizumab could effectively manage this aggressive cancer. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with previously untreated extensive stage small cell lung cancer (ES-SCLC) who are in good physical condition (ECOG Performance Status of 0 to 1), have measurable disease, and have had a brain scan if metastases are suspected. It's not for those who don't meet these criteria.

Inclusion Criteria

I have been diagnosed with extensive stage small cell lung cancer and need first-line treatment.

I am fully active or restricted in physically strenuous activity but can do light work.

* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Participants receive intravenous ABBV-706 in 1 of 2 doses with atezolizumab, or SOC to assess safety and determine the optimal dose

Up to 24 months

Regular visits at a hospital or clinic

Expansion

Participants receive intravenous ABBV-706 in 1 of 2 doses with atezolizumab, or SOC until the optimal dose is determined

Up to 24 months

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 28 months

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-706
• Atezolizumab

Trial Overview The trial is testing the safety and effectiveness of ABBV-706 combined with atezolizumab versus standard chemotherapy treatments. Participants will be randomly assigned to receive one of two doses of ABBV-706 plus atezolizumab or standard care, including etoposide, carboplatin, and optional lurbinectedin.

How Is the Trial Designed?

Group I: Safety Lead-In: Stand of Care (SOC) Experimental Treatment 4 Interventions

Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.

Group II: Safety Lead-In: ABBV-706 Dose B Experimental Treatment 2 Interventions

Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.

Group III: Safety Lead-In: ABBV-706 Dose A Experimental Treatment 2 Interventions

Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.

Group IV: Expansion: SOC Experimental Treatment 4 Interventions

Participants will receive SOC (etoposide, carboplatin, atezolizumab, and optional lurbinectedin), as part of the approximately 69.5 month study duration.

Group V: Expansion: ABBV-706 Dose B Experimental Treatment 2 Interventions

Participants will receive ABBV-706 dose B in combination with atezolizumab, as part of the approximately 69.5 month study duration.

Group VI: Expansion: ABBV-706 Dose A Experimental Treatment 2 Interventions

Participants will receive ABBV-706 dose A in combination with atezolizumab, as part of the approximately 69.5 month study duration.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07155174

NCT07155174 | A Study to Evaluate the Optimal Dose ... 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 ...

2. onclive.com onclive.com/view/advances-with-checkpoint-inhibitors-t-cell-engagers-and-adcs-converge-to-reshape-the-sclc-treatment-paradigm

Advances With Checkpoint Inhibitors, T-Cell Engagers, and ... The median PFS was 4.9 months (95% CI, 4.2-5.5), with 3-, 6-, and 9-month PFS rates of 68.0% (95% CI, 59.4%-75.2%), 35.3% (95% CI, 27.3%-43.4%), ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2025-08129

A Study to Evaluate the Optimal Dose, Adverse Events and ... 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) ...

4. news.abbvie.com news.abbvie.com/2025-10-13-AbbVie-to-Present-New-Data-at-ESMO-2025-Reinforcing-Leadership-in-Advancing-Targeted-Therapies-for-Solid-Tumors

AbbVie to Present New Data at ESMO 2025 Reinforcing ... In the same trial, ABBV-706 treatment also resulted in rapid clearance of circulating tumor DNA (ctDNA) and circulating tumor cells (CTC).

5. targetedonc.com targetedonc.com/view/immunotherapy-instills-renewed-promise-in-sclc

Immunotherapy Instills Renewed Promise in SCLC Data presented during this year's ASCO annual meeting showed tumor shrinkage occurring in 96.2% of patients ( 50 of 52) with evaluable targeted ...