A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination with Atezolizumab versus Standard of Care as First-Line Treatment in Participants with Previously Untreated Extensive Stage Small Cell Lung Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

31 Mar 2026 → ongoing

Decision date (initial)

2026-03-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2024-517490-24-00

ClinicalTrials.gov

NCT07155174

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

- To evaluate the safety and tolerability of ABBV-706 in combination with atezolizumab
- To optimize and select the recommended Phase 3 dose (RP3D) of ABBV-706 in combination with atezolizumab
- To evaluate efficacy as measured by progression-free survival (PFS) of ABBV-706 in combination with atezolizumab

Secondary objectives 2

1. To further evaluate the efficacy of ABBV-706 in combination with atezolizumab as measured by overall response rate (ORR), duration of response (DoR), disease control rate (DCR) and overall survival (OS).
2. To characterize the pharmacokinetics (PK) and immunogenicity of ABBV-706 in combination with atezolizumab

Conditions and MedDRA coding

Small Cell Lung Cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

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. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 during the screening period prior to the first dose of study treatment.
3. Participants must be considered suitable to receive a platinum-based chemotherapy or atezolizumab regimen as first line treatment for ES-SCLC. Chemotherapy must contain carboplatin in combination with etoposide.
4. 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.

Exclusion criteria 5

1. Histologically or cytologically confirmed mixed small cell lung cancer (SCLC).
2. Prior treatment of any kind for LS-SCLC.
3. Prior systemic therapy for the treatment of first line ES-SCLC.
4. Participants with known active/symptomatic central nervous system (CNS) metastases
5. Participants with a history of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-Free Survival (PFS) based on investigator assessment per RECIST v1.1.

Secondary endpoints 4

1. Overall Response (OR) as Measured by Overall Response Rate (ORR) based on investigator assessment per RECIST v1.1.
2. Duration of Response (DoR) based on investigator assessment per RECIST v1.1.
3. Disease Control (DC) based on investigator assessment per RECIST v1.1.
4. OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 7

Locations

5 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications