A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer

NCT07365241 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M23-3842025-523819-11
• Study Type: interventional
• Target: 531
• Locations: 5 countries
• Sites: 40

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.

Conditions

Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer; SCLC; ABBV-706; Topotecan; Lurbinectedin; Amrubicin; Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR)

  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).

  Up to approximately 24 months

• Overall Survival (OS)

  OS is defined as the time from the date of randomization to the date of death of any cause.

  Up to approximately 28 months

Secondary Outcomes (5)

• Progression-free survival (PFS) based on BICR assessment per RECIST v1.1.

  Up to Approximately 24 Months

• Duration of response (DoR) based on BICR assessment per RECIST v1.1.

  Up to Approximately 24 Months

• 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

• 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

• Number of Participants with Adverse Events (AEs)

  Up to Approximately 53 Months

Study Arms (2)

ABBV-706

EXPERIMENTAL

Participants will receive ABBV-706 as part of the 53 month study duration.

Drug: ABBV-706

Stand of Care (SOC)

ACTIVE COMPARATOR

Participants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration.

Drug: Topotecan; Drug: Lurbinectedin; Drug: Amrubicin

Interventions

ABBV-706 DRUG

Intravenous (IV) Infusion

ABBV-706

Topotecan DRUG

IV Infusion

Stand of Care (SOC)

Lurbinectedin DRUG

IV Infusion

Stand of Care (SOC)

Amrubicin DRUG

IV Infusion

Stand of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (40)

Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063

Birmingham, Alabama, 35243, United States

RECRUITING

Usa Mitchell Cancer Institute /ID# 280198

Mobile, Alabama, 36604, United States

RECRUITING

City Of Hope - Phoenix /ID# 281323

Goodyear, Arizona, 85338, United States

RECRUITING

City of Hope National Medical Center /ID# 281322

Duarte, California, 91010, United States

RECRUITING

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396

Irvine, California, 92618, United States

RECRUITING

Orlando Health Cancer Institute /ID# 280418

Orlando, Florida, 32806, United States

RECRUITING

City Of Hope - Atlanta /ID# 279929

Newnan, Georgia, 30265, United States

RECRUITING

OSF St. Francis Medical Center /ID# 279930

Peoria, Illinois, 61637-0001, United States

RECRUITING

Springfield Clinic - First /ID# 281309

Springfield, Illinois, 62702, United States

RECRUITING

City Of Hope - Chicago /ID# 281335

Zion, Illinois, 60099, United States

RECRUITING

Deaconess Midtown Hospital /ID# 282134

Evansville, Indiana, 47710, United States

NOT YET RECRUITING

Franciscan St. Francis Health /ID# 279788

Indianapolis, Indiana, 46237, United States

RECRUITING

Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279955

Grand Rapids, Michigan, 49503, United States

RECRUITING

Oncology Hematology Care - Fairfield /ID# 280641

Fairfield, Ohio, 45014, United States

RECRUITING

Willamette Valley Cancer Institute and Research Center /ID# 280617

Eugene, Oregon, 97401, United States

RECRUITING

University of Pittsburgh Medical Center - Hillman Cancer Center /ID# 283745

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 280619

Knoxville, Tennessee, 37909, United States

RECRUITING

University Of Tennessee Medical Center /ID# 279896

Knoxville, Tennessee, 37920, United States

RECRUITING

Baptist Memorial Hospital /ID# 281405

Memphis, Tennessee, 38120, United States

RECRUITING

Vanderbilt University Medical Center /ID# 280169

Nashville, Tennessee, 37232, United States

RECRUITING

Shenandoah Oncology /ID# 280699

Winchester, Virginia, 22601, United States

RECRUITING

West Virginia University Hospitals /ID# 279883

Morgantown, West Virginia, 26506, United States

RECRUITING

Universitair Ziekenhuis Antwerpen /ID# 280358

Edegem, Antwerpen, 2650, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire de Bordeaux /ID# 282337

Pessac, New Aquitaine, 33604, France

NOT YET RECRUITING

Fujita Health University Hospital /ID# 279969

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Hirosaki University Hospital /ID# 279926

Hirosaki, Aomori, 036-8563, Japan

RECRUITING

Kyushu University Hospital /ID# 279964

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

Hokkaido Cancer Center /ID# 280024

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Kobe University Hospital /ID# 280290

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Kitasato University Hospital /ID# 280033

Sagamihara-shi, Kanagawa, 252-0375, Japan

RECRUITING

Sendai Kousei Hospital /ID# 279790

Sendai, Miyagi, 981-0914, Japan

RECRUITING

Niigata University Medical and Dental Hospital /ID# 280027

Niigata, Niigata, 951-8520, Japan

RECRUITING

Kansai Medical University Hospital /ID# 279925

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Osaka International Cancer Institute /ID# 280026

Osaka, Osaka, 5418567, Japan

RECRUITING

Kindai University Hospital /ID# 280034

Sakai-shi, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center /ID# 279924

Sunto-gun, Shizuoka, 411-8777, Japan

RECRUITING

Juntendo University Hospital /ID# 280095

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Nippon Medical School Hospital /ID# 280687

Bunkyo-ku, Tokyo, 113-8603, Japan

RECRUITING

Teikyo University Hospital /ID# 280307

Tokyo, 173-8605, Japan

RECRUITING

Hopitaux Universitaires de Geneve /ID# 280748

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Neoplasms

Interventions

Topotecan; PM 01183; amrubicin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 26, 2026
• Study Start: July 2, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CH (1); JP (15); FR (1); US (22); BE (1)