Recruiting
Phase 3

ABBV-706 vs. SOC

Sponsor:

AbbVie

Code:

NCT07365241

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABBV-706

Topotecan

Topotecan

Lurbinectedin

Amrubicin

Study Details

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

Study ID

NCT07365241

Start date

Jul 2, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2030

Anticipated

Primary completion date

Sep, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

531 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-706

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

active comparator: Stand of Care (SOC)

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

Interventions

ABBV-706

Intravenous (IV) Infusion

Topotecan

IV Infusion

Topotecan

Oral

Lurbinectedin

IV Infusion

Amrubicin

IV Infusion

Primary outcome measure

  • Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 24 months ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 28 months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

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

Recruiting

Birmingham, Alabama, United States, 35243

Usa Mitchell Cancer Institute /ID# 280198

Recruiting

Mobile, Alabama, United States, 36604

City Of Hope - Phoenix /ID# 281323

Recruiting

Goodyear, Arizona, United States, 85338

City of Hope National Medical Center /ID# 281322

Recruiting

Duarte, California, United States, 91010

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

Recruiting

Irvine, California, United States, 92618

Florida Cancer Specialists & Research Institute - South /ID# 281387

Recruiting

Fort Myers, Florida, United States, 33901

Orlando Health Cancer Institute /ID# 280418

Recruiting

Orlando, Florida, United States, 32806

Moffitt Cancer Center /ID# 279732

Recruiting

Tampa, Florida, United States, 33612

City Of Hope - Atlanta /ID# 279929

Recruiting

Newnan, Georgia, United States, 30265

University of Chicago Medical Center /ID# 280149

Recruiting

Chicago, Illinois, United States, 60637

OSF St. Francis Medical Center /ID# 279930

Recruiting

Peoria, Illinois, United States, 61637-0001

Springfield Clinic - First /ID# 281309

Recruiting

Springfield, Illinois, United States, 62702

City Of Hope - Chicago /ID# 281335

Recruiting

Zion, Illinois, United States, 60099

Franciscan St. Francis Health /ID# 279788

Recruiting

Indianapolis, Indiana, United States, 46237

Baptist Health Louisville /ID# 280025

Recruiting

Louisville, Kentucky, United States, 40207

Dana-Farber Cancer Institute /ID# 279690

Recruiting

Boston, Massachusetts, United States, 02215

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

Recruiting

Grand Rapids, Michigan, United States, 49503

Minnesota Oncology - Edina Clinic /ID# 280698

Recruiting

Edina, Minnesota, United States, 55435

Mayo Clinic Hospital Rochester /ID# 279784

Recruiting

Rochester, Minnesota, United States, 55905

Inspira Medical Center Mullica Hill /ID# 280574

Recruiting

Mullica Hill, New Jersey, United States, 08062

FirstHealth of the Carolinas- Speciality Center /ID# 279857

Recruiting

Pinehurst, North Carolina, United States, 28374

Oncology Hematology Care - Fairfield /ID# 280641

Recruiting

Fairfield, Ohio, United States, 45014

Willamette Valley Cancer Institute and Research Center /ID# 280617

Recruiting

Eugene, Oregon, United States, 97401

Oregon Health and Science University /ID# 280071

Recruiting

Portland, Oregon, United States, 97239

St. Lukes University Hospital /ID# 280204

Recruiting

Bethlehem, Pennsylvania, United States, 18015

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

Recruiting

Knoxville, Tennessee, United States, 37909

University Of Tennessee Medical Center /ID# 279896

Recruiting

Knoxville, Tennessee, United States, 37920

Baptist Memorial Hospital /ID# 281405

Recruiting

Memphis, Tennessee, United States, 38120

SCRI Oncology Partners /ID# 279779

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center /ID# 280169

Recruiting

Nashville, Tennessee, United States, 37232

The University of Texas MD Anderson Cancer Center /ID# 280070

Recruiting

Houston, Texas, United States, 77030

Texas Oncology - Northeast Texas /ID# 280642

Recruiting

Tyler, Texas, United States, 75702

Blue Ridge Cancer Care - Blacksburg /ID# 281583

Recruiting

Blacksburg, Virginia, United States, 24060

Virginia Cancer Specialists - Fairfax /ID# 280710

Recruiting

Fairfax, Virginia, United States, 22031

Shenandoah Oncology /ID# 280699

Recruiting

Winchester, Virginia, United States, 22601

West Virginia University Hospitals /ID# 279883

Recruiting

Morgantown, West Virginia, United States, 26506

University of Wisconsin /ID# 279909

Recruiting

Madison, Wisconsin, United States, 53792-0001

More Information

Sponsor

AbbVie

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.