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Small Cell Lung CancerPhase 3NCT07365241

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

A Phase 3 study testing ABBV-706, Topotecan and Lurbinectedin in people with Small Cell Lung Cancer, run by AbbVie at 72 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
ABBV-706, Topotecan and Lurbinectedin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
531 participants
Where
72 sitesin 10 countries
Study dates
2 Jul 2026to Sep 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

72 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

72 sites in 10 countries

United States37 sites, 37 recruiting

  • St. Lukes University Hospital /ID# 280204

    Bethlehem, Pennsylvania, 18015

    Recruiting

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

    Birmingham, Alabama, 35243

    Recruiting

  • Blue Ridge Cancer Care - Blacksburg /ID# 281583

    Blacksburg, Virginia, 24060

    Recruiting

  • Dana-Farber Cancer Institute /ID# 279690

    Boston, Massachusetts, 02215

    Recruiting

  • University of Chicago Medical Center /ID# 280149

    Chicago, Illinois, 60637

    Recruiting

  • City of Hope National Medical Center /ID# 281322

    Duarte, California, 91010

    Recruiting

  • Minnesota Oncology - Edina Clinic /ID# 280698

    Edina, Minnesota, 55435

    Recruiting

  • Willamette Valley Cancer Institute and Research Center /ID# 280617

    Eugene, Oregon, 97401

    Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 280710

    Fairfax, Virginia, 22031

    Recruiting

  • Oncology Hematology Care - Fairfield /ID# 280641

    Fairfield, Ohio, 45014

    Recruiting

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

    Fort Myers, Florida, 33901

    Recruiting

  • City Of Hope - Phoenix /ID# 281323

    Goodyear, Arizona, 85338

    Recruiting

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

    Grand Rapids, Michigan, 49503

    Recruiting

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

    Houston, Texas, 77030

    Recruiting

  • Franciscan St. Francis Health /ID# 279788

    Indianapolis, Indiana, 46237

    Recruiting

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

    Irvine, California, 92618

    Recruiting

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

    Knoxville, Tennessee, 37909

    Recruiting

  • University Of Tennessee Medical Center /ID# 279896

    Knoxville, Tennessee, 37920

    Recruiting

  • Baptist Health Louisville /ID# 280025

    Louisville, Kentucky, 40207

    Recruiting

  • University of Wisconsin /ID# 279909

    Madison, Wisconsin, 53792-0001

    Recruiting

  • Baptist Memorial Hospital /ID# 281405

    Memphis, Tennessee, 38120

    Recruiting

  • Usa Mitchell Cancer Institute /ID# 280198

    Mobile, Alabama, 36604

    Recruiting

  • West Virginia University Hospitals /ID# 279883

    Morgantown, West Virginia, 26506

    Recruiting

  • Inspira Medical Center Mullica Hill /ID# 280574

    Mullica Hill, New Jersey, 08062

    Recruiting

  • SCRI Oncology Partners /ID# 279779

    Nashville, Tennessee, 37203

    Recruiting

  • Vanderbilt University Medical Center /ID# 280169

    Nashville, Tennessee, 37232

    Recruiting

  • City Of Hope - Atlanta /ID# 279929

    Newnan, Georgia, 30265

    Recruiting

  • Orlando Health Cancer Institute /ID# 280418

    Orlando, Florida, 32806

    Recruiting

  • OSF St. Francis Medical Center /ID# 279930

    Peoria, Illinois, 61637-0001

    Recruiting

  • FirstHealth of the Carolinas- Speciality Center /ID# 279857

    Pinehurst, North Carolina, 28374

    Recruiting

  • Oregon Health and Science University /ID# 280071

    Portland, Oregon, 97239

    Recruiting

  • Mayo Clinic Hospital Rochester /ID# 279784

    Rochester, Minnesota, 55905

    Recruiting

  • Springfield Clinic - First /ID# 281309

    Springfield, Illinois, 62702

    Recruiting

  • Moffitt Cancer Center /ID# 279732

    Tampa, Florida, 33612

    Recruiting

  • Texas Oncology - Northeast Texas /ID# 280642

    Tyler, Texas, 75702

    Recruiting

  • Shenandoah Oncology /ID# 280699

    Winchester, Virginia, 22601

    Recruiting

  • City Of Hope - Chicago /ID# 281335

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

Japan17 sites, 17 recruiting

  • Juntendo University Hospital /ID# 280095

    Bunkyo-ku, Tokyo, 113-8431

    Recruiting

  • Nippon Medical School Hospital /ID# 280687

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • Kyushu University Hospital /ID# 279964

    Fukuoka, Fukuoka, 812-8582

    Recruiting

  • Saitama Medical University International Medical Center /ID# 279962

    Hidaka, Saitama, 350-1298

    Recruiting

  • Kansai Medical University Hospital /ID# 279925

    Hirakata-shi, Osaka, 573-1191

    Recruiting

  • Hirosaki University Hospital /ID# 279926

    Hirosaki, Aomori, 036-8563

    Recruiting

  • Kobe University Hospital /ID# 280290

    Kobe, Hyōgo, 650-0017

    Recruiting

  • Niigata University Medical and Dental Hospital /ID# 280027

    Niigata, Niigata, 951-8520

    Recruiting

  • Okayama University Hospital /ID# 280023

    Okayama, Okayama-ken, 700-8558

    Recruiting

  • Osaka International Cancer Institute /ID# 280026

    Osaka, Osaka, 5418567

    Recruiting

  • Kitasato University Hospital /ID# 280033

    Sagamihara-shi, Kanagawa, 252-0375

    Recruiting

  • Kindai University Hospital /ID# 280034

    Sakai-shi, Osaka, 590-0197

    Recruiting

  • Hokkaido Cancer Center /ID# 280024

    Sapporo, Hokkaido, 003-0804

    Recruiting

  • Sendai Kousei Hospital /ID# 279790

    Sendai, Miyagi, 981-0914

    Recruiting

  • Shizuoka Cancer Center /ID# 279924

    Sunto-gun, Shizuoka, 411-8777

    Recruiting

  • Teikyo University Hospital /ID# 280307

    Tokyo, 173-8605

    Recruiting

  • Fujita Health University Hospital /ID# 279969

    Toyoake, Aichi-ken, 470-1192

    Recruiting

Other trials in Japan

Germany4 sites, 4 recruiting

  • Universitaetsklinikum Koeln /ID# 280867

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • Klinikum Koeln-Merheim /ID# 280958

    Cologne, North Rhine-Westphalia, 51109

    Recruiting

  • Klinikum Kassel /ID# 280427

    Kassel, Hesse, 34125

    Recruiting

  • Universtaetsklinikum Wuerzburg /ID# 280834

    Würzburg, Bavaria, 97078

    Recruiting

Other trials in Germany

Switzerland4 sites, 4 recruiting

  • University Hospital Basel /ID# 280787

    Basel Town, Canton of Basel-City, 4031

    Recruiting

  • Hopitaux Universitaires de Geneve /ID# 280748

    Geneva, Canton of Geneva, 1205

    Recruiting

  • Centre Hospitalier Universitaire Vaudois /ID# 280847

    Lausanne, Canton of Vaud, 1011

    Recruiting

  • EOC Ospedale Regionale Lugano /ID# 280583

    Lugano, Canton Ticino, 6900

    Recruiting

Other trials in Switzerland

Greece3 sites, 3 recruiting

  • Henry Dunnant Hospital Center /ID# 280369

    Athens, Attica, 11526

    Recruiting

  • Metropolitan Hospital /ID# 280359

    Piraeus, Attica, 18547

    Recruiting

  • Interbalkan Medical Center Of Thessaloniki /ID# 280361

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

Austria2 sites, 2 recruiting

  • Universitaetsklinikum Krems /ID# 280608

    Krems, Lower Austria, 3500

    Recruiting

  • Ordensklinikum Linz Elisabethinen /ID# 281314

    Linz, Upper Austria, 4010

    Recruiting

Other trials in Austria

Spain2 sites, 2 recruiting

  • Hospital Clinic de Barcelona /ID# 281271

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Ramon y Cajal /ID# 280888

    Madrid, 28034

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • AZ-Delta. /ID# 280341

    Roeselare, West-Vlaanderen, 8800

    Recruiting

Other trials in Belgium

Brazil1 site, 1 recruiting

  • Hospital Sirio Libanes - Sao Paulo /ID# 279948

    São Paulo, 01308-050

    Recruiting

Other trials in Brazil

France1 site, 1 recruiting

  • Assistance Publique Hopitaux de Marseille - Hopital Nord /ID# 280600

    Marseille, Bouches-du-Rhone, 13915

    Recruiting

Other trials in France

About this study

Official title: A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)

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.

Read more

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.

Being tested
ABBV-706, Topotecan, Lurbinectedin, Amrubicin
Keywords
Small Cell Lung Cancer, SCLC, ABBV-706, Topotecan, Lurbinectedin, Amrubicin, Cancer
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-706Drug

    Intravenous (IV) Infusion

  • TopotecanDrug

    IV Infusion

  • TopotecanDrug

    Oral

  • LurbinectedinDrug

    IV Infusion

  • AmrubicinDrug

    IV Infusion

Study groups in NCT07365241
Study groupRoleWhat they receive
ABBV-706ExperimentalParticipants will receive ABBV-706 as part of the 53 month study duration.
Receives: Drug: ABBV-706
Stand of Care (SOC)Active comparatorParticipants will receive SOC (topotecan, lurbinectedin, and amrubicin) as part of the 53 month study duration.
Receives: Drug: Topotecan; Drug: Lurbinectedin; Drug: Amrubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to approximately 24 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 28 months

Secondary outcomes (5)

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

    PFS is defined as the time from the date of randomization to the first documentation of radiographic disease progression per RECIST v1.1 based on BICR assessment or death from any cause, whichever occurs first.

    Measured: Up to Approximately 24 Months

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

    DoR is defined as the time from the initial response of confirmed CR or PR per RECIST v1.1 based on BICR assessment to radiographic disease progression per RECIST v1.1 based on BICR assessment, or death of any cause, whichever occurs first.

    Measured: Up to Approximately 24 Months

  3. 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).

    Health-related quality-of-life (HRQoL) and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status (GHS)/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Week 12

  4. 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

    Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).

    Measured: Week 12

  5. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 53 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start2 Jul 2026
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
531 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365241
Sponsor's protocol ID
M23-384
Other IDs
2025-523819-11, 2025
Status last verified
Sep 2026
First submitted
22 Jan 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABBV-706, Topotecan and Lurbinectedin in people with Small Cell Lung Cancer, run by AbbVie at 72 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Japan, Germany, Switzerland, Greece and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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Clinical Trial NCT07365241 | AzTrials