ClinicalTrials.gg
RecruitingNCT07365241Updated Sep 23, 2026

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 interventional study of ABBV-706 and Topotecan in Small Cell Lung Cancer, sponsored by AbbVie. Recruiting at 72 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by AbbVie · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
531
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Small Cell Lung Carcinoma by AbbVie — 2 open to participants now, 3 under way, 1 of them phase 3. Small Cell Lung Carcinoma · AbbVie.

Planned enrollment
2nd of 23
531 · median 132
Started
2026
the only one that year
Phase 3
4 of 25
1 open now
Registered
25th of 25
by date

Among the 25 studies in Small Cell Lung Carcinoma by AbbVie, this one is the 2nd largest by planned enrollment of the 23 interventional ones that give a count, is the only one that started in 2026, is one of 4 in phase 3, and was the 25th registered.

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.

Browse Small Cell Lung Carcinoma studies →

Open to participants now

2 of the 25 studies in Small Cell Lung Carcinoma by AbbVie are open now, in 12 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 263 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Small Cell Lung Carcinoma by AbbVie, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Small Cell Lung Cancer

Keywords

  • Small Cell Lung Cancer
  • SCLC
  • ABBV-706
  • Topotecan
  • Lurbinectedin
  • Amrubicin
  • Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of or cytologically confirmed (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 (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
  • Participants must have per (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Participants with from an extracranial solid tumor are eligible if the brain metastases are:

    • Previously treated and not requiring anticonvulsants and 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

Exclusion Criteria:

  • Participants with known active/symptomatic central nervous system .
  • Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic , or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
  • Participants with any conditions that would adversely affect the participation in the study, and the subject should have a 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 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
531 participants (estimated)

Study arms

  • Experimental
    ABBV-706

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

    Drug: ABBV-706

  • Active comparator
    Stand of Care (SOC)

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

    Drug: Topotecan · Drug: Lurbinectedin · Drug: Amrubicin

Interventions

06

What researchers measure

Primary outcomes

  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).

    Time frame: 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.

    Time frame: Up to approximately 28 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: Up to Approximately 53 Months

07

Study locations

72 of 72 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

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/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Sep 2030, 50 months after the start.

Of 55 industry-sponsored phase 3 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 44. This study's planned 50 months is above that.

Counting every sponsor, half of 68 studies reached it within 41 months; a quarter within 31 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2026
First posted
Jan 26, 2026
StartActual
Jul 2, 2026
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07365241
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Jul 2, 2026
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Sep 23, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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