ABBV-706 / Amrubicin / Topotecan · Phase 3 Trial

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

ClinicalTrials.gov · August 14, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 trial registration for ABBV-706 in relapsed/refractory small cell lung cancer that is currently recruiting participants. No results have been posted in this registry record; the study is designed to evaluate safety, tolerability, and disease activity endpoints (ORR and OS) over approximately 53 months of follow-up.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Small Cell Lung Cancer; age from 18 Years. Intervention: ABBV-706. Compared with: Stand of Care (SOC) — Active Comparator. n = 531. 46 sites across 6 countries.

Key findings

Safety

Recruitment status is ongoing; no efficacy or safety data are available No baseline characteristics, adverse events, or outcome data are reported

Who this may help

Clinicians should monitor for publication of results from this trial comparing ABBV-706 to standard of care (topotecan, lurbinectedin, or amrubicin) in SCLC. No clinical guidance can be drawn from this registry record until results are posted.

Plain-language summary

This is an ongoing Phase 3 trial registration with no results posted; the study is actively recruiting and has not yet reported efficacy or safety outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) (assessed at Up to approximately 24 months); Overall Survival (OS) (assessed at Up to approximately 28 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationSmall Cell Lung Cancer; age from 18 Years

Sample size531

InterventionABBV-706

ComparatorStand of Care (SOC) — Active Comparator

Setting46 sites across 6 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment531

Number of sites175

Primary endpoint 1Objective Response Rate (ORR) by Blinded Independent Central Review, up to approximately 24 months

Primary endpoint 2Overall Survival (OS), up to approximately 28 months

Estimated study durationapproximately 53 months

Clinical bottom line

Caveats

No results have been reported; this is a study registration only
Recruitment status is ongoing; no efficacy or safety data are available
Specific inclusion/exclusion criteria and randomization methodology are not detailed in this registry summary
No baseline characteristics, adverse events, or outcome data are reported

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 interventional randomized design comparing ABBV-706 to standard of care

Directness

strong

Primary endpoints are clinically relevant: overall response rate and overall survival

Consistency

insufficient

No results available; consistency cannot be assessed against other trials

Risk of bias

moderate

Blinded independent central review for response assessment; no report of allocation concealment details

Sample adequacy

strong

Estimated 531 participants across 175 sites; adequate sample for Phase 3 OS/ORR endpoints

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07365241). This is a study registration, not published results. Lead sponsor: AbbVie. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 531 participants (ESTIMATED). Conditions: Small Cell Lung Cancer. Interventions: DRUG: ABBV-706; DRUG: Topotecan; DRUG: Topotecan; DRUG: Lurbinectedin; DRUG: Amrubicin. Primary outcome measures: Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) , Up to approximately 24 months; Overall Survival (OS) , Up to approximately 28 months. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ABBV-706AmrubicinTopotecanAbbvieSmall Cell Lung CancerLurbinectedinNCT07365241