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

Conditions

• Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ABBV-706 — DRUG
  Intravenous (IV) Infusion
• Topotecan — DRUG
  IV Infusion
• Topotecan — DRUG
  Oral
• Lurbinectedin — DRUG
  IV Infusion
• Amrubicin — DRUG
  IV Infusion

Study Details

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.

Key Dates

First listed

Jan 26, 2026

Start date

Jul 2, 2026

Status verified

Aug 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

531 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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 ]

Central Contacts

• ABBVIE CALL CENTER
  844-663-3742
  [email protected]

Locations (32)

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