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A Study of ABBV-706 to Assess Safety and Efficacy Compared with Standard Drug Combination in Adults with Relapsed or Refractory Small Cell Lung Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Small Cell Lung Cancer, a fast‑growing type of lung cancer that often returns after initial treatment. It compares a new intravenous medicine called ABBV-706 with the usual chemotherapy options, which may include topotecan, lurbinectedin or amrubicin. The purpose of the study is to find out whether the new drug can improve how well the cancer responds and help patients live longer.

Participants are assigned to receive either the new drug or one of the standard medicines, given by infusion or pill in repeated cycles over several months. Throughout the study, patients have regular doctor visits, blood tests, and imaging scans to check the size of the tumors and overall health.

The main results the researchers will look at are the objective response (how much the tumors shrink), the overall survival (how long patients live after starting treatment), the progression‑free survival (time before the cancer gets worse), and the duration of response (how long the shrinkage lasts). Tumor measurements follow the RECIST guidelines and are reviewed by an independent team called BICR to keep the assessment unbiased. Patients also complete a questionnaire known as the EORTC QLQ-C30 that asks about physical functioning and overall quality of life at different times during the trial.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study you will have a series of initial tests. these may include a physical exam, blood tests, and imaging scans to document the current status of your small cell lung cancer.

    The information collected will be used to compare future changes while you are receiving study treatment.

  2. Step 2

    Random assignment to treatment

    Based on the information from the baseline assessments you will be placed into one of two groups. one group receives the investigational drug abbv-706, the other group receives a standard‑of‑care medicine such as topotecan (which can be given by mouth or through a vein).

    The assignment is done by the study system and you will not know which group you are in.

  3. Step 3

    Receive study medication

    If you are assigned to the investigational arm you will receive abbv-706 as an intravenous infusion. the dose listed in the study documents is 00 mg, and the exact amount and schedule will be determined by the study doctors.

    If you are assigned to the standard‑of‑care arm you will receive topotecan. this drug may be taken as an oral tablet or given as an intravenous infusion, also listed at a dose of 00 mg. the frequency and length of treatment follow the study protocol and will be explained by the study team.

  4. Step 4

    Regular follow‑up visits and assessments

    Throughout the treatment period you will return to the clinic for scheduled visits. during each visit blood tests and other safety checks will be performed.

    Imaging scans will be repeated at intervals to evaluate tumor response. a specific assessment is performed at week 12 to measure changes in physical functioning and overall quality of life using questionnaires.

  5. Step 5

    Monitoring for side effects

    At every visit you will be asked about any new symptoms or side effects. the study staff will record these events and may adjust the medication schedule if needed.

    Common terms such as "adverse event" refer to any unwanted health change that occurs while you are receiving the study drug.

  6. Step 6

    Treatment completion and final evaluation

    Treatment will continue until the study protocol defines an end point, such as disease progression, unacceptable side effects, or the planned study duration.

    After the last dose you will have a final set of assessments to determine overall response, survival outcome, and any lasting effects of the medication.

Who can join the trial?

7 criteria

  • Have a confirmed diagnosis of **relapsed or refractory small cell lung cancer** (the cancer has returned after treatment or does not respond to treatment), proven by looking at tissue samples under a microscope.
  • Be able to receive the standard chemotherapy medicines used in this disease, which may include **topotecan, lurbinectedin, or amrubicin**.
  • Have an **ECOG Performance Status** of 0 or 1, meaning you are fully active (0) or able to carry out light work (1) during the screening period.
  • Have disease that can be measured on scans according to **RECIST v1.1** (a set of rules for measuring tumor size), including any previously treated areas that show tumor growth.
  • Have already received earlier treatments such as platinum‑based chemotherapy (drugs like carboplatin or cisplatin combined with etoposide) and a drug called **tarlatamab**, with or without a **checkpoint inhibitor (CPI)** if you were eligible.
  • If you have cancer that has spread to the brain, you can still join if the brain tumors are either:
    • Previously treated and you have not needed seizure medicines (anticonvulsants) or steroids for at least 7 days before the study drug, or you are taking a low dose of steroids (prednisone ≤ 10 mg per day); or
    • Untreated, not causing symptoms, and you have not needed anticonvulsants or steroids for at least 7 days before the study drug, or you are on a low dose of steroids (prednisone ≤ 10 mg per day).

Who cannot join the trial?

5 criteria

  • People who have active or symptomatic central nervous system metastases – meaning cancer that has spread to the brain or spinal cord and is causing symptoms.
  • People who have ever had interstitial lung disease (ILD) or pneumonitis that needed treatment with strong medicines called steroids, or who show any current signs of ILD or pneumonitis on a chest CT scan (a detailed X‑ray of the lungs).
  • People with any other serious health problems that could make the study unsafe for them, and who are not expected to live at least three more months (life expectancy of at least 3 months).
  • People who have already received a drug called a seizure-related 6 homolog (SEZ6) targeted antibody drug conjugate (ADC), any other targeted ADC, or any other experimental medication (except tarlatamab) as their first treatment (first‑line) for cancer.
  • People who have already been treated with any Top1i drug – these are medicines that block an enzyme called topoisomerase I, such as topotecan, irinotecan, belotecan, camptothecin, rubitecan, exatecan, or any similar locally approved drug.
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Investigated drugs

  • ABBV-706

    is an investigational medicine being tested in this study. It is a laboratory‑made antibody that is designed to find and attach to a protein called SEZ6 on cancer cells. By binding to this protein, the antibody may help the immune system recognize and attack the tumor. The drug is given through an IV infusion, meaning it is delivered directly into a vein over a short period. Researchers are studying whether ABBV-706 works better than usual chemotherapy for people whose small cell lung cancer has come back or did not respond to earlier treatment.

  • TOPOTECAN

    is a chemotherapy drug that is part of the standard treatment options for small cell lung cancer. It works by interfering with the DNA inside cancer cells, which stops the cells from growing and causes them to die. In this trial, topotecan may be given either as a pill you swallow (oral) or as an IV infusion, depending on the doctor's decision. It is used as the comparison (comparator) to see if the new drug, ABBV-706, can provide better results for patients.

What is already known about the treatment

  • TOPOTECAN

    Topotecan is given either as an oral tablet or by intravenous infusion, allowing it to enter the bloodstream directly. It is an approved chemotherapy drug that has been used for many years to treat small cell lung cancer and other cancers such as ovarian cancer. The medicine works by blocking an enzyme called topoisomerase I, which stops cancer cells from un‑winding their DNA and therefore stops them from dividing. It belongs to the class of topoisomerase inhibitors, a type of antineoplastic (anti‑cancer) agent.

  • ABBV-706

    ABBV‑706 is administered as an intravenous infusion of a clear solution. It is an experimental antibody‑drug conjugate that is currently being studied in clinical trials for relapsed or refractory small cell lung cancer. The drug combines a human IgG1 monoclonal antibody that seeks out the SEZ6 protein on tumor cells with a linked cytotoxic compound that damages the cell’s DNA once delivered. This makes ABBV‑706 a targeted therapy classified as an antibody‑drug conjugate.

Investigated diseases

Small Cell Lung Cancer - Small Cell Lung Cancer is a type of lung cancer that begins in the small, round cells lining the airways. It grows quickly and can spread to other parts of the body early in its course. As the tumor expands, it may cause coughing, shortness of breath, and chest discomfort. The disease often progresses to involve nearby lymph nodes and distant organs such as the liver, brain, and bones. Its rapid growth leads to a steady increase in tumor size and spread over a relatively short period.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523819-11-00Protocol codeM23-384Estimated enrolment531 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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