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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Intercommunal Creteil Creteil France
Katholieke Universiteit te Leuven Leuven Belgium
Institut Curie – Site Paris Paris France
CHU Grenoble Alpes La Tronche France
Technische Universitaet Dresden Dresden Germany
Medizinische Universitaet Innsbruck Innsbruck Austria

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Nantes Nantes France
Cliniche Gavazzeni S.p.A. Bergamo Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Henry Dunant Hospital Center Athens Greece
Metropolitan Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Universitaetsklinikum Regensburg AöR Regensburg Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Klinikum Kassel GmbH Kassel Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Asklepios Klinik Gauting GmbH Gauting Germany
Muehlenkreiskliniken AöR Minden Germany
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Universitaetsklinikum Krems Krems An Der Donau Austria
Cfbxckpnu Uidlkkqycqxnfc Safkizxvc Woluwe-Saint-Lambert Belgium
Lwxis Gbpyvsp Hyzqxqef Og Axehlf Athens Greece
Iipaxhvk Rwzkbbley Poq Lv Ssuqwo Dmc Twcuef Dgab Aqydyxu Iiwk Sqfdbv Meldola Italy
Aknjfovper Pkotmuac Hrusoena Di Mhntflvrg Marseille France
Akahss Myixkyk Ckkruk Stiv Thessaloniki Greece
Cjddsh Lkkq Bnidej Lyon France
Griupo Htwjdszthax Ukekffuanyipm Pbfei Potwkjdlmyf Ec Nkgwshwhfukd Paris France
Aqdthfk Oplaxeupdke S Gibrihps Aeerychyyz Rome Italy
Hfkdlqrj Vzka dlnnfwfb Barcelona Spain
Umlgtsonrd Hxkffibr Cbsgkgv Cologne Germany
Urgvftukllvpuzmoqifiv Wrgrcqnuk Acr Wuerzburg Germany
Utbfavysuxtvfukpaptvm Ectij Acx Essen Germany
Onehyimdcpziua Lttw Gzjx Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.08.2026
Belgium Belgium
Not yet recruiting
01.08.2026
France France
Not yet recruiting
01.08.2026
Germany Germany
Not yet recruiting
01.08.2026
Greece Greece
Not yet recruiting
01.08.2026
Italy Italy
Not yet recruiting
01.08.2026
Spain Spain
Not yet recruiting
01.08.2026

Trial locations

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.

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 ID:
2025-523819-11-00
Protocol code:
M23-384
NCT ID:
NCT07365241
Trial Phase:
Therapeutic confirmatory (Phase III)

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