ABBV-706 plus standard care for relapsed/refractory small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares intravenous ABBV-706 to the physician's choice of standard-of-care therapies (topotecan, lurbinectedin, or amrubicin) in adults with relapsed or refractory small cell lung cancer. Up to about 531 participants will be enrolled across numerous sites globally and followed for roughly five years to assess safety, tolerability, and changes in disease activity. Participants receive either ABBV-706 or SOC, with treatment continuing until disease progression, unacceptable toxicity, or other stopping rules. The study aims to determine whether ABBV-706 can provide a favorable balance of benefit and risk compared with the current SOC options. Enrollment includes patients who have previously received platinum-based therapy and other specified treatments, and ECOG performance status will be used to determine eligibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed Relapsed/Refractory (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 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Participants with brain metastasis from an extracranial solid tumor are eligible if the brain metastases are:

  * Previously treated and not requiring anticonvulsants and steroids 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:

* Participants with known active/symptomatic central nervous system metastases.
* Participants with a history of interstitial lung disease (ILD) or pneumonitis that previously required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.
* Participants with any clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy 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 investigational 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.

Where it's running

• Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063
  Birmingham, Alabama, United States Recruiting
• Usa Mitchell Cancer Institute /ID# 280198
  Mobile, Alabama, United States Recruiting
• City Of Hope - Phoenix /ID# 281323
  Goodyear, Arizona, United States Recruiting
• City of Hope National Medical Center /ID# 281322
  Duarte, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396
  Irvine, California, United States Recruiting
• Florida Cancer Specialists & Research Institute - South /ID# 281387
  Fort Myers, Florida, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cirtuvivint plus irinotecan for relapsed small-cell lung cancer

  This trial will test whether adding cirtuvivint to irinotecan helps people with relapsed small-cell lung cancer respond better and live longer.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT07155200

• Tarlatamab in strong-performance-status small-cell lung cancer

  This trial tests whether tarlatamab can help people with extensive-stage small-cell lung cancer and poor health (ECOG 2) who have already had prior treatment.

  Recruiting at 8 sites Phase 2 AIO-Studien-gGmbH · Berlin and 7 other locations · NCT07803848

• Armored DLL3-SAVVYZ-IL18 CAR T cells for DLL3+ cancers

  Aims to see if DLL3-SAVVYZ-IL18 CAR T cells can be safely given to people with DLL3-positive cancers, including certain small cell lung cancers and other neuroendocrine tumors.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07783477

• Tarlatamab given under the skin vs by IV in extensive-stage small cell lung cancer after platinum therapy

  This trial tests whether subcutaneous tarlatamab works as well as the IV form for people with extensive-stage small cell lung cancer after platinum chemotherapy.

  Recruiting at 9 sites Phase 3 Amgen · Orlando, Florida and 8 other locations · NCT07778316

• NK Cells Plus Immunotherapy for Extensive-Stage Small Cell Lung Cancer Maintenance

  This study tests whether adding allogeneic NK cell therapy to standard immunotherapy helps people with extensive-stage small cell lung cancer who have disease control after initial chemotherapy and immunotherapy.

  Recruiting Phase 2 Tianjin First Central Hospital · Tianjin, Tianjin Municipality · NCT07759856

• BL-M14D1 plus atezolizumab vs standard therapy in first-line extensive-stage small cell lung cancer

  A first-line treatment for adults with extensive-stage small cell lung cancer tests whether adding BL-M14D1 to atezolizumab and standard chemotherapy helps more than standard care.

  Recruiting at 7 sites Phase 3 SystImmune Inc. · Springdale, Arkansas and 61 other locations · NCT07625644

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.