Study on ABBV-706 Compared to Standard Treatment for Adults with Relapsed or Refractory Small Cell Lung Cancer

Sponsor: AbbVie

Sponsor score: 60

ClinicalTrials ID:NCT07365241

This clinical trial is testing a new drug, ABBV-706, to see if it is safe and effective in treating adults with small cell lung cancer that has returned or not responded to previous treatments. Participants will receive either ABBV-706 or standard treatments like topotecan, lurbinectedin, or amrubicin.

Patient Parameters

Program Overview

Small cell lung cancer (SCLC) is a fast-growing cancer that often spreads early to other parts of the body, such as the liver, bones, and brain. This study aims to compare the safety and effectiveness of a new drug, ABBV-706, with standard treatments for SCLC. Participants will be randomly assigned to receive either ABBV-706 or one of the standard treatments, which include topotecan, lurbinectedin, or amrubicin. The study will involve about 531 adults from 175 locations worldwide and will last approximately 53 months. Participants will need to visit the hospital or clinic regularly for check-ups, tests, and scans.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of relapsed or refractory small cell lung cancer (SCLC).
  • Cancer must have progressed after previous treatments, including platinum-based chemotherapy and other specific drugs if eligible.
  • Must be suitable to receive standard treatments like topotecan, lurbinectedin, or amrubicin.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have measurable cancer according to specific medical criteria.
  • If there are brain metastases, they must be treated and stable, or untreated but not causing symptoms, and not requiring certain medications.

Exclusion Criteria

  • Have active or symptomatic cancer spread to the central nervous system.
  • Have a history of lung diseases like interstitial lung disease or pneumonitis that needed steroid treatment.
  • Have any serious medical conditions that could affect participation in the study.
  • Have received certain previous treatments targeting specific proteins or using investigational drugs, except for tarlatamab in initial treatment.
  • Have previously been treated with specific topoisomerase I inhibitors like topotecan or similar drugs.

Locations

FACILITYZIPCITYSTATE
Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 28006335243BirminghamAlabama
Usa Mitchell Cancer Institute /ID# 28019836604MobileAlabama
City Of Hope - Phoenix /ID# 28132385338GoodyearArizona
City of Hope National Medical Center /ID# 28132291010DuarteCalifornia
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 28139692618IrvineCalifornia
Orlando Health Cancer Institute /ID# 28041832806OrlandoFlorida
City Of Hope - Atlanta /ID# 27992930265NewnanGeorgia
OSF St. Francis Medical Center /ID# 27993061637-0001PeoriaIllinois
Springfield Clinic - First /ID# 28130962702SpringfieldIllinois
City Of Hope - Chicago /ID# 28133560099ZionIllinois

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