Study on ABBV-706 Compared to Standard Treatment for Adults with Relapsed or Refractory Small Cell Lung Cancer
Sponsor: AbbVie
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
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Birmingham Hematology and Oncology Associates d/b/a Alabama Oncology /ID# 280063 | 35243 | Birmingham | Alabama |
| Usa Mitchell Cancer Institute /ID# 280198 | 36604 | Mobile | Alabama |
| City Of Hope - Phoenix /ID# 281323 | 85338 | Goodyear | Arizona |
| City of Hope National Medical Center /ID# 281322 | 91010 | Duarte | California |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 281396 | 92618 | Irvine | California |
| Orlando Health Cancer Institute /ID# 280418 | 32806 | Orlando | Florida |
| City Of Hope - Atlanta /ID# 279929 | 30265 | Newnan | Georgia |
| OSF St. Francis Medical Center /ID# 279930 | 61637-0001 | Peoria | Illinois |
| Springfield Clinic - First /ID# 281309 | 62702 | Springfield | Illinois |
| City Of Hope - Chicago /ID# 281335 | 60099 | Zion | Illinois |
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