Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Al… (NCT04484142) | Clinical Trial Compass
CompletedPhase 2
Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
United States137 participantsStarted 2021-03-30
Plain-language summary
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
✓. Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
✓. Has been treated with at least one but no more than two cytotoxic agent-containing therapy in the metastatic setting:
✓. May have received up to one checkpoint inhibitor (CPI)-containing regimen (may be in combination with a cytotoxic agent as part of a regimen described above or as an additional CPI regimen without a cytotoxic agent).
✓. Has been treated with 1 or more lines of non-CPI targeted therapy that is locally approved for the participant's applicable genomic alteration at the time of screening:
Exclusion criteria
✕. Any chemotherapeutic agent targeting topoisomerase I, including antibody drug conjugate (ADC) containing such agent.
✕. TROP2-targeted therapy.
✕. History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
✕. History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
✕. Symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) at screening. Participants with a history of Class II to IV CHF prior to screening must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days of Cycle 1 Day 1) in order to be eligible.
What they're measuring
1
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
Timeframe: From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.