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Life sciences · Phase 2 Trial
ClinicalTrials.gov · November 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04940325). This is a study registration, not published results. Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 100 participants (ACTUAL). Conditions: Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer, Unresectable Non-small Lung Cancer. Interventions: DRUG: DS-1062a. Primary outcome measures: Evaluation of objective response rate (ORR) based on investigator assessment , During treatment period, an average of 4 months. Brief summary: This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than three previous standard therapies. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated. A total of 100 participants are planned to be included in the study. Participants will receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until progression or until unacceptable toxicity. Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis. The safety of the product will be assessed, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.