Loading
Datopotamab Deruxtecan / Brain Metastases / Pembrolizumab · Phase 2 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an actively recruiting Phase 2 single-arm trial of datopotamab deruxtecan, carboplatin, and pembrolizumab in treatment-naive NSCLC patients with brain metastases. No efficacy or safety results are yet reported; the study aims to assess intracranial objective response rate over approximately 2 years of follow-up. This represents exploratory evidence generation in a complex patient population, but the absence of a control arm and lack of completed data limit the strength of any future findings.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Lung Cancer, Non Small Cell Lung Cancer, Brain Metastases; age from 18 Years. Intervention: Single arm: pembrolizumab, datopotamab-deruxtecan, and carb…. n = 46. 13 sites: Brazil.
This is a registry record for an actively recruiting Phase 2 single-arm trial of datopotamab deruxtecan, carboplatin, and pembrolizumab in treatment-naive NSCLC patients with brain metastases. No efficacy or safety results are yet reported; the study aims to assess intracranial objective response rate over approximately 2 years of follow-up. This represents exploratory evidence generation in a complex patient population, but the absence of a control arm and lack of completed data limit the strength of any future findings.
No efficacy or safety results are reported in this registry record; study is currently recruiting.
The source did not state who this applies to in practice.
This is a recruiting Phase 2 single-arm trial with no posted results; it represents early-stage investigation of a three-drug combination for brain metastases from NSCLC.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06822543). This is a study registration, not published results. Lead sponsor: Latin American Cooperative Oncology Group. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 46 participants (ESTIMATED). Conditions: Lung Cancer, Non Small Cell Lung Cancer, Brain Metastases. Interventions: DRUG: Pembrolizumab; DRUG: Datopotamab deruxtecan; DRUG: Carboplatin. Primary outcome measures: Confirmed Intracranial Objective Response Rate (iORR) as Measured by the RANO-BM Criteria , Through study primary completion, an average of 2 years. Brief summary: This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.