✓ Translated by DotMD AI Clinical Council Source: Annals of oncology : official journal of the European Society for Medical Oncology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39672382 ↗

Phase III Randomized Trial: Biomarker analyses from the phase III randomized CLEAR trial: lenvatinib plus pembrolizumab versus sunitinib in advanced renal cell carcinoma

Original Paper Title: “Biomarker analyses from the phase III randomized CLEAR trial: lenvatinib plus pembrolizumab versus sunitinib in advanced renal cell carcinoma”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Improvements in objective response rate and PFS for L + P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes.
  • Study Design & Sample: Phase III Randomized Trial published in Annals of oncology : official journal of the European Society for Medical Oncology (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Annals of oncology : official journal of the European Society for Medical Oncology (2025), this phase iii randomized trial evaluating human clinical outcomes investigated: In CLEAR, lenvatinib + pembrolizumab (L + P) significantly improved efficacy versus sunitinib in first-line treatment of patients with advanced renal cell carcinoma (aRCC). Key clinical takeaway: Improvements in objective response rate and PFS for L + P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Annals of oncology : official journal of the European Society for Medical Oncology, 2025-04-15; Phase III Randomized Trial; Rigor 82/100): Improvements in objective response rate and PFS for L + P versus sunitinib in aRCC were observed consistently across a range of biomarker subgroups defined using RCC driver mutations, PD-L1, gene expression signatures, and molecular subtypes.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: lenvatinib → Rx: sunitinib-malate → Rx: advanced-eye-relief-eye-wash-water-solution → Condition: malignant-neoplasm-of-hepatic-flexure → Condition: malignant-neoplasm-of-transverse-colon →
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