Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04662710 (Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The efficacy and safety of pembrolizumab in the treatment of HER2-negative advanced gastric or gastroesophageal junction cancer: a systematic review and meta-analysis of emerging clinical data.Frontiers in immunology · 2026Pooled it
- Sintilimab plus Bevacizumab biosimilar IBI305 and chemotherapy as a first-line treatment in advanced gastric or gastroesophageal junction adenocarcinoma (SBAGA): a single-arm, phase Ib/II study.Nature communications · 2026Trial
- Beyond LEAP-015: the ongoing challenge of vascular endothelial growth factor inhibition in gastric cancer.Journal of gastrointestinal oncology · 2026Article
- Spatial single-cell multi-omics characterization of the tumor microenvironment heterogeneity by HER-2 expression status in gastric cancer.Molecular cancer · 2026Article
- Bridging paradigms and shaping the future of resectable gastric cancer: a narrative review of the post-MATTERHORN era.Gastroenterology report · 2026Review
- Spatial immune niches in gastric cancer immunotherapy resistance: mechanisms and translational implications.Frontiers in immunology · 2026Review
- Late-phase strategies to overcome limitations of PD-1/PD-L1 therapy: a clinical development trajectory through 2030.Frontiers in oncology · 2026Review
- First-Line Tislelizumab Combined with Bevacizumab and CAPOX for Metastatic Gastroesophageal Adenocarcinoma with Low Programmed Death-Ligand 1 Expression.Cancer communications (London, England) · 2026Article
- Neoadjuvant Chemotherapy for Gastric Cancer: Evolving Approaches and Supporting Evidence.Journal of gastric cancer · 2026Review
- Highlights from the 2025 ASCO Annual Meeting.Nature cancer · 2025Article
- Current Advances and Future Directions for Sensitizing Gastric Cancer to Immune Checkpoint Inhibitors.Cancer medicine · 2025Review
- Immune Checkpoint Inhibitors in Gastrointestinal Cancers: Current Evidence and Future Directions.Oncology research · 2025Review
- Comparison of Alpha-fetoprotein-positive and AFP-negative patients with advanced gastroesophageal junction or gastric cancer receiving immunotherapy: an analysis stratified by HER2 status.American journal of cancer research · 2025Article
- Advances in therapeutic approaches to gastric cancer.CA: a cancer journal for cliniciansReview
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Authors and funding
27 authors.
Funding
Abstract
purposeThe phase III randomized open-label LEAP-015 study (ClinicalTrials.gov identifier: NCT04662710) evaluated first-line lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy for advanced metastatic gastroesophageal adenocarcinoma.
methodsEligible participants 18 years and older with untreated human epidermal growth factor receptor 2-negative locally advanced unresectable or metastatic gastroesophageal adenocarcinoma were randomly assigned 1:1 to induction with oral lenvatinib 8 mg once daily plus pembrolizumab 400 mg intravenously once every 6 weeks (×2) and investigators' choice of capecitabine and oxaliplatin once every 3 weeks (×4) or fluorouracil, leucovorin, and oxaliplatin once every 2 weeks (×6) and consolidation with lenvatinib plus pembrolizumab, or chemotherapy. Dual primary end points were progression-free survival (PFS) and overall survival (OS) in participants with PD-L1 combined positive score (CPS) ≥1 and all participants. Secondary end points included objective response rate (ORR) and duration of response.
resultsOf 880 participants randomly assigned, 443 received lenvatinib plus pembrolizumab and 437 received chemotherapy. The median follow-ups were 32.2 months (range, 19.0-41.7) in participants with PD-L1 CPS ≥1 and 31.8 months (19.0-41.7) in all participants. At interim analysis, PFS was statistically significant with lenvatinib plus pembrolizumab versus chemotherapy in participants with PD-L1 CPS ≥1 (median, 7.3
conclusionLenvatinib plus pembrolizumab and chemotherapy versus chemotherapy provided a statistically significant improvement in PFS in advanced unresectable or metastatic gastroesophageal carcinoma at interim analysis although the clinical significance of this difference seems to be limited. No significant improvement occurred in OS in participants with PD-L1 CPS ≥1.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.