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Drug

Lenvatinib

In clinical development
Emerging researchLate-stage developmentSteady momentum

Also known as Lenvima, Lenvima 20 mg daily-dose, Lenvima 8 mg daily-dose.

RxNorm1603296ChEMBLCHEMBL1289601ATCL01EX08UNIIEE083865G2
6
Research papers
92
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib, Pembrolizumab and FLOT in the Neoadjuvant / Adjuvant Treatment for Patients With Gastric Cancer

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants

Clinical trial2026-07-30Results expected Q3 2026 · ClinicalTrials.gov

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Clinical trial2026-07-20Results posted · ClinicalTrials.gov

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Clinical trial2026-07-20Status changed to Completed · ClinicalTrials.gov

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B in Second-Line Metastatic Participants

Clinical trial2026-07-17Primary completion · ClinicalTrials.gov

A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma

Clinical trial2026-07-16Status changed to Active, not recruiting · ClinicalTrials.gov

A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma

Clinical trial2026-07-16Results expected Q4 2027 · ClinicalTrials.gov

Immunomodulation of the Tumor Microenvironment in High-Grade Serous Ovarian Cancer Patients Receiving Pembrolizumab and Lenvatinib Monotherapy and Combination Therapy

Clinical trial2026-07-16Results expected Q1 2027 · ClinicalTrials.gov

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

Research2024-06-04Journal of clinical oncology : official journal of the American Society of Clinical Oncology

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Research2024-03-15Cancer treatment reviews

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer.

Research2022-01-19The New England journal of medicine

Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results.

Research2020-11-16BMC cancer

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lenvatinib
Aliases & brands
LenvimaLenvima 20 mg daily-doseLenvima 8 mg daily-dose
RxNorm CUI
1603296
ChEMBL ID
CHEMBL1289601
ATC codes
L01EX08
UNII
EE083865G2

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
197
registered trials across all phases
LATEST COMPLETION 2026
92
Active studies
60
Recruiting
44
Late-stage (III+)
57
Completed
48
Discontinued
PHASE DISTRIBUTIONn = 197
Early Phase 14Phase 124Phase 1 / 223Phase 2102Phase 2 / 35Phase 326Phase 41Phase N / A12

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prospective Single Arm Post Marketing Phase IV Study to Assess the Safety and Efficacy of Lenvatinib in Subjects With Locally Recurrent or Metastatic, Progressive, Radioiodine Refractory Differentiated Thyroid Cancer

CompletedPH IVEisai Pharmaceuticals India Pvt. Ltdn=502025

A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab

RecruitingPH IIIKey trialMerck Sharp & Dohme LLCn=3,5002043

Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

RecruitingPH IIISWOG Cancer Research Networkn=7182034

Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study

Not yet recruitingPH IIITianjin Medical University Cancer Institute and Hospitaln=1982030

A Multicenter, Randomized, Open-Label Phase II/III Clinical Study on the Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 Versus Investigator's Choice of Chemotherapy in Advanced Recurrent/Metastatic Cervical Cancer

Not yet recruitingPH II/IIIL & L Bio Co., Ltd., Ningbo, Chinan=1202028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

CompletedPH IIIMerck Sharp & Dohme LLCn=8632026

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

CompletedPH IIIMerck Sharp & Dohme LLCn=4792026

A Multicentric, Open-Label, Single Arm Phase II Study To Evaluate The Efficacy And Safety Of The Combination Of PEmbrolizumab And Lenvatinib In Pre-Treated Thymic Carcinoma PaTIents. PECATI.

CompletedPH IIMedSIRn=432026

The Efficacy and Safety of PD-1 Inhibitor Combined With Lenvatinib or With Regorafenib For Advanced Hepatocellular Carcinoma After Failure of First-line Bevacizumab Plus Sintilimab: A Retrospective Study

CompletedN/ASun Yat-sen Universityn=2002025

A Single-arm Phase Ib/II Study of the Combination of Lenvatinib and Eribulin in Advanced Adipocytic Sarcoma and Leiomyosarcoma (LEADER Study)

CompletedPH I/IINational Taiwan University Hospitaln=302025

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors

CompletedPH IMerck Sharp & Dohme LLCn=4702025

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192024
Most influential

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer.

The New England journal of medicine · 2022 · 708 cites

Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway.

PloS one · 2019 · 383 cites

Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.

Journal of experimental & clinical cancer research : CR · 2019 · 162 cites

Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results.

BMC cancer · 2020 · 76 cites

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 69 cites

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Cancer treatment reviews · 2024 · 17 cites
Recent papers

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 69 cites

The more the merrier? Evidence and efficacy of immune checkpoint- and tyrosine kinase inhibitor combinations in advanced solid cancers.

Cancer treatment reviews · 2024 · 17 cites

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer.

The New England journal of medicine · 2022 · 708 cites

Phase 2 study of lenvatinib monotherapy as second-line treatment in unresectable biliary tract cancer: primary analysis results.

BMC cancer · 2020 · 76 cites

Lenvatinib plus anti-PD-1 antibody combination treatment activates CD8+ T cells through reduction of tumor-associated macrophage and activation of the interferon pathway.

PloS one · 2019 · 383 cites

Molecular targeted and immune checkpoint therapy for advanced hepatocellular carcinoma.

Journal of experimental & clinical cancer research : CR · 2019 · 162 cites
Major research themes8
Phenylurea Compounds2Quinolines2Antibodies, Monoclonal, Humanized1Antineoplastic Combined Chemotherapy Protocols1Carcinoma, Hepatocellular1Carcinoma, Renal Cell1Colorectal Neoplasms1Kidney Neoplasms1
Journals, researchers & institutions
Top journals
  • BMC cancer1
  • Cancer treatment reviews1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • Journal of experimental & clinical cancer research : CR1
  • PloS one1
  • The New England journal of medicine1
Leading researchers
  • Adelberg D1
  • Ananda S1
  • Baron-Hay S1
  • Berghoff AS1
  • Bird S1
  • Casado Herráez A1
  • Colomba E1
  • Colombo N1
Leading institutions
free-text, unnormalised
  • National Cancer Center Hospital East2
  • Aichi Cancer Centre Hospital1
  • Asan Medical Center1
  • Cancer Institute Hospital of JFCR1
  • Comprehensive Cancer Center at Ludwig Maximilian University of Munich1
  • Guangxi Medical University Cancer Hospital1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Pembrolizumab

Studied across 6 of the same disease areas as Lenvatinib in the shared literature.

6 shared diseases2 shared papers
Regorafenib

Studied across 3 of the same disease areas as Lenvatinib in the shared literature.

3 shared diseases2 shared papers
Axitinib

Studied across 4 of the same disease areas as Lenvatinib in the shared literature.

4 shared diseases1 shared paper
Cabozantinib

Studied across 4 of the same disease areas as Lenvatinib in the shared literature.

4 shared diseases1 shared paper
Sorafenib

Studied across 3 of the same disease areas as Lenvatinib in the shared literature.

3 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials