multi-kinase inhibitor · small molecule

anlotinib

19 active trials across 14 of our biomarkers, targeting VEGFR (multi-kinase). Not approved for any biomarker on marked.bio yet.

Also known as AL3818.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

Biomarker	Active trials	All trials	Furthest active phase
EGFR exon 19 deletion / L858R	11	29	Phase 3
KRAS G12C	3	3	Phase 2
HER2-low / ultralow (IHC 1+ or 2+/ISH-)	2	3	Phase 2
KRAS G12D	2	3	Phase 2
BRAF V600E	1	1	Phase 4
Claudin 18.2 expression	1	2	Phase 2
MSI-H / dMMR	1	3	Phase 2
NTRK1/2/3 fusion	1	1	Phase 4
RET fusion or mutation	1	1	Phase 4
ALK fusion	0	2	–
BRCA1/2 mutation	0	1	–
EGFR exon 20 insertion	0	1	–
FGFR2 fusion or rearrangement	0	2	–
FGFR3 alteration (mutation or fusion)	0	2	–

Trials

19 of 46 trials shown

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting Phase 4 Fujian Medical University Started 2025Primary completion 2027-12 NCT07010393

dabrafenib FDA EUtrametinib FDA EUselpercatinibpralsetiniblenvatiniblarotrectinibanlotinibpembrolizumabsintilimabcabozantinibBemosuzumab

BRAF V600E mutation

BRAF V600ERET fusion or mutationNTRK1/2/3 fusionThyroid Neoplasms
Almonertinib Combined With Anlotinib as First-line Treatment for Advanced Non-small Cell Lung Cance

Recruiting Phase 3 Qianfoshan Hospital Started 2023Primary completion 2026-09 NCT06043973

aumolertinibanlotinib

Patients with EGFR mutation and TP53 mutation advanced Non-squamous NSCLC.

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-09-21Advanced Non-small Cell Lung Cancer
The Study Of Andamertinib Plus Anlotinib In Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Not yet recruiting Phase 2 Fudan University Started 2026Primary completion 2028-09 NCT07780578

Andamertinibanlotinib

Harboring EGFR mutations (including exon19 deletions and exon21 L858R mutation), with documented disease progressed following only one prior …

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Neoadjuvant Therapy With Firmonertinib Combined With Anlotinib and Platinum-Based Doublet Chemotherapy for Resectable EGFR-Mutated NSCLC

Not yet recruiting Phase 2 Hubei Cancer Hospital Started 2026Primary completion 2028-03 NCT07807722

furmonertinibanlotinib

EGFR mutation positive non-small cell lung cancer (including 19Del and 21L858R) confirmed by biopsy

EGFR exon 19 deletion / L858RNSCLC (Non-small Cell Lung Cancer), EGFR, Neoadjuvant Therapy
A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC

Recruiting Phase 2 Fosun Pharma Started 2026Primary completion 2029-06 NCT07562581

luvometinibanlotinib

KRAS mutation positive.

KRAS G12CKRAS G12DNon-small Cell Lung Caner, KRAS-mutated, Metastasis, Previous Treamted
Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

Not yet recruiting Phase 2 Sun Yat-sen University Started 2025Primary completion 2028-10 NCT07294261

garsorasibbenmelstobartanlotinibcetuximab

Garsorasib In KRAS G12C Mutant Locally Advanced and Metastatic NSCLC

KRAS G12CLocal Advanced or Metastatic NSCLC
A Study of Sunvozertinib Combined With Anlotinib in Local Advanced or Metastatic Non-small Cell Lung Cancer

Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2024Primary completion 2026-01 NCT06182761

sunvozertinibanlotinib

EGFR sensitive mutations confirmed by accredited local laboratories， including 19del、L858R and T790M。

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-12-27NSCLC
Furmonertinib Combined With Anlotinib in Lung Adenocarcinoma Patients With EGFR Mutations and Brain Metastases

Not yet recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2024Primary completion 2025-12 NCT06483672

furmonertinibanlotinib

Tumor tissue samples or blood samples are confirmed to be EGFR mutations;

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-07-03Adenocarcinoma of Lung Metastatic to Brain
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC

Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024Primary completion 2025-10 NCT06348927

sunvozertinibanlotinib

EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, includi…

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-19Non-Small Cell Lung Cancer
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW

Recruiting Phase 2 Hunan Province Tumor Hospital Started 2024Primary completion 2025-12 NCT06355609

sunvozertinibanlotinib

EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, includi…

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2024-09-20Non-small Cell Lung Cancer
Trametinib Plus Anlotinib Combined With Tislelizumab in KRAS-mutant NSCLC

Not yet recruiting Phase 1/2 Shanghai Chest Hospital Started 2024Primary completion 2026-06 NCT06456138

trametinibanlotinibtislelizumab

KRAS mutation positive detected by ARMS or NGS;

KRAS G12CKRAS G12DStatus may be outdated, last updated 2024-06-13KRAS Mutation-Related Tumors, Advanced Lung Cancer, Refractory Tumor
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed

Not yet recruiting Phase 2 Guangdong Provincial People's Hospital Started 2024Primary completion 2026-06 NCT06547476

tislelizumabanlotinib

Has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)

HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-08-09Breast Cancer
Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation

Not yet recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2023Primary completion 2025-03 NCT05778149

aumolertinibanlotinib

Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-03-21Aumolertinib, Anlotinib, TP53, NSCLC
A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

Recruiting Phase 2 LaNova Medicines Zhejiang Started 2023Primary completion 2031-08 NCT05934331

LM-302toripalimabcapecitabineTegafur, Gimeracil and Oteracil Potassium Capsulesnivolumabapatinibgemcitabinetislelizumabanlotinibbenmelstobart

CLDN18.2-positive subjects.

Claudin 18.2 expressionMalignant Neoplasms of Digestive Organs
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

Recruiting Phase 1/2 Shanghai Chest Hospital Started 2022Primary completion 2025-01 NCT05271916

dacomitinib FDA EUanlotinib

It is acceptable for subjects with the presence of EGFR activating mutation (exon 19 deletion and the L858R mutation in exon 21) to be included in this Phase I study

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-04-19Non-Small Cell Lung Cancer (NSCLC)
Camrelizumab Plus Anlotinib in Patients With Recurrent Sporadic MMRd Endometrial Cancer

Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2022Primary completion 2025-11 NCT05550558

anlotinibcamrelizumab

Tumors must demonstrate MMRd and MLH1 methylation.

MSI-H / dMMRStatus may be outdated, last updated 2022-09-28Endometrial Cancer
Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC

Recruiting Phase 2 Fudan University Started 2021Primary completion 2026-12 NCT04136535

pemetrexedcarboplatinanlotinib

Presence of EGFR activating mutations and previously disease progression to Osimertinib (previously treated with 1st / 2nd gen…

EGFR exon 19 deletion / L858RNSCLC Stage IV
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

Recruiting Phase 1 Fudan University Started 2024Primary completion 2026-12 NCT06331169

anlotinibtrastuzumab deruxtecan FDA EU

Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).

HER2-low / ultralow (IHC 1+ or 2+/ISH-)Status may be outdated, last updated 2024-08-30Breast Cancer
A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation

Recruiting No phase Kunming Medical University Started 2023Primary completion 2026-10 NCT06102928

anlotinibaumolertinib

… IIIB, IIIC, or IV) confirmed by histology or cytology, with the presence of EGFR 21 exon L858R mutation in the driving gene

EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-10-26Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Concomitant Mutation NSCLC

Unknown status Phase 3 Tianjin Medical University Cancer Institute and Hospital Started 2021 NCT04797806

anlotinibicotinib

…rent non-squamous NSCLC（according to the 8th Edition of the AJCC Staging system）with EGFR 19 del or 21 L858R gene mutation and concomitant others.

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
A Clinical Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsules Versus K Drug in the Treatment of First-line Non-small Cell Lung Cancer(NSCLC)

Unknown status Phase 3 Chia Tai Tianqing (Sino Biopharm) Started 2021 NCT04964479

benmelstobartanlotinibpembrolizumab

…factor receptor (EGFR) mutations and ALK fusions (for squamous NSCLC, patients with known EGFR mutations and anaplastic Lymphoma kinase (ALK) fusions need to be excluded, and those with unknown …

EGFR exon 19 deletion / L858RALK fusionNon Small Cell Lung Cancer
Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated EGFR-mutant NSCLC

Unknown status Phase 3 Sun Yat-sen University Started 2019 NCT04028778

gefitinib FDA EUanlotinib

5.Documented evidence of tumor harboring an activating EGFR mutation (exon19 del and L858R)

EGFR exon 19 deletion / L858RLung Cancer, Nonsmall Cell
Anlotinib, TQB2450 (PD-L1 Inhibitor), and Albumin-bound Paclitaxel Regimens in the Treatment of GC/GEJA

Unknown status Phase 2 Peking University Started 2024 NCT06222944

anlotinibbenmelstobartnab-paclitaxelpaclitaxel

Patients who have failed first-line treatment with CLDN18.2-related regimen (CLDN18.2 drugs include CLDN18.2 monotherapy, CLDN18.2 dual therapy, CLDN…

Claudin 18.2 expressionGastric Cancer, Adenocarcinoma of Esophagogastric Junction
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer

Unknown status Phase 2 Qilu Hospital of Shandong University Started 2023 NCT06000033

disitamab vedotinanlotinib

…within 6 months) or fresh biopsy lesions were negative for ER and PR, while patients with low HER-2 expression were HR -, HER2IHC1+, or HER2IHC2+and ISH negative;

HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer
To Evaluate the Efficacy and Safety of Anlotinib Combined With Furmonertinib Mesylate in Lung Cancer

Completed Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2021 NCT04671303

anlotinibfurmonertinib

The previous report confirmed the presence of an EGFR gene exon 19 deletion mutation or exon 21 L858R mutation, and the investigator verified that the report reflect…

EGFR exon 19 deletion / L858RLung Cancer
Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

Unknown status Phase 2 Shanghai Chest Hospital Started 2021 NCT04895930

furmonertinibanlotinib

The tumour harbours one of the most common EGFR mutations (19del or L858R) ;

EGFR exon 19 deletion / L858RNon-Small-Cell Lung Cancer
the Efficacy and Safety of Anlotinib Combined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer

Unknown status Phase 2 Li-kun Chen Started 2021 NCT04978753

anlotinibaumolertinib

…ined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, Brain Metastases
Fulvestrant Plus Anlotinib in HR(+)/HER2(-) Metastatic Breast Cancer With FGFR Mutation

Unknown status Phase 2 Sun Yat-sen University Started 2021 NCT04936295

fulvestrantanlotinib

There are FGFR mutations, which meets any of the following: ①Immunohistochemical method: any subtype of FGFR1/2/3/…

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementBreast Cancer
Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

Unknown status Phase 2 Peking University Started 2021 NCT04777162

tislelizumabanlotinib

…nosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;

MSI-H / dMMRGastric Cancer, Colo-rectal Cancer
Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

Completed Phase 1/2 Shanghai Chest Hospital Started 2020 NCT04770688

osimertinib FDA EUanlotinib

…s one of the most common EGFR mutations known to be associated with EGFR-TKI sensitivity (exon 19 deletion

EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With EGFR Mutation, Locally Advanced Solid Tumor, Metastatic Cancer, Adenocarcinoma of Lung
Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Treatment With Gefitinib

Unknown status Phase 2 Second Affiliated Hospital of Nanchang University Started 2020 NCT04358562

gefitinib FDA EUanlotinib

Histologically confirmed that EGFR sensitive mutation (ex19del or L858R mutation) in tumor tissue was detected by non-squamous NSCLC, and EGFR mutation …

EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer, EGFR Gene Mutation
A Trial of Anlotinib Combined With Docetaxel in EGFR Mutations Advanced Non Small Cell Lung Cancer Patients

Unknown status Phase 2 Shandong Cancer Hospital and Institute Started 2020 NCT04619563

anlotinibdocetaxel

EGFR mutation-positive、ALK mutation-negative；Patients have progressed after receiving EGFR targeted and…

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Anlotinib and Niraparib Dual Therapy Evaluation in Platinum-resistant Recurrent Ovarian Cancer

Unknown status Phase 2 Jihong Liu Started 2020 NCT04376073

niraparib FDA EUanlotinib

Subject agrees to take blood samples for gBRCA mutations

BRCA1/2 mutationPlatinum-resistant Ovarian Cancer
A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor

Unknown status Phase 2 Chia Tai Tianqing (Sino Biopharm) Started 2020 NCT04291248

penpulimabanlotinib

Histopathologically confirmed MSI-H or dMMR advanced malignant solid tumors. 2.

MSI-H / dMMRMSI-H or dMMR Advanced Solid Tumors
Study of Anlotinib Combined With Osimertinib as Second-line Treatment in Stage IIIb-IV NSCLC With Confirmed EGFRm and T790M

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2019 NCT04029350

anlotinibosimertinib FDA EU

Non-small cell lung cancer (NSCLC) with an activating EGFR mutation (exon 19 deletion, L858R point mutation, or any other mutation known to be associated with EGFR TKI sensiti…

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations

Completed Phase 2 Zhejiang Cancer Hospital Started 2019 NCT04790409

sintilimabanlotinib

Patients with EGFR 20ins who have experienced disease progression only after platinum-containing systemic chemothe…

EGFR exon 20 insertionLung Cancer
Study of Anlotinib Combined With Icotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC

Completed Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2018 NCT03736837

anlotinibicotinib

…rent non-squamous NSCLC（according to the 8th Edition of the AJCC Staging system）with EGFR 19 del and/or 21 L858R gene mutation

EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer
Efficacy and Safety of Anlotinib Plus Platinum Plus Pemetrexed in T790M-negative NSCLC

Unknown status Phase 1/2 Sichuan Cancer Hospital and Research Institute Started 2018 NCT03706287

anlotinibpemetrexedcisplatincarboplatin

Epidermal Growth Factor Receptor(EGFR)mutations confirmed by molecular detection (including, but not limited to 19 exon deletion and L858…

EGFR exon 19 deletion / L858RLung Cancer Metastatic
Anlotinib Plus Chemotherapy for Patients With Advanced Non-small Cell Lung Cancer

Unknown status Phase 2 The First People's Hospital of Lianyungang Started 2018 NCT03589950

anlotinibchemotherapy

…who have previously received one lines chemotherapy, EGFR TKI or ALK inhibitor (whom with EGFR or ALK mutation but not with T790 M positive) treatment before participating；

EGFR exon 19 deletion / L858RALK fusionLung Neoplasms, Docetaxel, Pemetrexed, S-1
Anlotinib Plus Sintilimab for NSCLC Patients With First-generation EGFR-TKIs Drug Resistance Along With T790M Negative

Unknown status Phase 2 First Hospital of Shijiazhuang City Started 2018 NCT03765775

sintilimabanlotinib

Has confirmation that epidermal growth factor receptor (EGFR) mutation，with first-generation EGFR-TKIs drug resistance T790M negative .

EGFR exon 19 deletion / L858RCarcinoma, Non-small Cell Lung Cancer, Lung Neoplasm
Trametinib Plus Anlotinib in Non-G12C KRAS-Mutant NSCLC Patients

Completed Phase 1 Shanghai Chest Hospital Started 2021 NCT04967079

trametinibanlotinib

KRAS mutation positive excluded KRASG12C mutation.

KRAS G12DNon Small Cell Lung Cancer
Anlotinib Hydrochloride Combined With EGFR TKIs in Advanced Non-small Cell Lung Cancer

Unknown status No phase The First Affiliated Hospital of Soochow University Started 2019 NCT03766490

anlotinibgefitinib FDA EUicotinib

Previously, EGFR gene test showed EGFR exon 19 deletion or exon 21 (L858R) mutation, and the gene test showed no T790M mutation before enrollment…

EGFR exon 19 deletion / L858RNon-Small-Cell Lung
Anlotinib Hydrochloride Combined With EGFR-Tyrosine Kinase Inhibitor (TKI) in Treating Advanced NSCLC Patients With Acquired Resistance to EGFR-TKI

Unknown status No phase Guangdong Association of Clinical Trials Started 2019 NCT04007835

anlotinibgefitinib FDA EUerlotinib FDA EUicotinib

The patients should be confirmed with EGFR mutation \[e.g., T 790 M , exon 19 deletion, L 858 R, etc\],

EGFR exon 19 deletion / L858RNSCLC
Anlotinib in Advanced Solid Tumors With FGFR Alteration

Unknown status No phase Shanghai Changzheng Hospital Started 2019 NCT03929965

anlotinib

Patients with FGFR mutation(including mutation, fusion, rearrangements )

FGFR3 alteration (mutation or fusion)FGFR2 fusion or rearrangementAdvanced Solid Tumor
Phase I Study of the Combination of Anlotinib With Gefitinib

Unknown status No phase Second Affiliated Hospital of Nanchang University Started 2018 NCT03602027

anlotinibgefitinib FDA EU

…rmed by molecular detection (including, but not limited to, 20 exon, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test res…

EGFR exon 19 deletion / L858RNon-squamous Non-small Cell Lung Cancer
Non Squamous NSCLC Patients With Anlotinib Combined With Pemetrexed and Cisplatin

Unknown status No phase Lingyu Luo Started 2018 NCT03671538

anlotinibpemetrexedcisplatin

…firmed by molecular detection (including, but not limited to, T790M, 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test res…

EGFR exon 19 deletion / L858RNon-squamous Non-small Cell Lung Cancer

Biomarkers

Sponsors

Trials