Last reviewed · How we verify
NCT04978753
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
Phase 2 trial testing Anlotinib in Non-small Cell Lung Cancer in 54 participants. Status unknown.
30 May 2022
Quick facts
| Lead sponsor | Li-kun Chen |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 1 May 2021 |
| Primary completion | 30 May 2022 |
| Estimated completion | 30 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Anlotinib — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- Brain Metastases — all drugs for Brain Metastases →
Sponsor
Li-kun Chen — full company profile →
Who can join
Adults 18 to 75, any sex, with Non-small Cell Lung Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Subject population：Patients with brain metastases from EGFR mutation-positive non-small cell lung cancer who have not received systemic treatment. Experimental design: Single-center, single-arm phase II clinical trial. Purpose: Efficacy and safety of Anlotinib combined with Almonertinib in the treatment of patients with brain metastases from EGFR mutation-positive non-small cell lung cancer. treatment plan: 1). Anlotinib: 12mg/time (BSA≥1.6 m2) or 10mg/time (BSA\<1.6 m2), once a day orally, taking two weeks and stopping for one week; 2). Almonertinib: 110mg, orally once a day; primary endpoint: Intracranial progression-free survival (iPFS); secondary endpoint: Objective intracranial response rate (iORR=iCR+iPR), intracranial disease control rate (iDCR=iCR+iPR+i SD), overall progression-free survival (PFS), overall survival (OS), quality of life score.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Exploring the Molecular Tumor Microenvironment and Translational Biomarkers in Brain Metastases of Non-Small-Cell Lung Cancer.
Wen J, Yu JZ, Liu C, Ould Ismail AAO, et al · · 2024 · cited 13× · PMID 38396722 · DOI 10.3390/ijms25042044 -
Efficacy and safety with aumolertinib plus anlotinib for untreated EGFR-mutant NSCLC with brain metastases.
Chen J, Pan Y, Li M, Yu H, et al · · 2025 · PMID 41326640 · DOI 10.1038/s41698-025-01191-2
Verify or expand the search:
- PubMed search for NCT04978753
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Anlotinib
Trials testing the same drug.
- NCT07470840 — SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma · Phase 2 · not yet recruiting
- NCT07537777 — Benmelstobart Plus Anlotinib Combined With SBRT for Patients With Hepatocellular Carcinoma Failing First-Line Targeted T · Phase 2 · not yet recruiting
- NCT07320963 — Chidamide in Combination With Toripalimab and Anlotinib in Recurrent/Metastatic Nasopharyngeal Carcinoma. · Phase 1, PHASE2 · not yet recruiting
- NCT07388875 — Sacituzumab Tirumotecan Plus Anlotinib in Previously Treated ES-SCLC · Phase 2 · not yet recruiting
- NCT07376499 — Prospective, Single-arm, Phase II Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Platinum a · Phase 2 · not yet recruiting
Other recruiting trials for Non-small Cell Lung Cancer
Currently open trials in the same condition.
- NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
- NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
- NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
- NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
- NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting
Other Li-kun Chen trials
Trials by the same sponsor.
- NCT07197008 — Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous N · Phase 2 · not yet recruiting
- NCT06728852 — Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Pa · Phase 2 · recruiting
- NCT06728865 — Evaluation of the Efficacy and Safety of Furmonertinib Combined with Bevacizumab As First-Line Treatment for EGFR-Positi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04978753 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Li-kun Chen
- Last refreshed: 27 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04978753.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing