Trial reportBMC medicine2025
Osimertinib plus anlotinib for advanced NSCLC with acquired EGFR T790M mutation: results from a multicenter phase II study with ctDNA analysis.
Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04029350 (A Multi-center, One-arm, Phase II Trial of Anlotinib Combined With Osimertinib as the Second-line Treatment in Stage IIIb-IV NSCLC With Confirmed EGFRm and T790M.), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
A Multi-center, One-arm, Phase II Trial of Anlotinib Combined With Osimertinib as the Second-line Treatment in Stage IIIb-IV NSCLC With Confirmed EGFRm and T790M.
Who cites it
5 citing papers in PubMed.
- Osimertinib plus anlotinib in untreated, EGFR-mutated, advanced non-small-cell lung cancer with concurrent alterations: a multicenter phase II study.The oncologist · 2026Trial
- Association between C-reactive protein-to-albumin ratio and the risk of overall survival in advanced non-small cell lung cancer patients with anlotinib treatment: a retrospective cohort study.BMC pulmonary medicine · 2026Article
- Multidimensional tumor heterogeneity and its role in therapeutic resistance.Frontiers in immunology · 2026Review
- A predictive model for anlotinib-osimertinib efficacy in advanced non-small cell lung cancer with acquired resistance: circulating tumor DNA and angiogenesis markers.American journal of translational research · 2025Article
- Anlotinib added to third generation EGFR tyrosine kinase inhibitor therapy for advanced NSCLC patients with oligo-progression: a retrospective study (ALTER-L058).Frontiers in pharmacology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
backgroundOsimertinib is a standard treatment for first- or second-line therapy in patients with non-small cell lung cancer (NSCLC) harboring mutations in the epidermal growth factor receptor (EGFR). However, options are limited for patients with acquired EGFR T790M mutations resistant to first- or second-generation EGFR-tyrosine kinase inhibitors (TKIs). This study assessed the efficacy and safety of combining osimertinib with anlotinib in this patient population and explored circulating tumor DNA (ctDNA) as a biomarker of treatment outcomes.
methodsIn this prospective, single-arm, phase II trial, 31 patients with advanced NSCLC resistant to prior first- or second-generation EGFR-TKIs therapy received osimertinib (80 mg daily) and anlotinib (12 mg daily on days 1-14 of each 21-day cycle). Efficacy endpoints included progression-free survival (PFS) and overall survival (OS). ctDNA was analyzed using next-generation sequencing (NGS) to monitor mutation status and treatment response.
resultsThe median PFS was 16.2 months (95% confidence interval [CI] 9.8-23.6, 90% CI 14.2-20.9), and the median OS was 31.4 months (95% CI 27.3-not reached). The objective response rate (ORR) was 45.2% (95% CI 30.6-66.6%), with a disease control rate (DCR) of 96.8% (95% CI 86.3-100.0%). ctDNA analysis showed that activating EGFR mutation clearance after two treatment cycles correlated with significantly longer PFS and OS. The regimen was well-tolerated, with no grade 4 or higher adverse events observed.
conclusionsOsimertinib combined with anlotinib demonstrates promising long-term efficacy and manageable safety in EGFR T790M-positive NSCLC. Clearance of ctDNA, particularly of EGFR mutations, could serve as a valuable predictive biomarker, supporting the implementation of personalized treatment strategies.
trial registrationClinicalTrials.gov, NCT04029350.
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