Trial reportJournal of hematology & oncology2025
A phase II trial of anlotinib plus EGFR-TKIs in advanced non-small cell lung cancer with gradual, oligo, or potential progression after EGFR-TKIs treatment (CTONG-1803/ALTER-L001).
Trial report in Journal of hematology & 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 NCT04007835 (Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors), which is not on this map. Cited by 8 papers.
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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.
Safety and Efficacy of Anlotinib Hydrochloride Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKIs) in Treating Advanced Non-small-cell Lung Cancer (NSCLC) Patients With Acquired Resistance to EGFR TKIs
Who cites it
8 citing papers in PubMed.
- Prognostic analysis and beneficiary population exploration of subsequent treatment regimens after third-generation EGFR-TKIs failure in EGFR-mutated advanced non-small cell lung cancer: a retrospective cohort study.Translational lung cancer research · 2026Article
- Practice-Changing Advances in Systemic Therapies Shaping the Landscape of Lung Cancer in 2025.Cancer innovation · 2026Review
- The efficacy and safety of radiotherapy and immunotherapy with or without anlotinib in driver gene-negative advanced non-small cell lung cancer.Frontiers in oncology · 2026Article
- Anlotinib enhances the efficacy of KRAS-G12C inhibitors through c-Myc/ORC2 axis inhibition in non-small cell lung cancer.Cell death & disease · 2025Article
- Strategies Beyond 3rd EGFR-TKI Acquired Resistance: Opportunities and Challenges.Cancer medicine · 2025Review
- Efficacy and safety of anlotinib plus EGFR tyrosine kinase inhibitors in slow- or locally progressing non-small cell lung cancer after adjuvant therapy.Translational lung cancer research · 2025Article
- Synergizing Success: The Role of Anlotinib Combinations in Advanced Non-Small Cell Lung Cancer Treatment.Pharmaceuticals (Basel, Switzerland) · 2025Review
- 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
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe study is to evaluate the efficacy and safety of combined anlotinib and EGFR-tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC) who had gradual, oligo, or potential progression after previous EGFR-TKIs treatment.
methodsWe conducted an open-label, single-arm, multicenter, phase II trial in China. Eligible patients were 18-75 years old with histologically or cytologically confirmed NSCLC who were EGFR mutation positive and showed gradual, oligo, or potential progression after EGFR-TKIs. Anlotinib (12 mg/day) was administered orally for 2 weeks and then off 1 week in a 3-week cycle. EGFR-TKIs were continue used. The primary endpoint was progression-free survival (PFS). The secondary endpoints included 6- and 12-month PFS rate, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
resultsFrom July 2019 to December 2022, 120 patients were enrolled. The median PFS (mPFS) was 9.1 months (95% CI 6.8-11.7). The PFS rates at 6 and 12 months was 68.5% and 38.8% respectively. For 86 patients with first-line 1st /2nd generation EGFR-TKIs, the mPFS was 9.2 months (95% CI 6.7-12.6). For 32 patients with first-line 3rd generation EGFR-TKIs, the mPFS was 10.3 months (95% CI 6.1-13.3). Overall ORR and DCR were 6.7% (95% CI 2.9-12.7) and 87.5% (95% CI 80.2-92.8), respectively. 52.5% of patients had grade 3 or higher treatment-emergent adverse events (TEAEs).
conclusionAnlotinib in combination with continuation of EGFR-TKIs prolonged the clinical benefit of EGFR-TKIs, demonstrating favorable survival outcomes and manageable toxicity in NSCLC treated with EGFR-TKIs and had specific progression modes, such as gradual progression.
trial registrationNCT04007835.
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