Trial reportCancer medicine2025
An Open-Label, Single-Arm, Phase II Trial of Sintilimab Plus Anlotinib for Metastatic Non-Small Cell Lung Cancer After First-Line PD-(L)1 Inhibitor.
Trial report in Cancer 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 NCT04691388 (An Open-Label, Single-Arm, Phase II Trial of Sintilimab Combined With Anlotinib For Metastatic Non-Small Cell Lung Cancer After First-Line PD-1 Inhibitor), which is not on this map. Cited by 4 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.
An Open-Label, Single-Arm, Phase II Trial of Sintilimab Combined With Anlotinib For Metastatic Non-Small Cell Lung Cancer After First-Line PD-1 Inhibitor
Who cites it
4 citing papers in PubMed.
- An Open-Label, Single-Arm, Phase II Trial of Sintilimab Plus Anlotinib for Metastatic Non-Small Cell Lung Cancer After First-Line PD-(L)1 Inhibitor.Cancer medicine · 2025Trial
- Integration of immunogenic cell death in the treatment landscape of non-small cell lung cancer: harnessing the power of the immune system.Cell death discovery · 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 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
11 authors.
Funding
Abstract
backgroundAlthough immune checkpoint inhibitors (ICIs) have markedly improved first-line management of non-small cell lung cancer (NSCLC), many tumors eventually escape control after anti-PD-(L)1 therapy, leaving a clear therapeutic gap. Preclinical studies and preliminary clinical data suggest that coupling ICIs with anti-angiogenesis therapy can yield complementary antitumor effects. Consequently, we launched this investigation to evaluate the therapeutic benefit and tolerability of sintilimab, a PD-(L)1-blocking monoclonal antibody, together with the oral multi-target anti-angiogenesis agent anlotinib in metastatic NSCLC individuals experiencing progression after first-line PD-(L)1 inhibition.
methodsAt Zhejiang Cancer Hospital, we conducted a phase II trial, single-arm, open-label investigation (registration No. NCT04691388). Patients were adults diagnosed with metastatic NSCLC whose disease had advanced after PD-(L)1 blockade; they received sintilimab plus anlotinib on a 21-day cycle. Investigator-assessed objective response rate (ORR) served as the principal efficacy endpoint.
resultsBetween March 2021 and January 2024, twenty-nine individuals were recruited (median age 63, range 45-74, 96.6% male). Tumor assessment identified five partial responses (PR) (17.2%), nineteen cases of stable disease (SD) (65.5%) and three progressions (10.3%), yielding an ORR of 17.2% and a disease-control rate (DCR) of 82.8%. The cohort's median progression-free survival (PFS) measured 5.0 months (90% CI, 4.2-7.3), and 41.1% of participants remained progression-free at six months. Overall survival reached a median of 15.1 months (90% CI, 8.6-not yet reached), with an 18-month survival proportion of 44.8%. Grade ≥ 3 treatment-related toxicity was dominated by hypertension, occurring in 10.3% of participants; no patient discontinued therapy or died because of drug-related events.
conclusionSintilimab combined with anlotinib exhibited favorable antitumor activity and tolerable toxicity in post-anti-PD-(L)1 therapy of metastatic NSCLC patients, supporting further randomized controlled trials.
trial registrationClinicalTrials.gov: NCT04691388. Registered December 31, 2020.
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