Trial reportCancer communications (London, England)2022
Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3).
Trial report in Cancer communications (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 5 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
46 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Grade ≥ 3 hematologic adverse events of immunotherapy in advanced NSCLC patients: a systematic review and meta-analysis.European journal of clinical pharmacology · 2025Pooled it
- Optimal early endpoint for second-line or subsequent immune checkpoint inhibitors in previously treated advanced solid cancers: a systematic review.BMC cancer · 2025Pooled it
- Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis.Frontiers in immunology · 2025Pooled it
- Cost-effectiveness of immunotherapies for advanced squamous non-small cell lung cancer: a systematic review.BMC cancer · 2024Pooled it
- The risk of endocrine immune-related adverse events induced by PD-1 inhibitors in cancer patients: a systematic review and meta-analysis.Frontiers in oncology · 2024Pooled it
- Trial
- Sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer.Journal for immunotherapy of cancer · 2024Trial
- Sintilimab in combination with stereotactic body radiotherapy and granulocyte-macrophage colony-stimulating factor in metastatic non-small cell lung cancer: The multicenter SWORD phase 2 trial.Nature communications · 2024Trial
- Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer: an open-label, randomized controlled phase 3 trial (ORIENT-3).Cancer communications (London, England) · 2022Trial
- Optimal drug regimens for squamous non-small cell lung cancer: a systematic review and a Bayesian network meta-analysis of randomized trials.Journal of thoracic disease · 2026Article
- Prospective Multicenter Observational Study of Anlotinib in Advanced Non-Small Cell Lung Cancer: Real-World Evidence From China.Thoracic cancer · 2026Observational
- Efficacy and safety comparisons of PD-1 versus PD-L1 inhibitors in patients with solid cancer: a systematic review and meta-analysis.Journal of the National Cancer Center · 2026Article
- DSG2+ Cancer Stem Cells Co-Located With FAP+ Myofibroblasts in the Tumor Boundary That Determines the Efficacy of Immunotherapy in Non-Small Cell Lung Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Tuberculosis Preceding Lung Cancer: A Contemporary Meta-Analysis Revealing a Critical Gap in Post-2020 Evidence.Cancers · 2026Review
- Efficacy and safety of sintilimab in the treatment of sqNSCLC.Pakistan journal of medical sciences · 2026Article
- Efficacy, safety, and exploratory biomarker analysis of rechallenge with immune checkpoint inhibitors combined with anlotinib in previously treated advanced non-small cell lung cancer.BMC pulmonary medicine · 2026Article
- The efficacy and safety of four different PD-1 checkpoint inhibitors in advanced non-small cell lung cancer: a real-world retrospective study.Frontiers in oncology · 2026Article
- Integrated metabolomics and machine learning identify predictive biomarkers via SHAP analysis for sintilimab-induced rash in lung cancer patients.Frontiers in pharmacology · 2026Article
- Review
- Immune checkpoint inhibitors for the treatment of solid tumors and lymphoma in the past 26 years (2000-2025).Journal of hematology & oncology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
46 authors at 20 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer (sqNSCLC) after failure of first-line chemotherapy are limited. This study (ORIENT-3) aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.
methodsORIENT-3 was an open-label, multicenter, randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy. Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m
resultsBetween August 25, 2017, and November 7, 2018, 290 patients were randomized. For FAS, 10 patients from the docetaxel arm were excluded. The median OS was 11.79 (n = 145; 95% confidence interval [CI], 10.28-15.57) months with sintilimab versus 8.25 (n = 135; 95% CI, 6.47-9.82) months with docetaxel (hazard ratio [HR]: 0.74; 95% CI, 0.56-0.96; P = 0.025). Sintilimab treatment significantly prolonged PFS (median 4.30 vs. 2.79 months; HR: 0.52; 95% CI, 0.39-0.68; P < 0.001) and showed higher ORR (25.50% vs. 2.20%, P < 0.001) and DCR (65.50% vs. 37.80%, P < 0.001) than the docetaxel arm. The median DoR was 12.45 (95% CI, 4.86-25.33) months in the sintilimab arm and 4.14 (95% CI, 1.41-7.23) months in the docetaxel arm (P = 0.045). Treatment-related adverse events of grade ≥ 3 were reported in 26 (18.1%) patients in the sintilimab arm and 47 (36.2%) patients in the docetaxel arm. Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors, including OVOL2 (HR: 0.35; P < 0.001) and CTCF (HR: 3.50; P < 0.001)，for sintilimab treatment.
conclusionsCompared with docetaxel, sintilimab significantly improved the OS, PFS, and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC.
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