ArticleBMJ open2025
Low-dose radiation and stereotactic body radiotherapy with PD-1 inhibitor sintilimab and chemotherapy for first-line treatment of locally advanced or metastatic squamous lung cancer: protocol for a randomised phase II trial (IHC002 study).
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06121505 (Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer), which is not on this map. Cited by 5 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.
Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial
Who cites it
5 citing papers in PubMed.
- Heterogeneous Radioimmunotherapy for Bulky Tumors: A Phase 1 Trial for Advanced Non-Small Cell Lung Cancer.Advances in radiation oncology · 2026Article
- Tumor-Regional Immune Microenvironment: A Critical Factor in the Design of Radiotherapy-Immunotherapy Combination Trials.International journal of cancer · 2026Review
- Low-dose radiotherapy as an immunomodulator in cancer: dose-specific mechanisms and hybrid high-dose/low-dose strategies.Biomarker research · 2026Review
- Low-dose radiotherapy synergizes with PD-1 blockade to achieve durable survival in advanced NSCLC through antitumor neutrophil programming.Signal transduction and targeted therapy · 2026Article
- Immune-tumor cell ligand-receptor axes driving metabolic reprogramming and therapeutic resistance in cancer.Frontiers in immunology · 2026Review
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Authors and funding
4 authors.
Funding
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Abstract
introductionLung cancer remains a leading cause of cancer-related deaths worldwide, with squamous lung cancer representing a significant subtype. Despite advancements in chemotherapy and immunotherapy, outcomes for patients with advanced squamous lung cancer remain suboptimal. Recent studies have shown that immunotherapy, particularly with programmed death receptor 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors, can improve survival rates, but challenges persist in achieving durable responses. Combining immunotherapy with radiotherapy has emerged as a promising strategy. Stereotactic body radiotherapy (SBRT) can enhance the immune response by inducing tumour-specific antigen release and promoting systemic immune activation, while low-dose radiation (LDRT) may further potentiate these effects by modulating the immune environment. This study explores a novel triple-combination approach using SBRT, LDRT, sintilimab and chemotherapy to optimise therapeutic efficacy and improve outcomes in locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). METHODS AND ANALYSIS: This is a randomised, controlled, open-label, multicentre phase II clinical trial involving patients with locally advanced or metastatic sqNSCLC. Participants are randomised 1:1 into two arms: the experimental arm receives SBRT and LDRT combined with sintilimab and chemotherapy, while the control arm receives sintilimab with chemotherapy alone. Randomisation is stratified by PD-L1 expression and the presence of brain metastases. The primary endpoint is the objective response rate. Secondary endpoints include disease control rate, progression-free survival, overall survival and safety. Based on an expected ORR of 75% for the experimental group and 55% for the control, with a 20% difference detection at 80.1% power and a two-sided α level of 0.2, a total of 114 patients (57 per group, accounting for a 10% dropout rate) is required. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Commission of Sichuan University West China Hospital (2023-1582), Medical Ethics Committee of Affiliated Hospital of North Sichuan Medical College (2024ER543-1), Ethics Committee of The Second Affiliated Hospital of Chongqing Medical University (2024-54-2), Ethics Committee of Union Hospital (Tongji Medical College, Huazhong University of Science and Technology) (2024-1052-02), Ethics Committee of Sichuan Cancer Hospital (SCCHEC-02-2025-069), Clinical Trial Ethics Committee of Deyang People's Hospital (2025-03-012-H01), and Ethics Committee of Guizhou Provincial People's Hospital (2025-108). Results will be submitted for publication in a peer-reviewed journal.
trial registrationNCT06121505.
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