A Phase 2 interventional study of Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors in Non-Small Cell Lung Cancer, sponsored by Anhui Provincial Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Anhui Provincial Hospital · Phase 2, Interventional, and Treatment
The combination of immune checkpoint inhibitors (ICI) and local ablative radiotherapy has been demonstrated to be able to increase the survival of patients with metastatic driven-genes negative non-small cell lung cancer. Various dose-fraction of radiotherapy could exert different effects on the immune system. Ablative-dose could induce immunogenic cell death through the activation of CD8+(Cluster of Differentiation) T cells. Low-dose could modulate immune microenvironment from immunosuppression to inflammatory anti-tumor phenotype. This trial is designed to validation the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Trial Title: Hybrid dose-fraction Radiotherapy for metastatic driven-genes negative non-small cell lung cancer: A phase II multi-institutional study Trial Objective: To explore the safety and primary efficacy of the combination of hybrid dose-fraction radiotherapy with ICI for metastatic driven-genes negative non-small cell lung cancer patients.
Trial Design: This trial is designed to enroll 74 patients with metastatic driven-genes negative non-small cell lung cancer to receive the combination of hybrid dose-fraction radiotherapy with ICI.
Staging Examination before Radiotherapy: a. ECOG scoring. b. Cranial contrast MRI and PET-CT (Positron Emissions Tomography), or cranial contrast MRI (preferred), chest contrast CT, abdominal ultrasonography and bone scan. c. Bronchoscopy for centrally located lung cancer.
Inductive therapy ICI±chemotherapy for 4-6 cycles. Pembrolizumab and Tislelizumab are preferred. Chemotherapy regimens could be referred to NCCN (National Comprehensive Cancer Network) guidelines.
Restaging examination after inductive therapy is mandatory: a. ECOG scoring. b. Cranial contrast MRI, chest contrast CT, abdominal ultrasonography.
Patients with disease PR or SD (RECIST v1.1) evaluated by restaging after inductive therapy could be included into this trial. Patients would receive hybrid dose-fraction radiotherapy and ICI maintenance.
Radiotherapy CT Simulation: CT with intravenous contrast is recommended for simulation. Scan thickness should be less than 5 mm from lower margin of mandibular to lower margin of L2. For pulmonary lesions, 4D-CT (Four-Dimensional CT) localization is recommended.
Delineation of Targets:
For patients with oligometastasis, including synchronous oligometastatic disease \& metachronous oligorecurrence, all lesions should be prescribed with an ablative dose. The dose-fraction modalities are as following:
Thoracic lesions: 50Gy/5f (50 Gray/5 fractions), 60Gy/8f, 60Gy/15f, 48Gy/12f. Intracranial lesions: 30Gy/10f (Whole Brain Irradiation), 30Gy/3f, 30Gy/5f, 45Gy/15f.
Hepatic lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Adrenal lesions: 50Gy/5f, 40Gy/5f, 32Gy/4f. Osseous lesions: 27Gy/3f, 40Gy/5f, 30Gy/5f, 39Gy/13f. Other lesions: Refer to the above dose-fraction. For patients with systemic metastasis, high-dose should be prescribed to 1-3 lesions (longest diameter>1cm). All of the remaining lesions should be given low-dose. High-dose includes 24-40Gy/3-5f. Low-dose includes 6-15Gy/4-10f.
The Planning Target Volume (PTV) was defined as an 8-mm margin of the GTV (Gross Tumor Volumn) for tumor motion and set-up variations.
The delivery of ablative dose and high-dose should utilize the technology of SABR (Stereotactic Ablative Body Radiotherapy).
Dosimetric Limitation of Organ at Risk: 95% prescription dose should cover 100% PTV and 95% PTV should receive 100% prescription dose.
The dose constraints of organs at risk could refer to TG 101 (Task Group 101) report.
Treatment Implementation: Radiotherapy is implemented every day. Cone-beam CT should be utilized every day to minimize set-up error.
Follow-up: Patients should be follow-up every three months right after the completion of radiotherapy to disease progression.
Primary Endpoint: Progress-free Survival (PFS).
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 78 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Anhui Provincial Hospital is the lead sponsor of 129 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Patients in this arm would receive hybrid dose-fraction radiotherapy combined with immune checkpoint inhibitors.
Drug: Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
Hybrid dose-fraction Radiotherapy combined with immune checkpoint inhibitors
Also known as: no other interventions
Progression-free Survival
Progression-free Survival evaluated by RECIST (v1.1)
Time frame: 1-year
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Anhui Provincial Hospital