A Phase 3 interventional study of Reduced-Dose Thoracic Radiotherapy and Standard-Dose Thoracic Radiotherapy in Non-Small-Cell Lung Cancer, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Ruijin Hospital · Phase 3, Interventional, and Treatment
This is a multicenter, open-label, randomized phase III study in older or frail adults with unresectable stage III non-small cell lung cancer (NSCLC) who are considered unsuitable for concurrent chemoradiotherapy. All participants first receive standard induction chemotherapy plus immunotherapy (4-6 cycles), which is part of routine clinical care and not a study intervention. Patients whose cancer responds (complete response, partial response, or stable disease) may then sign informed consent and be randomly assigned 1:1 to receive either reduced-dose thoracic radiotherapy or standard-dose thoracic radiotherapy. After radiotherapy, both groups receive immune checkpoint inhibitor maintenance therapy for at least 6 months.
The main goal is to find out whether reduced-dose radiotherapy is not unacceptably worse than standard-dose radiotherapy in controlling the cancer at 1 year, measured by the 1-year progression-free survival rate. The study will also compare side effects, overall survival, tumor response, and treatment completion. About 276 patients will be enrolled at Ruijin Hospital and six collaborating hospitals in China.
6,666 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,682 are open to participants now.
This study's planned enrollment of 276 is above the median of 62 across 5,345 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Ruijin Hospital is the lead sponsor of 674 studies on the registry; 382 are open to participants now.
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Exclusion Criteria:
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of Complete Response(CR)/Partial Response(PR)/Stable Disease(SD), participants are randomized to reduced-dose thoracic radiotherapy(RT): 50-54 Gy in 25-27 fractions (2.0 Gy/fraction, 5 fractions/week, about 5 weeks), without concurrent immune checkpoint inhibitor (ICI). After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death.
Radiation: Reduced-Dose Thoracic Radiotherapy
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of CR/PR/SD, participants are randomized to standard-dose thoracic radiotherapy: 60-66 Gy in 30-33 fractions (2.0 Gy/fraction, 5 fractions/week, about 6 weeks), without concurrent immune checkpoint inhibitor (ICI). After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death.
Radiation: Standard-Dose Thoracic Radiotherapy
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of CR/PR/SD by RECIST 1.1, participants receive thoracic radiotherapy to the involved tumor and metastatic lymph nodes using IMRT/VMAT. The prescribed dose is 50-54 Gy in 25-27 fractions (2.0 Gy/fraction, 5 fractions/week, about 5 weeks). No concurrent immune checkpoint inhibitor (ICI) is given during radiotherapy. After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death. This arm is distinguished from the comparator by the lower radiation dose and fewer fractions.
Also known as: Reduced-dose thoracic RT
After 4-6 cycles of standard induction chemotherapy plus immunotherapy and confirmation of CR/PR/SD by RECIST 1.1, participants receive thoracic radiotherapy to the involved tumor and metastatic lymph nodes using IMRT/VMAT. The prescribed dose is 60-66 Gy in 30-33 fractions (2.0 Gy/fraction, 5 fractions/week, about 6 weeks). No concurrent immune checkpoint inhibitor (ICI) is given during radiotherapy. After radiotherapy, participants receive ICI maintenance therapy for at least 6 months (8 cycles) or until disease progression, unacceptable toxicity, or death. This arm is distinguished from the experimental arm by the higher standard radiation dose and more fractions.
1-Year Progression-Free Survival (PFS) rate
Proportion of participants who are alive and free of disease progression at 1 year after randomization. Disease progression is assessed by investigators according to RECIST 1.1 using CT/MRI/PET-CT, with imaging performed every 2-3 months after randomization. The primary analysis will be performed in the intention-to-treat (ITT) population. The study will test noninferiority of reduced-dose thoracic radiotherapy versus standard-dose thoracic radiotherapy, with a noninferiority margin of 15% absolute difference in the 1-year PFS rate. Noninferiority will be concluded if the lower limit of the one-sided 97.5% confidence interval for the difference (reduced-dose minus standard-dose) is greater than -15%.
Time frame: 1 year after randomization
2-year Progression-Free Survival (PFS)
Proportion of participants who are alive and free of disease progression at 2 years after randomization. Disease progression is assessed according to RECIST 1.1. The 2-year PFS rate will be estimated using the Kaplan-Meier method in the intention-to-treat (ITT) population.
Time frame: 2 years after randomization (or until disease progression, death, or end of follow-up, whichever occurs first).
Overall Survival
Time from randomization to death from any cause. Participants alive at the last follow-up will be censored. Estimated using the Kaplan-Meier method in the ITT population.
Time frame: From randomization until death or end of study follow-up
Objective Response Rate (ORR)
Proportion of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. Assessed in the ITT population(assessed every 2-3 months; approximately 12-18 months per participant).
Time frame: From randomization through the treatment and follow-up period (assessed every 2-3 months; approximately 12-18 months per participant).
Incidence of Grade ≥3 Adverse Events (AEs)
Proportion of participants experiencing at least one grade ≥3 adverse event, graded according to NCI-CTCAE v5.0 (early AEs) and RTOG late toxicity criteria (late AEs). Assessed in the safety set.
Time frame: From randomization through radiotherapy and ICI maintenance, and during follow-up (approximately 18 months per participant).
Treatment Discontinuation Rate
Proportion of participants who discontinue radiotherapy or ICI maintenance early for any reason. Assessed in the ITT population.
Time frame: From randomization through completion of radiotherapy and ICI maintenance (approximately 12 months per participant).
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared. The study protocol and informed consent documents do not include authorization for public deposition of participant-level data; sharing IPD could compromise participant privacy and confidentiality, particularly given the small number of participating centers and the identifiable nature of clinical, imaging, and treatment data. In addition, data ownership and sharing arrangements among the multicenter collaborators have not been established, and no formal data-sharing platform or infrastructure is planned. Study results will instead be reported in aggregate through peer-reviewed publications and trial registry summaries, in accordance with journal and regulatory requirements.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.
Of 94 non-industry phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 54 and three quarters within 129. This study's planned 50 months is below that.
Counting every sponsor, half of 395 studies reached it within 44 months; a quarter within 30 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →