Non-Small-Cell Lung CancerPhase 3NCT07908745
Reduced-Dose vs Standard-Dose Thoracic Radiotherapy After Induction Chemoimmunotherapy in Older or Frail Stage III NSCLC
A Phase 3 study testing Reduced-Dose Thoracic Radiotherapy and Standard-Dose Thoracic Radiotherapy in people with Non-Small-Cell Lung Cancer, run by Ruijin Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Reduced-Dose Thoracic Radiotherapy and Standard-Dose Thoracic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 3 Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unresectable stage III non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
- For non-squamous NSCLC: known EGFR-sensitizing mutations must be excluded.
- Considered unsuitable for concurrent chemoradiotherapy by a multidisciplinary team, meeting at least one of the following: ECOG performance status 2; or Age ≥70 years; or Age 65-69 years with Charlson Comorbidity Index (CCI) ≥1; or Age 60-64 years with CCI ≥2.
- Adequate bone marrow, hepatic, and renal function.
- Expected survival of at least 3 months.
- At least one measurable (RECIST 1.1) and irradiable thoracic lesion.
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- Adequate pulmonary function: FEV1 >1 L or >50% of predicted, and DLCO >60% of predicted.
- Completion of 4-6 cycles of induction chemotherapy plus immunotherapy.
- Post-induction response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
- Willingness to receive thoracic radiotherapy followed by sequential immune checkpoint inhibitor (ICI) maintenance therapy.
- Provision of written informed consent.
Who cannot join
- Prior chemotherapy, immunotherapy, or radiotherapy for NSCLC.
- Major surgery within the past 28 days.
- History of allogeneic organ transplantation, autoimmune disease, immunodeficiency, hepatitis, or HIV infection.
- Uncontrolled comorbid conditions.
- Other active malignancy.
- Leptomeningeal carcinomatosis.
- Contraindication to the use of immunosuppressive drugs.
- Pregnancy or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reduced-Dose Versus Standard-Dose Thoracic Radiotherapy After Induction Chemo-Immunotherapy in Older/Frail Patients With Locally Advanced Non-Small Cell Lung Cancer: An Open-Label, Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial
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.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Reduced-Dose Thoracic Radiotherapy, Standard-Dose Thoracic Radiotherapy
- Keywords
- Older adults, Frail patients, Non-Small Cell Lung Cancer, Induction Chemo-Immunotherapy, Reduced-Dose Thoracic Radiotherapy, Noninferiority Randomized Controlled Trial, Sequential Chemoradiotherapy, Immune Checkpoint Inhibitor Maintenance
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced-Dose Thoracic RadiotherapyRadiation
Also called 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 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.
Standard-Dose Thoracic RadiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Reduced-Dose Thoracic Radiotherapy | Experimental | 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. Receives: Radiation: Reduced-Dose Thoracic Radiotherapy |
| Standard-Dose Thoracic Radiotherapy | Active comparator | 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. Receives: Radiation: Standard-Dose Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 1 year after randomization
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From randomization through completion of radiotherapy and ICI maintenance (approximately 12 months per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion3 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baotou Cancer Hospital, The First Affiliated Hospital of Qiqihar Medical University, Linfen No.4 People's Hospital, Qianxinan Prefecture People's Hospital, Guizhou, Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital, Qinghai People's Hospital
- Responsible party
- Principal investigator, QI WEIXIANG，MD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908745
- Sponsor's protocol ID
- 2026-831
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-Dose Versus Standard-Dose Thoracic Radiotherapy After Induction Chemo-Immunotherapy in Older/Frail Patients With Locally Advanced Non-Small Cell Lung Cancer: An Open-Label, Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07908745
- Acronym / sponsor ID
- 2026-831
- Conditions
- Non-Small-Cell Lung Cancer
- Keywords
- Older adults, Frail patients, Non-Small Cell Lung Cancer, Induction Chemo-Immunotherapy, Reduced-Dose Thoracic Radiotherapy, Noninferiority Randomized Controlled Trial, Sequential Chemoradiotherapy, Immune Checkpoint Inhibitor Maintenance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Baotou Cancer Hospital, The First Affiliated Hospital of Qiqihar Medical University, Linfen No.4 People's Hospital, Qianxinan Prefecture People's Hospital, Guizhou, Qiandongnan Miao and Dong Autonomous Prefecture People's Hospital, Qinghai People's Hospital
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 3 Dec 2031 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced-Dose Thoracic Radiotherapy | Experimental | Radiation: Reduced-Dose Thoracic RadiotherapyAfter 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. |
| Standard-Dose Thoracic Radiotherapy | Active comparator | Radiation: Standard-Dose Thoracic RadiotherapyAfter 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed unresectable stage III non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
- For non-squamous NSCLC: known EGFR-sensitizing mutations must be excluded.
- Considered unsuitable for concurrent chemoradiotherapy by a multidisciplinary team, meeting at least one of the following: ECOG performance status 2; or Age ≥70 years; or Age 65-69 years with Charlson Comorbidity Index (CCI) ≥1; or Age 60-64 years with CCI ≥2.
- Adequate bone marrow, hepatic, and renal function.
- Expected survival of at least 3 months.
Key exclusion criteria (8 listed)
- Prior chemotherapy, immunotherapy, or radiotherapy for NSCLC.
- Major surgery within the past 28 days.
- History of allogeneic organ transplantation, autoimmune disease, immunodeficiency, hepatitis, or HIV infection.
- Uncontrolled comorbid conditions.
- Other active malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced-Dose Thoracic RadiotherapyAlso: Reduced-dose thoracic RTAfter 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. | Radiation | Reduced-Dose Thoracic Radiotherapy |
| Standard-Dose Thoracic RadiotherapyAfter 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. | Radiation | Standard-Dose Thoracic Radiotherapy |
Primary outcome
1-Year Progression-Free Survival (PFS) rate
Time frame: 1 year after randomization
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%.
5 secondary outcomes
2-year Progression-Free Survival (PFS)
Time frame: 2 years after randomization (or until disease progression, death, or end of follow-up, whichever occurs first).
Overall Survival
Time frame: From randomization until death or end of study follow-up
Objective Response Rate (ORR)
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)
Time frame: From randomization through radiotherapy and ICI maintenance, and during follow-up (approximately 18 months per participant).
Treatment Discontinuation Rate
Time frame: From randomization through completion of radiotherapy and ICI maintenance (approximately 12 months per participant).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reduced-Dose Thoracic Radiotherapy and Standard-Dose Thoracic Radiotherapy in people with Non-Small-Cell Lung Cancer, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weixiang Qi, Dr. (+86-021-64370045, qiweixiang1113@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Progression-Free Survival (PFS) rate (time frame: 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.