Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
Patients with stage III non-small-cell lung cancer (NSCLC) who receive neoadjuvant chemoimmunotherapy may achieve good response in the primary tumor but still have residual nodal disease after surgery (ypTanyN⁺M0), which is associated with poor prognosis in retrospective analyses from our center. In prior trials such as LungART and PORT-C, postoperative radiotherapy (PORT) did not improve disease-free survival in completely resected stage IIIA-N2 NSCLC after adjuvant chemotherapy, suggesting that PORT should not be used indiscriminately. However, recent preclinical and translational data indicate that radiotherapy can enhance antitumor immunity, remodel the tumor microenvironment, and synergize with immune checkpoint inhibitors via immunogenic cell death, improved T-cell trafficking, and tertiary lymphoid structure formation.
This single-center randomized phase II study will evaluate whether adding postoperative involved-field nodal radiotherapy to standard PD-1 maintenance therapy can improve disease-free survival compared with PD-1 maintenance alone in patients with ypTanyN⁺M0 NSCLC after neoadjuvant chemoimmunotherapy and R0 resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, male or female.
Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, or other NSCLC subtypes).
Clinical stage IIIA/IIIB at initial diagnosis, deemed suitable for neoadjuvant chemoimmunotherapy followed by surgery according to MDT.
Completed 2-4 cycles of platinum-based doublet chemotherapy plus PD-1 inhibitor as neoadjuvant therapy.
Disqualifiers
Positive surgical margins (R1 or R2) or incomplete resection.
Prior thoracic radiotherapy that would overlap with planned treatment fields.
Active, uncontrolled infection or unresolved ≥ Grade 2 immune-related adverse events.
History of severe autoimmune disease requiring systemic immunosuppression.
Trial design
Design model
Parallel
Treatments tested in this trial
radiotherapy
RadiationPostoperative external beam radiotherapy to regional draining lymph nodes (e.g., ipsilateral mediastinal and hilar nodal stations involved or at high risk), based on pre-treatment imaging and surgical/pathologic findings. Suggested dose: 50-54 Gy in 25-27 fractions (2.0-2.16 Gy per fraction, once daily, 5 days per week), delivered with 3D-CRT or IMRT per institutional standards.
PD -1/PD-L1 monoclonal antibody
DrugAnti-PD-1 monoclonal antibody administered intravenously every 3 weeks for up to 1 year (or until disease recurrence, unacceptable toxicity, or withdrawal). The specific agent and dose will follow the neoadjuvant regimen and local regulatory approval.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: Involved-field radiotherapy to regional draining lymph nodes + PD-1 maintenanceActive comparator 2 interventions
Group B: No radiotherapy (standard of care) + PD-1 maintenanceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Disease-Free Survival (DFS)
Time from date of surgery to first documented recurrence (locoregional or distant) or death from any cause, whichever occurs first.
Time frame
3 yearsSecondary outcomes
1
Overall Survival (OS)
Time from surgery to death from any cause (up to 5 years).
Time frame
5 years2
Incidence of Treatment-Emergent Adverse Events
Incidence, type, and severity of adverse events graded by CTCAE v5.0, including radiation pneumonitis and immune-related toxicities.
Time frame
Through treatment completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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