Non-small cell lung cancer
Conditions
Interventions
Experimental group:LATTICE radiotherapy combined with immunotherapy
Sponsors
Hangzhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically or pathologically confirmed NSCLC; 2.Stage IV disease according to AJCC 9th edition Lung Cancer Staging, or unresectable/unfit for definitive chemoradiation Stage IIIB/IIIC disease (e.g., bilateral lung involvement); 3.Absence of driver gene alterations (including, but not limited to, EGFR/BRAF V600E mutations, ALK/ROS1/RET fusions); 4.Achieved Partial Response (PR) or Stable Disease (SD) after receiving >=4 cycles of first-line therapy with Immune Checkpoint Inhibitors (ICIs) combined with platinum-based doublet chemotherapy; 5.Presence of a bulky lesion (primary or metastatic) with a maximum diameter >5 cm that has not received prior local therapy and is confirmed via multidisciplinary evaluation to be suitable for safe implementation of the LATTICE technique; 6.Age >=18 years; 7.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (confirmed within 7 days prior to the first dose); 8.Life expectancy >=6 months; 9.Male participants: Must agree to use effective contraception and refrain from sperm donation from the start of treatment until 180 days after the last dose; 10.Female participants must not be pregnant or lactating and must meet at least one of the following criteria: a. Not of childbearing potential, OR b. Agree to use effective contraception from the start of treatment as specified in the protocol; 11.Signed informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with locally advanced NSCLC amenable to curative-intent concurrent chemoradiation or surgery (Stage IIIB/IIIC per AJCC 9th edition Lung Cancer Staging); 2.The target lesion intended for LATTICE radiotherapy has received prior local therapy (e.g., radiotherapy, radiofrequency ablation, particle implantation); 3.Presence of unresolved prior treatment-related toxicities of Grade >=2 (except for alopecia, fatigue, and endocrinopathies stabilized with hormone replacement therapy); 4.Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years (local steroid use or physiologic replacement therapy is allowed); 5.Current or history of Grade >=2 immune-related pneumonitis/interstitial lung disease requiring corticosteroid treatment; 6.History of immunodeficiency diseases, such as immunoglobulin deficiency, aplastic anemia, human immunodeficiency virus (HIV) infection, etc; 7.Active hepatitis B (defined as HBV DNA > 500 copies/mL) or hepatitis C virus (defined as HCV RNA positive) infection; 8.Active tuberculosis (untreated or treated for less than 4 weeks); 9.Administration of a live or attenuated live vaccine within 30 days prior to the first study intervention. Inactivated vaccines are allowed; 10.Other progressive malignancies within 5 years (except for curatively treated skin carcinoma/carcinoma in situ of the cervix, or solid tumors with no recurrence for >3 years after radical surgery); 11.Uncontrolled central nervous system metastases (patients with asymptomatic/stable lesions for >=4 weeks not requiring corticosteroids are eligible); 12.History of Grade >=3 hypersensitivity to PD-1/PD-L1 inhibitors or platinum-based chemotherapy; 13.Active infection requiring systemic therapy; 14.Any medical condition that, in the investigator's judgment, poses an excessive risk to the patient, such as poorly controlled diabetes, liver failure, or cardiac dysfunction; 15.Uncontrolled psychiatric illness or substance dependence (interfering with treatment or informed consent); 16.Pregnancy, lactation, or refusal to use contraception; 17.History of allogeneic tissue or solid organ transplantation; 18.Patients unable to comply with regular follow-up; 19.Currently participating in or have received other investigational drugs or devices;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the progression-free survival (PFS) of LATTICE radiotherapy combined with ICIs in the treatment of advanced large-mass NSCLC; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the overall, in?field, and out?of?field disease control rate (DCR) of LATTICE radiotherapy combined with immune checkpoint inhibitors (ICIs) in the treatment of advanced bulky non?small ce;To evaluate the overall survival (OS) of LATTICE radiotherapy combined with ICIs in the treatment of advanced large-mass NSCLC;Safety endpoint;To evaluate the overall, in-field and field objective response rates (ORR) of LATTICE radiotherapy combined with ICIs in the treatment of advanced large-mass NSCLC; | — |
Countries
China
Contacts
Public ContactKan Wu
Hangzhou Cancer Hospital
Outcome results
None listed