Non-Small Cell Lung Cancer
Conditions
Keywords
Immunotherapy, Non-Small Cell Lung Cancer, hypofractionated radiotherapy
Brief summary
Patients with locally advanced NSCLC (Non-Small Cell Lung Cancer) who have a PD-L1 TPS ≥ 20% will be included in this study. It aims to explore the efficacy and safety of immunotherapy combined with hypofractionated concurrent chemoradiotherapy, followed by consolidation immunotherapy. Participants will undergo large fractionated radiotherapy with a total dose of 48Gy/16 fractions, 3Gy per fraction, 5 days a week. Participants will receive two cycles of concurrent platinum-based doublet chemotherapy and concurrent immunotherapy. Patients without progression will receive consolidation immunotherapy. The maximum duration of immunotherapy is 24 months.
Interventions
Immunotherapy combined with hypofractionated concurrent chemoradiotherapy followed by consolidation immunotherapy
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Sign a written informed consent before implementing any trial-related procedures. 2. Age ≥ 18 years and ≤ 70 years, male or female. 3. Histologically or cytologically confirmed inoperable locally advanced (IIB-IIIC) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Cancer 8th edition TNM lung cancer staging); Notes: 1. If EBUS/EUS or mediastinoscopy can safely obtain samples from the hilar or mediastinal lymph nodes, it is encouraged to obtain tissue for confirmation of involvement. When the lymph node boundary is clear and at least one lymph node has a short axis ≥ 2.0 cm, lymph node involvement can be determined by imaging (CT/MRI scan). For lymph nodes with a short axis \< 2.0 cm, if pathologically confirmed, the patient can be included in the study. If the primary tumor is deemed unresectable and mediastinal lymph node metastasis does not affect the radiotherapy plan, the patient can be included. 2. Determined and documented by a multidisciplinary tumor board or consultation with a thoracic surgeon: the patient has inoperable stage IIB-IIIC NSCLC. 4. No evidence of distant metastatic disease on diagnostic quality CT or MRI scans of the chest, abdomen, pelvis, and brain and/or whole-body fluorodeoxyglucose (FDG)-PET/CT, and classified as non-IV stage NSCLC (i.e., M0). Note: For pleural effusion present in both CT chest scan and frontal chest X-ray, a thoracentesis should be performed to confirm the pleural effusion is negative on cytology and is non-exudative. For patients who meet all other inclusion/
Exclusion criteria
but are unable to undergo thoracentesis due to minimal pleural effusion, they may still be included in the study. 5. Provide a sufficient amount of quality-controlled tumor tissue or cell wax blocks for the pathology department of the study center to test PD-L1 expression using the 22C3 antibody, with a PD-L1 TPS ≥ 20%; or a pre-screening PD-L1 TPS ≥ 20% result (regardless of the antibody used, including 22C3, SP263, SP142). 6. At least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for use as a target lesion. 7. No prior treatment for advanced/metastatic NSCLC (chemotherapy, targeted therapy, immunotherapy, or radiotherapy). Patients who have previously received systemic induction or neoadjuvant therapy (chemotherapy, immunotherapy) for stage IIB-IIIC NSCLC and are about to receive curative concurrent chemoradiotherapy can be included in the study. 8. Patients who have previously received induction immunotherapy can be included, including the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or drugs targeting another co-stimulatory or inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), immune LAG-3 inhibitors, and TIGIT monoclonal antibodies. 9. ECOG performance status of 0-1. 10. Life expectancy ≥ 6 months. 11. Adequate organ function, with the following laboratory parameters: 12. For women of childbearing potential, a negative urine or serum pregnancy test must be performed within 3 days prior to the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential women are defined as those who are at least 1 year post-menopausal, surgically sterilized, or have undergone a hysterectomy. 13. If there is a risk of pregnancy, all participants (regardless of sex) must use a contraceptive method with a failure rate of less than 1% during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | through study completion, an average of 3 years | From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | through study completion, an average of 3 years | The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) as their best overall response following treatment initiation, relative to the total number of subjects. |
| DOR | through study completion, an average of 3 years | Time interval from the first documented evidence of response (CR or PR) to disease progression or death (whichever occurs first). |
| OS | through study completion, an average of 3 years | Time from subject enrollment to death from any cause. |
| ORR | through study completion, an average of 3 years | The proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response following treatment initiation, relative to the total number of subjects. |
| Safety Evaluation | through study completion, an average of 3 years | Adverse events (AEs) occurring during the study and follow-up period will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Safety evaluation metrics include: Incidence, severity, and relationship to study treatment of all adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Number and proportion of subjects discontinuing treatment due to the above adverse events; |
| Economic Evaluation | through study completion, an average of 3 years | Cost-effectiveness of medical interventions will be assessed using metrics such as the Incremental Cost-Effectiveness Ratio (ICER) and Quality-Adjusted Life Years (QALYs). |
| HRQoL Assessment: | through study completion, an average of 3 years | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) will be used to evaluate subjects' global health status. |
Countries
China
Contacts
Primary ContactHuiming Yu
Backup ContactYue Teng
Outcome results
None listed