Non-small Cell Lung Cancer Stage III
Conditions
Keywords
thoradic radiotherapy, non-small-cell lung cancer, chemo-immunotherapy, survival
Brief summary
Concurrent chemoradiotherapy without disease progression followed by consolidation durvalumab is standard of care for unresectable, stage III non-small-cell lung cancer (NSCLC) (the 'PACIFIC regimen'). However, many patients with poor performance status, older age or comorbidities may be ineligible for chemotherapy due to expected high toxicity. The present study aim to investigate the efficacy and toxicities of sequential chemo-immunotherapy plus thoracic radiotherapy for elderly and/or frail stage III NSCLC patients unfit for concurrent chemoradiotherapy, and to identify the optimal thoracic dose for this patient population.
Interventions
RADIATIONstandar thoracic RT dose
All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with standard dose thoracic radiotherapy of 60 Gy/30Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
RADIATIONdecreased thoracic RT dose
All the enrolled patients will be patients with NSCLC who did not have PD (determined as per the RECIST v1.1) after 4-6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with decreased thoracic radiotherapy of 50Gy/25Fx concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at time of study entry 2. Histologically documented diagnosis of unresectable stage III NSCLC; 3. Fully-informed written consent obtained from patients; 4. Unfit for concurrent chemoradiotherapy as determined by the multi-disciplinary team board due to one of the following reasons: (1) ECOG 2; (2)age≥70;(3) ECOG 1 and CCI≥1； 5. Adequate bone marrow, liver and kidney function 6. Life expectancy of at least 3 months 7. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated 8. Histologic or cytologic confirmation of small cell lung cancer 9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
Exclusion criteria
1. Previous chemo-, immuno- or radiotherapy for NSCLC 2. Major surgical procedure last 28 days 3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV 4. Uncontrolled intercurrent illness 5. Other active malignancy 6. Leptomeningeal carcinomatosis 7. Immunosuppressive medication 8. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 12 months after last patient entry | time from treatment start until death or progression of tumor disease within one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survial | 12 months after last patient entry | time from treatment start until death with in one year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 within one year | 12 months after last patient entry | Safety and Tolerability |
| 5-year overall survival | 5-years after last patient entry | Time from treatment start until death |
Countries
China
Outcome results
None listed