Stage III Non-small-cell Lung Cancer
Conditions
Keywords
Stage III Non-Small Cell Lung Cancer, Neoadjuvant Chemotherapy plus nivolumab, Chemoradiotherapy, Nivolumab consolidation
Brief summary
The phase II, randomised Study is to explore the efficacy and safety of nivolumab as consolidation therapy in patients with locally advanced, unresectable non-small cell lung cancer (stage III) who have not progressed following neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy
Interventions
OTHERNeoadjuvant therapy
The neoadjuvant therapy before radiotherapy comprised of Docetaxel 60 mg/m2 for 1 hour + Cisplatin 75 mg/m2+Nivolumab 360 mg, once every 3 weeks (Q3W), for a total of 2 cycles.
OTHERChemotherapy concurrent with radiotherapy
Docetaxel 25 mg/m2 for 1 hour +Cisplatin 25 mg/m2, once a week (QW)
RADIATIONRadiotherapy
Hypofractionated radiation technique was used to deliver a definitive radiation dose
DRUGNivolumab
Nivolumab consolidation (360 mg) via iv infusion once every 3 weeks (Q3W)±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy. Administration of nivolumab will commence on Day 1 following randomisation to Nivolumab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 12 months.
OTHERObservation
Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* For inclusion in neoadjuvant therapy, patients should fulfil the following criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures； * Male or female aged 18\ 75 years old； * Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease; * Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy; * Tumour sample requirements: Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow for analysis; * A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk; * Life expectancy ≥12 weeks; * World Health Organization (WHO) Performance Status of 0 or 1; * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent); * Women must be non-breastfeeding * Women of reproductive age (WOCBP) must agree to comply with the contraceptive method during the study nivolumab treatment and for a period of 5 months following the last administration of the study treatment (i.e., 30 days \[ovulation cycle\] plus approximately 5 half-lives of the study drug). * Men who have sex with WOCBP must agree to comply with the contraceptive method during the study nivolumab treatment and for 7 months after the last administration of the study treatment (i.e. 90 days \[sperm renewal cycle\] plus approximately 5 half-life of the study drug). * Spermless men do not have to comply with contraceptive requirements. WOCBP who continues to be asexual with the opposite sex does not have to comply with contraceptive requirements, but must still undergo the pregnancy tests described in this section. * Adequate organ and marrow function as defined below: * Forced expiratory volume in 1 second (FEV1) ≥800ml * Absolute neutrophil count \>1.5 x 109/L (1500 per mm3) * Platelets \>100 x 109/L (100,000 per mm3) * Haemoglobin≥9.0 g/dL (5.59 mmol/L) * Serum creatinine clearance(CL) \>50 mL/min by the Cockcroft-Gault formula (Cockcroft and -Gault 1976) * Serum bilirubin ≤1.5 x upper limit of normal (ULN). ··Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 2 years | To assess the efficacy of Nivolumab consolidation compared with observation in terms of progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate(ORR) | 2 years | To assess the efficacy of Nivolumab consolidation compared with observation in terms of Objective Response Rate; To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of objective response rate after neoadjuvant therapy |
| Adverse Event | 2 years | To assess the safety of Nivolumab consolidation compared with observation in terms of adverse event |
| Overall Survival(OS) | 2 years | To assess the efficacy of Nivolumab consolidation compared with observation in terms of Overall survival |
| Progression-free Survival | 2 years | To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of progression-free survival for all patients |
| Overall Survival | 2 years | To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of overall survival for all patients |
| Symptoms and Health-related Quality of Life | 2 years | To assess the symptoms and health-related quality of life in patients treated with Nivolumab consolidation compared with observation |
Countries
China
Outcome results
None listed