A Phase II, Randomised Study 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
Overview
- Phase
- Phase 2
- Intervention
- Neoadjuvant therapy
- Conditions
- Stage III Non-small-cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 264
- Locations
- 3
- Primary Endpoint
- Progression-free Survival
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Hui Liu
Prof
Sun Yat-sen University
Eligibility Criteria
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);
Exclusion Criteria
- •Exclusion criteria for enrolment for neoadjuvant therapy
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;
- •Mixed small cell and non-small cell lung cancer histology;
- •Current or prior use of immunosuppressive medication within 28 days before the first dose of Nivolumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
- •Prior exposure to any anti-programmed cell death protein(PD)-1 or anti-PD-L1 antibody;
- •Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of nivolumab;
- •Active or prior documented autoimmune disease within the past 2 years;
- •Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);
- •History of primary immunodeficiency;
Arms & Interventions
Nivolumab Consolidation
Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Neoadjuvant therapy
Nivolumab Consolidation
Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Chemotherapy concurrent with radiotherapy
Nivolumab Consolidation
Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Radiotherapy
Nivolumab Consolidation
Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Nivolumab
Observation
Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Neoadjuvant therapy
Observation
Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Chemotherapy concurrent with radiotherapy
Observation
Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Radiotherapy
Observation
Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
Intervention: Observation
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: 2 years
To assess the efficacy of Nivolumab consolidation compared with observation in terms of progression-free survival
Secondary Outcomes
- Overall Survival(2 years)
- Overall Survival(OS)(2 years)
- Objective Response Rate(ORR)(2 years)
- Adverse Event(2 years)
- Symptoms and Health-related Quality of Life(2 years)
- Progression-free Survival(2 years)