None listed
Conditions
Brief summary
The aim of the current study is to investigate whether adding nivolumab and ipilimumab after chemoradiotherapy helps to stop small cell lung cancer coming back. You may be eligible for this study if you are an adult with confirmed small cell lung carcinoma. If the study is suitable for you, you will commence treatment with chemotherapy and thoracic (chest) radiotherapy and prophylactic cranial irradiation (PCI/ brain) radiotherapy which are the standard of care treatment for SCLC. Following completion of the chemotherapy and radiotherapy part of your treatment you will have a CT scan to see if your cancer is shrinking or growing. If your cancer has grown your consulting doctor will discuss the most suitable treatment for you at that time. If your cancer has not grown, you will go on to the next part of the study, and you will be randomised into one of two study groups: Group 1: Nivolumab plus ipilimumab (experimental treatment) Group 2: Observation (no further treatment) If you take part in STIMULI, you will have a number of tests at the first study visit to confirm that the study is suitable for you. At each study visit, you will have various assessments, such as blood testing, urine testing. Computerised Tomography (CT) scans to assess your cancer will be performed every 2-3 months for the first 2 years and then less frequently. This study will help researchers understand how well this treatment works and how severe the side effects are of the standard treatment (chemotherapy and radiotherapy) alone, compared with the standard treatment (chemotherapy and radiotherapy) followed by immunotherapy (nivolumab and ipilimumab) in patients with limited SCLC.
Interventions
During the induction phase patients will receive nivolumab at a dose of 1 mg/kg intravenously followed (on the same day) by ipilimumab at a dose of 3 mg/kg intravenously once every 3 weeks for 4 cycles. This is followed by the maintenance phase. During this phase patients will receive nivolumab 240 mg intravenously once every 2 weeks for a maximum of 12 months from start of maintenance phase (no minimum time for the maintenance phase).
Sponsors
NHMRC Clinical Trials Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At enrolment: -Histologically or cytologically confirmed small cell lung carcinoma -Untreated (with the exception of 1 cycle of chemotherapy given prior to enrolment) limited stage disease (LD) as defined by stage I-IIIB based on 7th TNM classifica-tion (IASLC classification for SCLC proposal). M0 proven by -Whole body FDG-PET CT including a contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals); OR contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals) and bone scan; AND -Brain MRI (or contrast enhanced CT of the brain). Within 28 days before start of chemotherapy -Age greater than or equal to 18 years -ECOG performance status 0-1 -Adequate haematological, renal, hepatic and lung function -Pulmonary function FEV1 of 1.0L or greater than 40% predicted value and DLCO greater than 40% predicted value At randomisation: -Chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, 85% of PTV of thoracic radiotherapy, as well as completed, mandatory PCI -Non-PD after chemo-radiotherapy and PCI
Exclusion criteria
Exclusion criteria at enrolment: -Patients with mixed small-cell and non-small-cell histologic features -Patients with pleural or pericardial effusions proven to be malignant -Documented history of severe autoimmune or immune mediated symptomatic dis-ease that required prolonged (more than 2 months) systemic immunosuppressive treatment (e.g steroids) such as ulcerative colitis and Crohn´s disease, rheumathoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythemato-sus, or autoimmune vasculitis (eg, Wegener’s granulomatosis) -Patients with an autoimmune paraneoplastic syndrome requiring concurrent immu-nosuppressive treatment are excluded. -Interstitial lung disease or pulmonary fibrosis -Women who are pregnant or in the period of lactation -Patients with any concurrent anticancer systemic therapy (except for chemotherapy cycle 1) -HIV, Hepatitis B or Hepatitis C infection -Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast. -Previous radiotherapy to the thorax (prior to inclusion) -Planned mean lung dose greater than 20 Gy or V20 greater than 35%
Outcome results
None listed