limited stage small cell lung carcinoma
Conditions
Interventions
After enrolment, the patient will receive standard of care treatment for
limited-stage small cell lung cancer, consisting of:
* Chemotherapy: will be started in the week following enrolment (alternat
ipilimumab
limited-stage disease
nivolumab
small cell lung cancer
Sponsors
European Thoracic Oncology Platform (ETOP)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: At enrolment: * histologically or cytologically confirmed small cell lung carcinoma * untreated limited stage disease (with the exception of one cycle of chemotherapy given prior enrolment) as defined by stage I-IIIB based on 7th TNM classification (IASLC classification for small cell lung cancer proposal). M0 proven by a) 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 b) brain MRI (or contrast enhanced CT of the brain). * within 28 days before start of chemotherapy * age * 18 years * ECOG performance status 0-1 * adequate haematological, renal, hepatic and lung function * pulmonary function FEV1 of 1.0 L or > 40% predicted value and DLco > 40% predicted value;At randomisation: * chemo-radiotherapy completed per protocol: 4 cycles of chemotherapy, 85% of planning target volume of thoracic radiotherapy, as well as completed, mandatory prophylactic cranial irradiation (PCI) * non-progressive disease after chemo-radiotherapy and PCI
Exclusion criteria
Exclusion criteria: At enrolment: * patient with mixed small-cell and non-small-cell histologic features * patient with pleural or pericardial effusions proven to be malignant * documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (e.g. steroids) treatment such as ulcerative colitis and Crohn*s disease, rheumathoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener*s granulomatosis) *Subjects with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment. * 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 (if no radiotherapy was involved). * previous radiotherapy to the thorax (prior to inclusion), including radiotherapy for breast cancer * planned mean lung dose > 20 Gy or V20 > 35 %
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of this study are the progression-free survival as assessed by RECIST 1.1(time from date of randomisation until documented progression of death, if progression is not documented) and the overall survival (time from date of randomisation until death from any cause) of the patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: * Objective response (best overall response across all assessment time-points from randomisation to termination of trial treatment) determined by RECIST 1.1 * Time to treatment failure (time from date of randomisation to discontinuation of treatment for any reason) * Adverse events graded according to CTCAE v 4.0. | — |
Countries
Belgium, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed