Some patients with limited disease small-cell lung cancer (LD SCLC) are cured after chemo-radiotherapy, but the majority relapse and die from their cancer. Better therapy is needed. Immunotherapy represents the largest advance in cancer therapy in recent years and has demonstrated promising activity in SCLC. In this study we will investigate whether atezolizumab prolongs survival in LD SCLC patients who have undergone chemo-radiotherapy.
Patients who have * completed 4 course of platinum/etoposide and thoracic radiotherapy of 45 Gy/30 fractions, 2 fractions per day * non-progression after chemo-radiotherapy * ECOG performance status 0-2 will be randomized to receive atezolizumab 1200 mg IV every 3 weeks in 12 months or standard of care (observation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
atezolizumab 1200 mg intravenous every 3 weeks in 12 months
Aalborg Universitetshospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
National Cancer Institute
Vilnius, Lithuania
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands
Rijnstate Ziekenhuis
2 year survival
Time frame: 2 year after enrollment is completed
Progression free survival
Time frame: 2 year after enrollment is completed
Best response rate during study treatment period
Time frame: 2 year after enrollment is completed
Number of treatment-related adverse events as assessed by CTCAE v5.0
The number of mild (grade 1-2), severe (grade 3-4) and fatal (grade 5) events during the chemoradiotherapy will be reported for the whole study cohort.
Time frame: 13 months after last patient completed atezolizumab therapy
Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires.
Patients will report HRQoL before and after chemoradiotherapy and then at each evaluation the first 2 years. Mean scores will be compared at each timepoint. A difference of 10 points or more is considered clinically relevant.
Time frame: 2 year after enrollment is completed
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Arnhem, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Medische Centrum Twente
Enschede, Netherlands
Erasmus MC
Rotterdam, Netherlands
Zuyderland Ziekenhuis
Sittard, Netherlands
...and 31 more locations