NCT03540420Active, not recruitingPhase 2
A Randomized Phase II Study Comparing Atezolizumab After Concurrent Chemo-radiotherapy With Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer
Norwegian University of Science and Technology43 sites in 6 countries212 target enrollmentStarted: July 31, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 212
- Locations
- 43
- Primary Endpoint
- 2 year survival
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed small-cell lung cancer
- •Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT of 45 Gy.
- •Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be included in a tolerable radiotherapy field ("limited disease")
- •ECOG performance status 0-2
- •Measureable disease according to the RECIST 1.1
- •Adequate organ function defined as: (a) Serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN); (b) Total serum bilirubin ≤ 1.5 x ULN; (c)Absolute neutrophil count (ANC) ≥ 1.5 x 10 superscr 9/L; (d) Platelets ≥ 100 x 10 superscr 9/L ; (e) Creatinine < 100 µmol/L and calculated creatinine-clearance > 50 ml/min. If calculated creatinine-clearance is < 50 ml/min, an EDTA clearance should be performed
- •No malignant cells in pericardial or pleural fluid (at least 1 sample should be obtained if pleural fluid is present) If there is so little fluid that it cannot easily be collected, the patient is considered eligible.
- •Pulmonary function: FEV1 > 1 l or > 30 % of predicted value and DLCO > 30 % of predicted value
- •Female patients of childbearing potential (Postmenarcheal, not postmenopausal (>12 continuous months of amenorrhea with no identified cause other than menopause), and no surgical sterilization) should use highly effective contraception and take active measures to avoid pregnancy while undergoing atezolizumab treatment and for at least 5 months after the last dose. Birth control methods considered to be highly effective are listed in Appendix D of the protocol
- •Written informed consent
Exclusion Criteria
- •previous systemic therapy for SCLC or immune checkpoint blockade therapy
- •serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the study, or would interfere with the evaluation of the efficacy and safety of the study treatment
- •lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)
- •previous allogeneic or organ transplant
- •active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- •history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •live vaccine administered in the last 30 days
- •active infection requiring IV antibiotics
- •active viral hepatitis or HIV-positive
- •conditions - medical, social, psychological - which could prevent adequate information and follow-up
- •clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (e.g. 5-years OS rate of >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or breast cancer is allowed.
- •pregnant or lactating women
Arms & Interventions
Atezolizumab
Experimental
atezolizumab after completed chemo-radiotherapy and non-progression
Intervention: Atezolizumab (Drug)
Observation
No Intervention
standard care after completed chemo-radiotherapy and non-progression
Outcomes
Primary Outcomes
2 year survival
Time Frame: 2 year after enrollment is completed
Secondary Outcomes
- Best response rate during study treatment period(2 year after enrollment is completed)
- Number of treatment-related adverse events as assessed by CTCAE v5.0(13 months after last patient completed atezolizumab therapy)
- Progression free survival(2 year after enrollment is completed)
- Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires.(2 year after enrollment is completed)
Investigators
Study Sites (43)
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