Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

Launched by NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY · May 28, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with limited disease small-cell lung cancer (LD SCLC) who have already received chemotherapy and radiation therapy. The researchers want to find out if adding atezolizumab, a type of immunotherapy that helps the body's immune system fight cancer, can help patients live longer compared to those who only receive the typical chemotherapy and radiation treatment.

To participate in this trial, patients should have been diagnosed with small-cell lung cancer that is not suitable for surgery and should be able to tolerate the treatment plan. They should also be physically able to handle the demands of the study, which includes being in relatively good health and having certain organ functions within normal ranges. Participants will receive atezolizumab after their initial treatment and will be monitored for their health and response to the therapy. This trial is currently active, and while it’s not recruiting new participants at the moment, it aims to provide important insights into improving outcomes for patients with this challenging type of cancer.

Gender

ALL

Eligibility criteria

• 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