ACHILES Verbessert die Immuntherapie das Überleben von Patienten mit kleinzelligem Lungenkarzinom im Stadium Limited Disease, die eine Chemo- und Strahlentherapie erhalten haben?

Drug: Atezolizumab

Gender: All
Maximum age: N/A
Minimum age: 18 Years

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 ?mol/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, Sj?gren syndrome, Guillain-Barr? 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