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Clinical Trials in the Netherlands / NCT03540420
Active, not recruiting Phase 2

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

NCT03540420 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2018-07-31
Last updated
2026-04-13

Condition(s) studied

Small-cell Lung Cancer

Investigational drug(s) / intervention(s)

Atezolizumab →

Atezolizumab: atezolizumab 1200 mg intravenous every 3 weeks in 12 months

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
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 Arnhem Netherlands
Amphia Ziekenhuis Breda Netherlands
Medische Centrum Twente Enschede Netherlands
Erasmus MC Rotterdam Netherlands
Zuyderland Ziekenhuis Sittard Netherlands
Antonius Ziekenhuis Utrecht Netherlands
Isala Ziekenhuis Zwolle Netherlands
Ålesund Hospital Ålesund Norway
Haukeland Universitetssykehus Bergen Norway
Drammen sykehus - Vestre Viken Drammen Norway
Haugesund hospital Haugesund Norway
Sørlandet Sykehus Kristiansand Norway
Sykehuset i Kristansund Kristiansund Norway
Sykehuset Levanger Levanger Norway
Molde Sjukehus Molde Norway
Akershus Universitetssykehus AHUS Oslo Norway
Oslo University Hospital Ullevål Oslo Norway
Stavanger University Hospital Stavanger Norway
Universitetssykehuset Nord-Norge Tromsø Norway
Cancer Clinic at St. Olavs Hospital Trondheim Norway
Volda hospital Volda Norway
Gävle hospital Gävle Sweden
Sahlgrenska Universitetssjukhus Gothenburg Sweden
Universitetssjukhuset Linköping Linköping Sweden
Skånes University Hospital Lund Sweden
Universitetssjukhuset Örebro Örebro Sweden
Karolinska University Hospital Stockholm Sweden
Universitätsspital Basel Basel Switzerland
Inselspital Bern Switzerland
University Hospital Inselspital Bern Switzerland
Kantonsspital Graubünden Chur Switzerland
Kantonsspital Olten - Solothurner Spitäler Olten Switzerland
Cantonal Hospital of St. Gallen Sankt Gallen Switzerland
Spital STS AG Thun Switzerland
Kantonsspital Winterthur Winterthur Switzerland

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Tecentriq (atezolizumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03540420 on ClinicalTrials.gov ↗ ← All trials in the Netherlands