A randomized phase II study comparing atezolizumab after concurrent chemo-radiotherapy with chemo-radiotherapy alone in limited disease small-cell lung cancer (ACHILES study). - ACHILES

orwegian University of Science and Technology, Department of Clinical and molecular medicine0 sites212 target enrollmentOctober 3, 2019

Conditionsimited disease small-cell lung cancer MedDRA version: 21.1Level: PTClassification code 10041069Term: Small cell lung cancer limited stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: imited disease small-cell lung cancer
Sponsor: orwegian University of Science and Technology, Department of Clinical and molecular medicine
Enrollment: 212
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 3, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

orwegian University of Science and Technology, Department of Clinical and molecular medicine

Eligibility Criteria

Inclusion Criteria

•1\.Histologically or cytologically confirmed small\-cell lung cancer
•2\.No prior systemic therapy for SCLC or immune checkpoint blockade therapy
•3\.Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT of 45 Gy. If it later turns out that 45 Gy cannot be administered, the patient should be excluded.
•4\.Stage I\-III according to TNM v8 ineligible for surgery provided all lesions can be included in a tolerable radiotherapy field (limited disease”)
•5\.Age \= 18 years
•6\.ECOG performance status 0\-2
•7\.Measureable disease according to the RECIST 1\.1
•8\.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

Exclusion Criteria

•11\.Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
•12\.Any autoimmune or lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or equivalent dose of other steroid)
•13\.Any previous allogeneic or organ transplant
•14\.Any 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
•15\.Any 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
•16\.Any live vaccine last 30 days, active infection requiring IV antibiotics, no active viral hepatitis or HIV\-positive
•17\.Any conditions – medical, social, psychological – which could prevent adequate information and follow\-up
•18\.Any 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.
•19\.Pregnancy or lactating women