ATEZOLIZUMAB for Non-small cell lung cancer (Stage IV)

Inclusion criteria

• {"criterion_text":"- • Stage IV NSCLC with clinical indication of starting systemic treatment with immunotherapy alone or in combination with chemotherapy (first or later lines)"}
• {"criterion_text":"- Women of childbearing potential (WOCBP) should use a highly effective method during the treatment period and for at least 5 months after the last dose of immunotherapy to avoid pregnancy. Methods considered as highly effective birth control methods include combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, intravaginal, injectable, implantable or transdermal), intrauterine device (including hormone-releasing), male condom, bilateral tubal occlusion, vasectomised partner or sexual abstinence"}
• {"criterion_text":"- Able to understand oral and written information and able to answer questionnaires"}
• {"criterion_text":"- • Available core or excisional biopsy of a tumour lesion"}
• {"criterion_text":"- • Measurable disease according to RECIST criteria (RECIST 1.1)"}
• {"criterion_text":"- • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2"}
• {"criterion_text":"- • Life expectancy > 3 months"}
• {"criterion_text":"- • At least 1 tumour lesion suitable for radiotherapy treatment"}
• {"criterion_text":"- Age >18 years"}
• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Adequate organ function based on clinical examination and lab values (o Hb>9 g/dL o Neutrophils >1500 pr mm3 o Estimated creatinine clearance >40 mL/min o AST and ALT <2.5 x upper normal limit (if liver metastases: AST/ALT must be <5x upper normal limit) o Serum bilirubin < 1.5 x upper normal limit)"}

Exclusion criteria

• {"criterion_text":"- • Indication for radiotherapy other than stereotactic radiosurgery of brain metastases"}
• {"criterion_text":"- • Significant cardiac, pulmonary or other medical illness that would limit activity or survival"}
• {"criterion_text":"- • Previous treatment with PD1/PDL-1 inhibitor"}
• {"criterion_text":"- • Radiotherapy given within the last 4 weeks prior to inclusion"}
• {"criterion_text":"- • 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"}
• {"criterion_text":"- • Patients with EGFR-mutation or ALK-translocation not previously treated with tyrosine kinase inhibitor"}
• {"criterion_text":"- • Patients who test positive for hepatitis B, C or HIV"}
• {"criterion_text":"- • Known larger active brain metastases that cannot be treated with stereotactic radiotherapy. Patients with stable/previously treated brain metastases can be included. Patients with several smaller brain metastases may be included if the larger metastases are treated with stereotactic radiotherapy"}
• {"criterion_text":"- • Diagnosis of immunodeficiency or medical condition requiring high doses (>20 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy"}
• {"criterion_text":"- Women who are not postmenopausal (postmenopausal defined as ≥ 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study drug. Positive test is exclusion criterion."}
• {"criterion_text":"- Known hypersensitivity to the immunotherapy regimen planned for the patient the investigational product"}
• {"criterion_text":"- Live vaccine administered last 30 days, active infection requiring IV antibiotics, active viral hepatitis or HIV"}
• {"criterion_text":"- Previous allogenic or organ transplant"}
• {"criterion_text":"- Any reason why, in the opinion of the investigator, the patient should not participate"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 2 weeks prior to first administration of study drug."}
• {"criterion_text":"- Disease suitable for curative salvage surgery"}

Primary endpoints

• {"endpoint_text":"- The primary objective is to evaluate the acute toxicity (<3 months) and subacute toxicity (3-6 months) toxicity) of immunotherapy combined with extensive radiotherapy in patients with stage IV NSCLC compared with immunotherapy without radiotherapy.","definition_or_measurement_approach":"Evaluation of acute (<3 months) and subacute (3-6 months) toxicity in the two arms. No specific grading approach is stated in the primary endpoint text (see secondary endpoints for adverse event grading)."}

Secondary endpoints

• {"endpoint_text":"- Adverse events and laboratory values will be graded according to the NCI-CTCAE version 5.0. and published","definition_or_measurement_approach":"Adverse events and laboratory values graded using NCI-CTCAE v5.0."}
• {"endpoint_text":"- Response will be evaluated by iRECIST 1.1 and RECIST 1.1. Survival data (PFS and OS) and response rates (RR and DOR) will be evaluated and published.","definition_or_measurement_approach":"Tumour response evaluated by iRECIST 1.1 and RECIST 1.1; survival endpoints include PFS and OS; response metrics include RR and DOR."}
• {"endpoint_text":"- HRQoL will be evaluated at baseline, end of radiotherapy and at 3 and 6 months for both study arms and published.","definition_or_measurement_approach":"Health-related quality of life measured at baseline, end of radiotherapy, 3 months and 6 months for both arms (measurement instrument not specified in endpoint text)."}

Norway

Earliest CTIS Part Ii Submission Date

16-05-2024

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

400

Number Of Sites

3

Number Of Participants

55

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway