COMBINATORY IMMUNOTHERAPY-2 (COM-IT-2)A phase 2 randomised open two-arm study to assess the tolerability and efficacy of immunotherapy combined with extensive radiotherapyfor the treatment of stage IV non-small cell lung cancer
- Conditions
- on-small cell lung cancer (Stage IV)Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Registration Number
- CTIS2023-510089-28-00
- Lead Sponsor
- Oslo University Hospital HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
• Stage IV NSCLC with clinical indication of starting systemic treatment with immunotherapy alone or in combination with chemotherapy (first or later lines), 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, Able to understand oral and written information and able to answer questionnaires, • Available core or excisional biopsy of a tumour lesion, • Measurable disease according to RECIST criteria (RECIST 1.1), • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, • Life expectancy > 3 months, • At least 1 tumour lesion suitable for radiotherapy treatment, Age >18 years, Written informed consent, 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)
• Indication for radiotherapy other than stereotactic radiosurgery of brain metastases, 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., Known hypersensitivity to the immunotherapy regimen planned for the patient the investigational product, Live vaccine administered last 30 days, active infection requiring IV antibiotics, active viral hepatitis or HIV, Previous allogenic or organ transplant, Any reason why, in the opinion of the investigator, the patient should not participate, Pregnancy or lactation, Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 2 weeks prior to first administration of study drug., Disease suitable for curative salvage surgery, • Significant cardiac, pulmonary or other medical illness that would limit activity or survival, • Previous treatment with PD1/PDL-1 inhibitor, • Radiotherapy given within the last 4 weeks prior to inclusion, • 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, • Patients with EGFR-mutation or ALK-translocation not previously treated with tyrosine kinase inhibitor, • Patients who test positive for hepatitis B, C or HIV, • 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, • Diagnosis of immunodeficiency or medical condition requiring high doses (>20 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the acute toxicity (<3 months) and subacute toxicity (3-6 months) of immunotherapy combined with extensive radiotherapy in patients with stage IV NSCLC.;Secondary Objective: The secondary objectives are to evaluate measures of treatment effect (PFS, OS, DoR, ORR, TNT) and HRQoL between the treatment arms.;Primary end point(s): 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Adverse events and laboratory values will be graded according to the NCI-CTCAE version 5.0. and published;Secondary end point(s):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.;Secondary end point(s):HRQoL will be evaluated at baseline, end of radiotherapy and at 3 and 6 months for both study arms and published.