COMBINATORY IMMUNOTHERAPY-2 (COM-IT-2)
- Conditions
- on small cell lung cancer, stage IVPatients are eligible if when they are planned to start immunotherapy according to standard routines and are not in need of radiotherapyTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-003266-13-NO
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
1.Age >18 years
2.Written informed consent
3.Advanced NSCLC with clinical indication of starting systemic treatment with immunotherapy alone or in combination with chemotherapy (first or later lines)
4.Available core or excisional biopsy of a tumour lesion
5.Measurable disease according to RECIST criteria (RECIST 1.1)
6.Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7.Life expectancy > 3 months
8.At least 1 tumour lesion suitable for radiotherapy treatment
9.Adequate organ function based on clinical examination and lab values
Hb>9 g/dL
Neutrophils >1500 pr mm3
Estimated creatinin clearance >40 mL/min
AST and ALT <2.5 x upper normal limit (if liver metastases: AST/ALT must be <5x upper normal limit)
Serum bilirubin < 1.5 x upper normal limit
10.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
11.Able to understand oral and written information and able to answer questionnaires
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1.Disease suitable for curative salvage surgery
2.Indication for radiotherapy other than stereotactic radiosurgery of brain metastases
3.Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 2 weeks prior to first administration of study drug.
4.Expected use of anti-inflammatory medications as defined in 5.7.1 during the treatment period
5.Significant cardiac, pulmonary or other medical illness that would limit activity or survival
6.Previous treatment with PD1/PDL-1 inhibitor
7.Radiotherapy given within the last 4 weeks prior to inclusion
8.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
9.Pregnancy or lactation
10.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
11.Patients with EGFR-mutation or ALK-translocation not previously treated with tyrosine kinase inhibitor
12.Known hypersensitivity to the immunotherapy regimen planned for the patient the investigational product
13.Patients who test positive for hepatitis B, C or HIV.
14.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
15.Live vaccine administered last 30 days, active infection requiring IV antibiotics, active viral hepatitis or HIV
16.Previous allogenic or organ transplant
17.Diagnosis of immunodeficiency or medical condition requiring high doses (>20 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy
18.Any reason why, in the opinion of the investigator, the patient should not participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the trial is to study the acute and subacute toxicity of adding extensive radiotherapy to immunotherapy in the treatment of non small cell lung cancer with stage IV disease;Secondary Objective: The secondary objectives are to study the effect and quality of life of the treatment in question. <br>Specifically, secondary objectives are to evaluate: <br>- progression free survival and overall survival<br>- response rate, duration of respons<br>- Time to NeXT treatment<br>- Health related quality of life<br>- therapy response in non-irradiated lesions, if any<br>Exploratory objectives: Investigate<br>- biomarkers of treatment response <br>- immune response <br>- imaging to predict therapy response<br>- ctDNA as a tool to monitoring treatment effect;Primary end point(s): Primary: Acute (<3 months) and subacute (3-6 months) toxicity ;Timepoint(s) of evaluation of this end point: 3-6 monts
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PFS<br>OS<br>ORR<br>DoR<br>TNT<br>HR-QoL: EORTC QLQ-C30 and QLQ-LC29;Timepoint(s) of evaluation of this end point: 3, 6 and 12, 18 and 24 months