BridgeMD
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
EU CTIS ID: 2023-510089-28-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • 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
See the full eligibility criteria
Who can join
- • 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)
What rules you out
- • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.