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New treatment option for Non Small Cell Lung Cancer
Official title Immunotherapy and Carbon Ion Radiotherapy In Solid Cancers With Stable Disease
ClinicalTrials.gov ID: NCT05229614
What this study is testing
What is Immunotherapy (Pembrolizumab)?
Immunotherapy (Pembrolizumab) is an investigational medicine, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Pembrolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent
- Histologic confirmation of malignancies under treatment with single agent anti-PD1/PDL1 immunotherapy per clinical practice (see cohort specific )...
- Having a disease stability as assessed by AIFA monitoring sheet
- Presence of at least 2 measurable target lesions, of which at least one to be followed up as per RECIST and one suitable for CIRT
- Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
You likely can't join if
- Patients treated with chemo-immunotherapy associations
- Patients treated with immunotherapy combinations (e.g. people treated with anti-CTLA4 + anti-PD1/PDL1 are excluded)
- Patients receiving immunotherapy within clinical trials
- Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use
- Patients with high tumor burden defined as \> 10 lesions and/or sum of diameters \> 19 cm
- Patients with distant metastases only located in the CNS are excluded
See the full eligibility criteria
- Signed written informed consent
- Histologic confirmation of malignancies under treatment with single agent anti-PD1/PDL1 immunotherapy per clinical practice (see cohort specific ) with immune checkpoint inhibitors approved by Italian national drug...
- Having a disease stability as assessed by AIFA monitoring sheet
- Presence of at least 2 measurable target lesions, of which at least one to be followed up as per RECIST and one suitable for CIRT
- Willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Females and males, 18 years of age or older (no upper limit for age)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- people must have measurable disease by CT or MRI per RECIST 1.1
- Patients treated with chemo-immunotherapy associations
- Patients treated with immunotherapy combinations (e.g. people treated with anti-CTLA4 + anti-PD1/PDL1 are excluded)
- Patients receiving immunotherapy within clinical trials
- Patients receiving off-label immunotherapy or within expanded access programs or as compassionate use
- Patients with high tumor burden defined as \> 10 lesions and/or sum of diameters \> 19 cm
- Patients with distant metastases only located in the CNS are excluded
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive...
- Patients with autoimmune diseases (ADs), including local and systemic collagen-vascular (CVD) and inflammatory bowel diseases (IBD)
- Previous RT, regardless of energy, on the metastatic site selected to be irradiated.
- Any immune-related CTCAE grade 4 adverse event, before study entry
- Any CTCAE grade ≥3 immune-related adverse event observed within 3 weeks prior to CIRT start
- Presence of metal prostheses or any other condition to prevent adequate imaging for identification of the target volume and calculation of the dose
- Loco-regional conditions not allowing hadron therapy (e.g. active infections in RT target region)
- Prisoners or people who are involuntarily incarcerated
- people who are compulsorily detained for treatment of either a psychiatric or physical illness (e.g. infectious disease)
The study team makes the final eligibility decision.
Where it's taking place
- Darmstadt, Germany
- Milan, Italy
- Pavia, Italy
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darmstadt, Germany; Milan, Italy; Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.