Non-Small Cell Lung CancerEarly Phase 1NCT03818776
Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable NSCLC
A Early Phase 1 study testing Durvalumab and Proton beam therapy RT in people with Non-Small Cell Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Durvalumab and Proton beam therapy RT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2019to 27 Jan 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-2
- Body Weight >30kg
- Must have anticipated life expectancy of at least 12 weeks
- Must be histologically or cytologically confirmed to be non-small cell lung cancer (NSCLC) confirmed by biopsy within 90 days of registration.
- Any tumor PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment)
- AJCC 8th Stage IIA-IIIC.
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- Must be deemed by Specialist or tumor board decision to not be a candidate for surgical resection or the participant refuses resection. Being deemed unresectable can be for any reason, including but not limited to: tumor location, tumor characteristics, operative risks, poor participant lung function, participant age or medical comorbidity.
- Must be deemed by Medical Oncologist or tumor board decision to not be a candidate for or able to tolerate standard cisplatinum based doublet concurrent chemoradiation therapy or the participant refuses chemotherapy. Being deemed not a chemotherapy candidate can be for any reason, including but not limited to: age, medical comorbidity, end organ dysfunction.
- Pulmonary function testing performed within 365 days prior to registration. . Sufficient lung function as judged by the primary investigator based on anticipated radiation fields, with a minimum of FEV1 ≥ 0.7 Liter or ≥ 30% and DLCO ≥ 30% with or without bronchodilator within 365 days prior to registration.
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) 1.5 (or 1.0) x (> 1500 per mm3)
- Platelet count ≥75 x 109/L (>75,000 per mm3)
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to participants with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal
- Measured creatinine clearance (CL) >30 mL/min or Calculated creatinine CL>30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL))
- Females:
- Creatinine CL (mL/min) = (Weight (kg) x (140 - Age)) / (72 x serum creatinine (mg/dL)) x 0.85
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Prior large field thoracic radiation therapy is not allowed except for at the discretion of the primary investigator. Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed. Other prior thoracic radiation is allowed at the discretion of the primary investigator.
- Prior radiation therapy, or immunotherapy for current diagnosis of NSCLC
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence
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- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ (i.e. breast) without evidence of disease
- Low risk prostate cancer which has been treated or is undergoing active surveillance.
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
- Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- Judgment by the investigator that the participant is unsuitable to participate in the study and the participant is unlikely to comply with study procedures, restrictions and requirements
- Medication Specific Exclusion Criterion:
- History of primary immunodeficiency
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Participants with vitiligo or alopecia
- Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Participants without active disease in the last 5 years may be included but only after consultation with the study physician
- Participants with celiac disease controlled by diet alone
- Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation
- Treatment with systemic immunosuppressive medications (including but not limited to prednisone > 10 mg daily, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1. However, the use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies). Participants with a past or resolved hepatitis B (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Participants, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
- Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: A Pilot Trial of Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable Non-Small Cell Lung Cancer With Extended Durvalumab Therapy (PARTICLE-D)
The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous in treating lung cancer because it allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.
Read the detailed description
All study participants will receive the same study intervention, which will consist of proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will be delivered using cardiac sparing accelerated fractionated proton radiation. Radiation will have two dose escalation schemes followed by an expansion cohort for a total of approximately 24 participants enrolled at University Hospitals Cleveland Medical Center.
The objectives of this study are to evaluate the safety and feasibility of combination of durvalumab with two different schemes for accelerated fractionation proton radiation in participants who are unable to tolerate concurrent chemoradiation therapy. This will also include the evaluation of adverse events resulting from these treatment schemes.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Durvalumab, Proton beam therapy RT
- Keywords
- Durvalumab, PARTICLE-D
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody immunotherapy for lung cancer. Participants will receive 1500mg durvalumab via intravenous (IV) infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. (N.b. If a participant's weight falls to 30kg (≤30 kg)), then the participant should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W after consultation between Investigator and Study Physician, until the weight improves to above 30 kg >30 kg, at which point the participant should start receiving the fixed dosing of durvalumab 1500 mg Q4W).
Proton beam therapy RTRadiation
Proton beam therapy is a type of RT where the proton stops at a specific depth according to its energy which allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - 60 CGyE in 20 fractions | Experimental | Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT.
Radiation will follow dose escalation scheme:
60 CGyE in 20 fractions (3+3 participants, 3-6 total) Receives: Drug: Durvalumab; Radiation: Proton beam therapy RT |
| Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a | Experimental | Proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT.
Radiation will follow dose escalation scheme:
69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants) Receives: Drug: Durvalumab; Radiation: Proton beam therapy RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of intervention as defined by number of participants with Dose Limiting Toxicities (DLT) between first dose of Durvalumab and 30 days following completion of radiotherapy.
Safety of intervention as defined by number of participants with DLT's between first dose of Durvalumab and 30 days following completion of radiotherapy. This is defined as 0 of 3 or 1 of 6 participants having no DLT of either Durvalumab or RT.
DLT for RT defined as:
- Grade 4-5 non-hematologic serious adverse events (SAEs) considered by the Investigators to be probably or definitely related to protocol treatment.
- Grade 3 or higher cardiac adverse events (e.g. severely symptomatic congestive heart failure (CHF), myocarditis, pericardial effusion, myocardial infarction, symptomatic arrhythmia) considered by the Investigators to be probably or definitely related to protocol treatment.
- Grade 3 or higher pulmonary adverse events (e.g. dyspnea/pneumonitis) considered by the Investigators to be probably or definitely related to protocol treatment and not responsive to steroids.
- Failure to receive at least 54
Measured: Up to 30 days following end of treatment
Secondary outcomes (2)
Feasibility of intervention defined by number of participants receiving full course of RT treatment and minimum of two doses of Durvalumab
Feasibility of intervention is defined as a participant receiving the entire course of prescribed RT as well as having received a minimum of two doses of Durvalumab.
Measured: Up to 30 days following end of treatment
Number of participants with Adverse Events according to CTCAE v5.0
All toxicities will be graded according to NCI CTCAE, Version 5.0. See Adverse Events section.
Measured: Up to 30 days following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start30 Aug 2019
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Why it stopped: Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arm 1: 60 CGyE in 20 fractions (3+3 participants, 3-6 total) Arm 2: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants)
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debora Bruno, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818776
- Sponsor's protocol ID
- CASE1518
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Proton Based Cardiac Sparing Accelerated Fractionated RadioTherapy in Unresectable Non-Small Cell Lung Cancer With Extended Durvalumab Therapy (PARTICLE-D)
- ClinicalTrials.gov ID
- NCT03818776
- Acronym / sponsor ID
- CASE1518
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Durvalumab, PARTICLE-D
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to treat participants with the combination of durvalumab (the study drug) and proton beam therapy. Proton beam therapy is a type of radiotherapy (RT) with a unique characteristic where the proton stops at a specific depth according to its energy. This may be advantageous in treating lung cancer because it allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.
Detailed description
All study participants will receive the same study intervention, which will consist of proton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will be delivered using cardiac sparing accelerated fractionated proton radiation. Radiation will have two dose escalation schemes followed by an expansion cohort for a total of approximately 24 participants enrolled at University Hospitals Cleveland Medical Center.
The objectives of this study are to evaluate the safety and feasibility of combination of durvalumab with two different schemes for accelerated fractionation proton radiation in participants who are unable to tolerate concurrent chemoradiation therapy. This will also include the evaluation of adverse events resulting from these treatment schemes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: 60 CGyE in 20 fractions (3+3 participants, 3-6 total) Arm 2: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - 60 CGyE in 20 fractions | Experimental | Drug: Durvalumab, Radiation: Proton beam therapy RTProton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 60 CGyE in 20 fractions (3+3 participants, 3-6 total) |
| Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a | Experimental | Drug: Durvalumab, Radiation: Proton beam therapy RTProton based external beam radiation therapy with concurrent Durvalumab starting one week before RT. Radiation will follow dose escalation scheme: 69 CGyE in 23 fractions (3+3 participants, 3-6 total) Followed by expansion cohort at identified RP2 dose (12 participants) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- ECOG performance status 0-2
- Body Weight >30kg
- Must have anticipated life expectancy of at least 12 weeks
- Must be histologically or cytologically confirmed to be non-small cell lung cancer (NSCLC) confirmed by biopsy within 90 days of registration.
- Any tumor PD-L1 expression is allowed (including 0% to 100%, or unknown at time of study enrollment)
Key exclusion criteria (29 listed)
- Prior large field thoracic radiation therapy is not allowed except for at the discretion of the primary investigator. Prior SBRT to contralateral lung, or breast radiation greater than 3 years prior is allowed. Other prior thoracic radiation is allowed at the discretion of the primary investigator.
- Prior radiation therapy, or immunotherapy for current diagnosis of NSCLC
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Female participants who are pregnant or breastfeeding or male or female participants of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- History of another primary malignancy except for:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody immunotherapy for lung cancer. Participants will receive 1500mg durvalumab via intravenous (IV) infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. (N.b. If a participant's weight falls to 30kg (≤30 kg)), then the participant should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W after consultation between Investigator and Study Physician, until the weight improves to above 30 kg >30 kg, at which point the participant should start receiving the fixed dosing of durvalumab 1500 mg Q4W). | Drug | Arm 1 - 60 CGyE in 20 fractions, Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a |
| Proton beam therapy RTProton beam therapy is a type of RT where the proton stops at a specific depth according to its energy which allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord. | Radiation | Arm 1 - 60 CGyE in 20 fractions, Arm 2 - 69 CGyE in 23 fractions followed by expansion cohort a |
Primary outcome
Safety of intervention as defined by number of participants with Dose Limiting Toxicities (DLT) between first dose of Durvalumab and 30 days following completion of radiotherapy.
Time frame: Up to 30 days following end of treatment
Safety of intervention as defined by number of participants with DLT's between first dose of Durvalumab and 30 days following completion of radiotherapy. This is defined as 0 of 3 or 1 of 6 participants having no DLT of either Durvalumab or RT. DLT for RT defined as: 1. Grade 4-5 non-hematologic serious adverse events (SAEs) considered by the Investigators to be probably or definitely related to protocol treatment. 2. Grade 3 or higher cardiac adverse events (e.g. severely symptomatic congestive heart failure (CHF), myocarditis, pericardial effusion, myocardial infarction, symptomatic arrhythmia) considered by the Investigators to be probably or definitely related to protocol treatment. 3. Grade 3 or higher pulmonary adverse events (e.g. dyspnea/pneumonitis) considered by the Investigators to be probably or definitely related to protocol treatment and not responsive to steroids. 4. Failure to receive at least 54
2 secondary outcomes
Feasibility of intervention defined by number of participants receiving full course of RT treatment and minimum of two doses of Durvalumab
Time frame: Up to 30 days following end of treatment
Number of participants with Adverse Events according to CTCAE v5.0
Time frame: Up to 30 days following end of treatment
Results and safety
The study was stopped early (reason given: Safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debora Bruno, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Durvalumab and Proton beam therapy RT in people with Non-Small Cell Lung Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of intervention as defined by number of participants with Dose Limiting Toxicities (DLT) between first dose of Durvalumab and 30 days following completion of radiotherapy. (time frame: Up to 30 days following end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.