Carcinoma, Non-Small-Cell LungPhase 1/2NCT03148327
Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy
A Phase 1/2 study testing Durvalumab (MEDI 4736) and Radiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Jonsson Comprehensive Cancer Center at 4 sites in 2 countries.
Trial summary
This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Durvalumab (MEDI 4736) and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 11 Oct 2017to 23 Apr 2026
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion in the study subjects must fulfill all of the following criteria:
- Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation.
- Newly diagnosed, untreated, biopsy proven non-small cell lung cancer.
- Medically inoperable or patient refusal to surgery as defined by any single of the following criteria: a. Determined unfit for surgery by thoracic surgeon or radiation oncologist as documented in the medical record b. Pulmonary function test (PFTS) showing Forced Expiratory Volume in the first second (FEV1) ≤ 1.2 L or diffusing Lung Capacity (DLC) <60%, c. Poor exercise tolerance or failed pre-operative cardiac work-up, d. Patient refusal to undergo definitive surgery as documented in clinical note by a surgeon, pulmonologist, medical oncologist, or radiation oncologist.
- Clinically stage I disease by American Joint Committee on Cancer (AJCC) 7th edition. (N0, M0, T stages T1-T2a) or patients with stage T2bN0M0 (clinical stage IIA) disease who are medically unfit for standard of care chemotherapy as documented by a medical oncologist or radiation oncologist, or who refuse standard of care chemotherapy as documented by a medical oncologist or radiation oncologist.
- Age > 18 years at time of study entry.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Adequate normal organ and marrow function as defined below:
- Haemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3).
- Platelet count ≥ 100 x 109/L (>100,000 per mm3).
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). <<This will not apply to subjects 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.>>
- aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT)/ alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN.
- Serum creatinine creatinine clearance (CL) >40 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) x 0.85 72 x serum creatinine (mg/dL)
- Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
- Subject 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
- ECOG Performance status >1.
- Patients with metastatic or node positive NSCLC.
- Patients with prior radiation therapy to the same bronchopulmonary segment.
- History of automimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), vascular thrombosis associated with antiphospholipid syndrome, Wegner's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis.
- However, patients with type 1 diabetes mellitus, vitiligo, alopecia, hypothyroidism requiring hormone replacement, Graves disease, or skin disorders not requiring systemic treatment are permitted to enroll.
- Patients with history of idiopathic pulmonary fibrosis, idiopathic pneumonitis, drug induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
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- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Participation in another clinical study with an investigational product during the last 6 months.
- Any previous treatment with a Programmed Death-1 (PD1) or Programmed Death-Ligand 1(PD-L1) inhibitor, including durvalumab, and therapeutic anticancer vaccine.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ.
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
- Any unresolved ≥ Grade 2 pulmonary toxicity from previous anti-cancer therapy.
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.
- History of primary immunodeficiency.
- History of allogeneic organ transplant.
- History of hypersensitivity to durvalumab or any excipient.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
- Known history of previous clinical diagnosis of tuberculosis.
- History of leptomeningeal carcinomatosis.
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
- Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
- Subjects with uncontrolled seizures. -
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Colorado
Denver, Colorado, 80217-3364
Jonsson Comprehensieve Cancer Center
Los Angeles, California, 90095
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
About this study
Official title: Randomized Phase I/II Study of Ablative Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early-Stage Non-Small Cell Lung Cancer
This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone.
Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.
Read the detailed description
This is a single center, prospective, randomized phase II study with a phase I safety lead in. Patients in this study will undergo radiation therapy alone or in combination with durvalumab (MEDI 4736). Patients eligible for treatment must be diagnosed with node negative, non-metastatic, biopsy- proven early-stage NSCLC and be ineligible for surgical resection or refuse surgical resection.
Enrollment will begin with a phase I lead in evaluating radiation therapy with durvalumab (MEDI 4736). (Regimen A) to ensure general safety of this combination and specifically relating to pulmonary toxicity (pneumonitis), cardiac toxicity (pericarditis) and gastrointestinal toxicity (esophagitis, gastritis, enterocolitis). Following initial demonstration of safety, enrollment to the phase II component with 1:1 randomization to radiation therapy and durvalumab (MEDI 4736), (Regimen A) or radiation therapy alone (Regimen B) will be performed with stratification only based on T-stage (Tumor) (T1 versus T2). A total of 90 patients will be randomized in the phase II component.
Regimen A:
Durvalumab (MEDI 4736), at 1500 mg via IV infusion will be delivered on day -5 of therapy. Radiation therapy will start on Day 0 ±5 from the first infusion of durvalumab (MEDI 4736) and patients will receive 3, 4, or 10 fractions of radiation therapy to a total dose of 54 Grays (Gy), 50Gy, or 65Gy, respectively.
Starting on day 23 (28 days post first durvalumab (MEDI 4736), infusion), durvalumab (MEDI 4736), 1500mg IV q4weeks will be delivered for up to 4 additional cycles or until progression, toxicity or withdrawal from study.
Regimen B:
Patients will receive radiation therapy alone of 3, 4, or 10 fractions to a total dose of 54Gy, 50Gy, or 65Gy, respectively. Regimen B patients will not receive durvalumab (MEDI 4736) and will only receive radiation therapy.
Safety review will continue to occur on an ongoing basis. Should the rates of grade 3 treatment-related pulmonary toxicity (defined as pneumonitis), cardiac toxicity (defined as pericarditis) or gastrointestinal toxicity (defined as esophagitis, gastritis or enter colitis) be observed at a frequency greater than 15%, accrual will be halted and study will be re-evaluated. Should any patient have ≥ grade 4 treatment-related adverse effects, accrual will be halted and study will be re-evaluated Follow-up Routine surveillance computerized axial tomography (CT) imaging of the chest, abdomen, and pelvis will be performed starting at 12 weeks after completion of radiation in both treatment groups to allow for primary endpoint assessment. Routine CT imaging surveillance will continue per standard of care. Patients will also be followed clinically with history and physical examinations, vitals signs, and laboratory examinations as indicated.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Durvalumab (MEDI 4736), Radiotherapy
- 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.
Durvalumab (MEDI 4736)Drug
Early studies has shown to possibly reduce the growth of certain types of lung cancer
RadiotherapyRadiation
Stereotactic Body Radiation Therapy (SABR)
| Study group | Role | What they receive |
|---|---|---|
| Regimen A: Phase I | Experimental | The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736) Receives: Drug: Durvalumab (MEDI 4736); Radiation: Radiotherapy |
| Regimen A: Phase II | Experimental | The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736) Receives: Drug: Durvalumab (MEDI 4736); Radiation: Radiotherapy |
| Regimen B: Phase II | Active comparator | Radiotherapy alone Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: The number and severity of study participants' treatment-related adverse events as assessed by CTCAE v4.0.
the safety and tolerability associated with radiation therapy and durvalumab (MEDI 4736)
Measured: 4 months
Phase II: Median Progression-Free Survival
Progression Free Survival for patients treated with radiation therapy with and without durvalumab (MEDI 4736) will be determined by both the 2-year progression free survival rate (percentage) and the median progression free survival (in years).
Measured: 2 year
Secondary outcomes (7)
Overall survival
the efficacy of radiation therapy and durvalumab in terms of overall survival
Measured: 2 year
Primary Tumor Control
the efficacy of radiation therapy and durvalumab in terms of primary tumor control
Measured: 2 year
Intralobar recurrence rates
the efficacy of radiation therapy and durvalumab in terms of intralobar recurrence rates
Measured: 2 year
mediastinal recurrences
the efficacy of radiation therapy and durvalumab in terms of mediastinal recurrences
Measured: 2 year
hilar and mediastinal recurrences
the efficacy of radiation therapy and durvalumab in terms of hilar and mediastinal recurrences
Measured: 2 year
rate of distant recurrences
the efficacy of radiation therapy and durvalumab (MEDI 4736) in terms of the rate of distant recurrences
Measured: 2 years
rates of grade 3 or higher non-hematological toxicities
rates of grade 3 or higher non-hematological toxicities with the combination of radiation therapy and durvalumab MEDI 4736)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start11 Oct 2017
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Ann Raldow, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148327
- Sponsor's protocol ID
- 17-000004
- Other IDs
- NCI-2017-00954
- Status last verified
- Jul 2026
- First submitted
- 3 May 2017
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu TC, Stube A, Felix C, Oseguera D, Romero T, Goldman J, Garon EB, Lee JM, Glaspy J, Lisberg AE, Rusthoven CG, Camidge DR, Siva S, Solomon B, Lee A, Tenn SE, Shaverdian N, Steinberg ML, Raldow AC, Lee P. Safety and Efficacy Results From iSABR, a Phase 1 Study of Stereotactic ABlative Radiotherapy in Combination With Durvalumab for Early-Stage Medically Inoperable Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):118-122. doi: 10.1016/j.ijrobp.2023.03.069. Epub 2023 Apr 5. No abstract available.
PubMed 37023987
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase I/II Study of Ablative Radiotherapy +/- MEDI 4736 (Durvalumab) for Medically Inoperable Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03148327
- Acronym / sponsor ID
- 17-000004
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 11 May 2017 (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.
This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone.
Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.
Detailed description
This is a single center, prospective, randomized phase II study with a phase I safety lead in. Patients in this study will undergo radiation therapy alone or in combination with durvalumab (MEDI 4736). Patients eligible for treatment must be diagnosed with node negative, non-metastatic, biopsy- proven early-stage NSCLC and be ineligible for surgical resection or refuse surgical resection.
Enrollment will begin with a phase I lead in evaluating radiation therapy with durvalumab (MEDI 4736). (Regimen A) to ensure general safety of this combination and specifically relating to pulmonary toxicity (pneumonitis), cardiac toxicity (pericarditis) and gastrointestinal toxicity (esophagitis, gastritis, enterocolitis). Following initial demonstration of safety, enrollment to the phase II component with 1:1 randomization to radiation therapy and durvalumab (MEDI 4736), (Regimen A) or radiation therapy alone (Regimen B) will be performed with stratification only based on T-stage (Tumor) (T1 versus T2). A total of 90 patients will be randomized in the phase II component.
Regimen A:
Durvalumab (MEDI 4736), at 1500 mg via IV infusion will be delivered on day -5 of therapy. Radiation therapy will start on Day 0 ±5 from the first infusion of durvalumab (MEDI 4736) and patients will receive 3, 4, or 10 fractions of radiation therapy to a total dose of 54 Grays (Gy), 50Gy, or 65Gy, respectively.
Starting on day 23 (28 days post first durvalumab (MEDI 4736), infusion), durvalumab (MEDI 4736), 1500mg IV q4weeks will be delivered for up to 4 additional cycles or until progression, toxicity or withdrawal from study.
Regimen B:
Patients will receive radiation therapy alone of 3, 4, or 10 fractions to a total dose of 54Gy, 50Gy, or 65Gy, respectively. Regimen B patients will not receive durvalumab (MEDI 4736) and will only receive radiation therapy.
Safety review will continue to occur on an ongoing basis. Should the rates of grade 3 treatment-related pulmonary toxicity (defined as pneumonitis), cardiac toxicity (defined as pericarditis) or gastrointestinal toxicity (defined as esophagitis, gastritis or enter colitis) be observed at a frequency greater than 15%, accrual will be halted and study will be re-evaluated. Should any patient have ≥ grade 4 treatment-related adverse effects, accrual will be halted and study will be re-evaluated Follow-up Routine surveillance computerized axial tomography (CT) imaging of the chest, abdomen, and pelvis will be performed starting at 12 weeks after completion of radiation in both treatment groups to allow for primary endpoint assessment. Routine CT imaging surveillance will continue per standard of care. Patients will also be followed clinically with history and physical examinations, vitals signs, and laboratory examinations as indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regimen A: Phase I | Experimental | Drug: Durvalumab (MEDI 4736), Radiation: RadiotherapyThe intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736) |
| Regimen A: Phase II | Experimental | Drug: Durvalumab (MEDI 4736), Radiation: RadiotherapyThe intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736) |
| Regimen B: Phase II | Active comparator | Radiation: RadiotherapyRadiotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluation.
- Newly diagnosed, untreated, biopsy proven non-small cell lung cancer.
- Medically inoperable or patient refusal to surgery as defined by any single of the following criteria: a. Determined unfit for surgery by thoracic surgeon or radiation oncologist as documented in the medical record b. Pulmonary function test (PFTS) showing Forced Expiratory Volume in the first second (FEV1) ≤ 1.2 L or diffusing Lung Capacity (DLC) <60%, c. Poor exercise tolerance or failed pre-operative cardiac work-up, d. Patient refusal to undergo definitive surgery as documented in clinical note by a surgeon, pulmonologist, medical oncologist, or radiation oncologist.
- Clinically stage I disease by American Joint Committee on Cancer (AJCC) 7th edition. (N0, M0, T stages T1-T2a) or patients with stage T2bN0M0 (clinical stage IIA) disease who are medically unfit for standard of care chemotherapy as documented by a medical oncologist or radiation oncologist, or who refuse standard of care chemotherapy as documented by a medical oncologist or radiation oncologist.
- Age > 18 years at time of study entry.
Key exclusion criteria (27 listed)
- ECOG Performance status >1.
- Patients with metastatic or node positive NSCLC.
- Patients with prior radiation therapy to the same bronchopulmonary segment.
- History of automimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), vascular thrombosis associated with antiphospholipid syndrome, Wegner's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis.
- Patients with history of idiopathic pulmonary fibrosis, idiopathic pneumonitis, drug induced pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
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 |
|---|---|---|
| Durvalumab (MEDI 4736)Early studies has shown to possibly reduce the growth of certain types of lung cancer | Drug | Regimen A: Phase I, Regimen A: Phase II |
| RadiotherapyStereotactic Body Radiation Therapy (SABR) | Radiation | Regimen A: Phase I, Regimen A: Phase II, Regimen B: Phase II |
Primary outcome
Phase I: The number and severity of study participants' treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 4 months
the safety and tolerability associated with radiation therapy and durvalumab (MEDI 4736)
Phase II: Median Progression-Free Survival
Time frame: 2 year
Progression Free Survival for patients treated with radiation therapy with and without durvalumab (MEDI 4736) will be determined by both the 2-year progression free survival rate (percentage) and the median progression free survival (in years).
7 secondary outcomes
Overall survival
Time frame: 2 year
Primary Tumor Control
Time frame: 2 year
Intralobar recurrence rates
Time frame: 2 year
mediastinal recurrences
Time frame: 2 year
hilar and mediastinal recurrences
Time frame: 2 year
rate of distant recurrences
Time frame: 2 years
rates of grade 3 or higher non-hematological toxicities
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 37023987Wu TC, Stube A, Felix C, Oseguera D, Romero T, Goldman J, Garon EB, Lee JM, Glaspy J, Lisberg AE, Rusthoven CG, Camidge DR, Siva S, Solomon B, Lee A, Tenn SE, Shaverdian N, Steinberg ML, Raldow AC, Lee P. Safety and Efficacy Results From iSABR, a Phase 1 Study of Stereotactic ABlative Radiotherapy in Combination With Durvalumab for Early-Stage Medically Inoperable Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):118-122. doi: 10.1016/j.ijrobp.2023.03.069. Epub 2023 Apr 5. No abstract available.
- Individual participant dataSharing planned: No
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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.
Ann Raldow, MD principal investigator
Associate Professor
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Durvalumab (MEDI 4736) and Radiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Jonsson Comprehensive Cancer Center at 4 sites in 2 countries.
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 23 inclusion and 27 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Low accrual). 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?
Phase I: The number and severity of study participants' treatment-related adverse events as assessed by CTCAE v4.0. (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148327, which also lists 1 linked publication.
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 16 Jul 2026.