Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIA Non-small Cell Lung Cancer

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02904954
Collaborator
AstraZeneca (Industry)
60
1
2
69.5
0.9

Study Details

Study Description

Brief Summary

The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736) with or without stereotactic body radiation therapy (SBRT) as treatment for stage I (tumors > 2cm), II, and IIIA non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a randomized open label phase II trial of preoperative anti-PD-L1 antibody durvalumab with or without concurrent non-ablative radiation followed by surgical resection and postoperative monthly maintenance durvalumab for twelve months, following standard of care postoperative therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Trial of Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II, and IIIA Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date :
Dec 2, 2016
Actual Primary Completion Date :
Sep 16, 2020
Anticipated Study Completion Date :
Sep 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1 (Durvalumab monotherapy)

Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.

Drug: Durvalumab
Intravenously
Other Names:
  • MEDI4736
  • Experimental: Arm 2 (Durvalumab plus SBRT)

    Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively.

    Drug: Durvalumab
    Intravenously
    Other Names:
  • MEDI4736
  • Other: Durvalumab plus SBRT
    Intravenously
    Other Names:
  • MEDI4736
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Major Pathological Response (MPR) [Durvalumab start date to surgical resection, up to 10 weeks]

      MPR is defined as ≤10% residual viable tumor in the resected specimen.

    Secondary Outcome Measures

    1. Disease-free Survival [From date of Durvalumab start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years.]

      Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.

    2. Objective Clinical Response Rate [Treatment day 1 up to weeks 6-7]

      Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by PET/CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of diameters of target lesions; Progressive Disease (PD), >=20% increase in the sum of diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

    Other Outcome Measures

    1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v. 4.0 [Up to 72 weeks]

      Adverse events ≥G3 in both arms with and without possible or probable attribution to study drug and graded according to CTCAE v. 4.0

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    1. Patient has histologically or cytologically proven clinical stages I (tumors > 2 cm), II, and IIIA NSCLC and is considered eligible for surgical resection with curative intent. Patients with 2 primary non-small cell lung cancers are allowed.

    2. Measureable disease, as defined by RECIST v1.1.

    3. Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures.

    4. Age > 18 years at time of study entry

    5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    6. 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.

    • AST (SGOT)/ALT (SGPT), and alkaline phosphatase ≤ 2.5 x institutional upper limit of normal (ULN).

    • Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault

    1. or by 24-hour urine collection for determination of creatinine clearance:
    1. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. 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 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).

    1. 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.

    2. No prior therapy for their lung cancer.

    Exclusion Criteria

    Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

    1. Participation in another clinical study with an investigational product during the last 3 weeks.

    2. History of another primary malignancy except for:

    • Malignancy treated with curative intent and with no known active disease ≥3 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 eg, cervical cancer in situ, in-situ urinary bladder cancer , treated localized prostate cancer and ductal carcinoma-in situ.

    • Indolent hematological malignancies

    1. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal,inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid, and steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).

    2. Any unresolved toxicity (CTCAE grade 2) from therapy for a prior malignancy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

    • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

    • Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).

    1. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1.

    2. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). No active diverticulitis within the previous 3 months. The following are exceptions to this criterion:

    • Patients with vitiligo or alopecia

    • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement

    • Any chronic skin condition that does not require systemic therapy

    • Patients without active disease in the last 5 years may be included but only after consultation with the study physician

    • Patients with celiac disease controlled by diet alone

    1. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).

    2. History of active primary immunodeficiency.

    3. History of allogeneic organ transplant.

    4. History of hypersensitivity to durvalumab or any excipient.

    5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, 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 patient to give written informed consent.

    6. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.

    7. History of leptomeningeal carcinomatosis.

    8. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.

    9. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.

    10. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

    11. Subjects with uncontrolled seizures.

    12. History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis (including drug induced), or evidence of active pneumonitis on screening chest CT scan.

    13. Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.

    14. Receipt of the last dose of therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigational agent) for an accepted other malignancy as defined in Section 3.3.2 within 30 first dose of study drug for lung cancer.

    15. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medicine New York New York United States 10065

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • AstraZeneca

    Investigators

    • Principal Investigator: Nasser K Altorki, MD, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT02904954
    Other Study ID Numbers:
    • 1501015795
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Weill Medical College of Cornell University
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Of 64 enrolled participants, 60 met inclusion criteria and were randomized to treatment.
    Arm/Group Title Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Arm/Group Description Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab plus SBRT: Intravenously
    Period Title: Neoadjuvant (Preoperative) to Surgery
    STARTED 30 30
    COMPLETED 26 26
    NOT COMPLETED 4 4
    Period Title: Neoadjuvant (Preoperative) to Surgery
    STARTED 26 26
    COMPLETED 6 11
    NOT COMPLETED 20 15

    Baseline Characteristics

    Arm/Group Title Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT) Total
    Arm/Group Description Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab plus SBRT: Intravenously Total of all reporting groups
    Overall Participants 30 30 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    70.5
    (7.5)
    69.6
    (9.4)
    70.2
    (8.5)
    Sex: Female, Male (Count of Participants)
    Female
    14
    46.7%
    15
    50%
    29
    48.3%
    Male
    16
    53.3%
    15
    50%
    31
    51.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    6
    20%
    6
    10%
    Not Hispanic or Latino
    30
    100%
    24
    80%
    54
    90%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    6.7%
    3
    10%
    5
    8.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    10%
    4
    13.3%
    7
    11.7%
    White
    25
    83.3%
    23
    76.7%
    48
    80%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    30
    100%
    30
    100%
    60
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects With Major Pathological Response (MPR)
    Description MPR is defined as ≤10% residual viable tumor in the resected specimen.
    Time Frame Durvalumab start date to surgical resection, up to 10 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Arm/Group Description Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab plus SBRT: Intravenously
    Measure Participants 30 30
    Count of Participants [Participants]
    2
    6.7%
    16
    53.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1 (Durvalumab Monotherapy), Arm 2 (Durvalumab Plus SBRT)
    Comments Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Testing at alpha = 0.05.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 46.6
    Confidence Interval (2-Sided) 95%
    26.7 to 66.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Disease-free Survival
    Description Disease recurrence or death from any cause assessed using history, physical examination and CT scanning, histologically or cytologically confirmed whenever possible.
    Time Frame From date of Durvalumab start date until the date of first documented progression or date of death from any cause, whichever came first, assessed every 6 months for 2 years.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    3. Secondary Outcome
    Title Objective Clinical Response Rate
    Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by PET/CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of diameters of target lesions; Progressive Disease (PD), >=20% increase in the sum of diameters of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
    Time Frame Treatment day 1 up to weeks 6-7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Arm/Group Description Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab (MEDI4736) 1.12 g administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy 1.5 g will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab plus SBRT: Intravenously
    Measure Participants 30 30
    Complete Response
    0
    0%
    0
    0%
    Partial Response
    1
    3.3%
    14
    46.7%
    Progressive Disease
    3
    10%
    1
    3.3%
    Pseudoprogression
    2
    6.7%
    0
    0%
    Stable Disease
    24
    80%
    15
    50%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1 (Durvalumab Monotherapy), Arm 2 (Durvalumab Plus SBRT)
    Comments Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0001
    Comments Testing at alpha = 0.05.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Risk Difference (RD)
    Estimated Value 43.4
    Confidence Interval (2-Sided) 95%
    24.4 to 62.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Other Pre-specified Outcome
    Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v. 4.0
    Description Adverse events ≥G3 in both arms with and without possible or probable attribution to study drug and graded according to CTCAE v. 4.0
    Time Frame Up to 72 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame From enrollment to 90 days after the last dose of durvalumab
    Adverse Event Reporting Description
    Arm/Group Title Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Arm/Group Description Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab (MEDI4736) via IV infusion administered pre-operatively every 3 weeks for 2 cycles plus radiotherapy delivered in 3 daily fractions starting concurrently with the first cycle of durvalumab (MEDI4736) followed by surgical resection. Durvalumab monotherapy will be given for 12 months post-operatively. Durvalumab: Intravenously Durvalumab plus SBRT: Intravenously
    All Cause Mortality
    Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/30 (23.3%) 9/30 (30%)
    Serious Adverse Events
    Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 12/30 (40%) 15/30 (50%)
    Blood and lymphatic system disorders
    Anemia 0/30 (0%) 2/30 (6.7%)
    Heparin induced thrombocytopenia 0/30 (0%) 1/30 (3.3%)
    Cardiac disorders
    Cardiopulmonary event 0/30 (0%) 1/30 (3.3%)
    Atrial fibrillation 0/30 (0%) 1/30 (3.3%)
    Atrial flutter 1/30 (3.3%) 1 0/30 (0%) 1
    Pericarditis 1/30 (3.3%) 0/30 (0%)
    Supraventricular tachycardia 0/30 (0%) 2/30 (6.7%)
    Myocardial infarction 1/30 (3.3%) 0/30 (0%)
    Endocrine disorders
    Adrenal insufficiency 1/30 (3.3%) 0/30 (0%)
    Gastrointestinal disorders
    Pancreatitis 0/30 (0%) 1/30 (3.3%)
    Upper gastrointestinal hemorrhage 0/30 (0%) 2/30 (6.7%)
    General disorders
    Fatigue 1/30 (3.3%) 3/30 (10%)
    Immune system disorders
    Anaphylaxis 1/30 (3.3%) 0/30 (0%)
    Autoimmune hemolytic anemia 0/30 (0%) 1/30 (3.3%)
    Infections and infestations
    Lung infection 1/30 (3.3%) 8/30 (26.7%)
    Surgical wound infection 0/30 (0%) 1/30 (3.3%)
    Injury, poisoning and procedural complications
    Seroma 0/30 (0%) 1/30 (3.3%)
    Investigations
    Platelet count decreased 0/30 (0%) 1/30 (3.3%)
    Hyponatremia 1/30 (3.3%) 0/30 (0%)
    Alanine aminotransferase increased 0/30 (0%) 1/30 (3.3%)
    Aspartate aminotransferase increased 0/30 (0%) 1/30 (3.3%)
    Blood bilirubin increased 0/30 (0%) 1/30 (3.3%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma 0/30 (0%) 1/30 (3.3%)
    Nervous system disorders
    Stroke 1/30 (3.3%) 0/30 (0%)
    Presyncope 0/30 (0%) 1/30 (3.3%)
    Renal and urinary disorders
    Acute kidney injury 0/30 (0%) 1/30 (3.3%)
    Respiratory, thoracic and mediastinal disorders
    Aspiration 0/30 (0%) 1/30 (3.3%)
    Bronchopleural Fistula 1/30 (3.3%) 2/30 (6.7%)
    Bronchospasm 1/30 (3.3%) 0/30 (0%)
    Chylothorax 1/30 (3.3%) 0/30 (0%)
    Dyspnea 1/30 (3.3%) 2/30 (6.7%)
    Pneumothorax 1/30 (3.3%) 0/30 (0%)
    Respiratory failure 0/30 (0%) 1/30 (3.3%)
    Pneumonitis 2/30 (6.7%) 1/30 (3.3%)
    Vascular disorders
    Thromboembolic event 3/30 (10%) 5/30 (16.7%)
    Other (Not Including Serious) Adverse Events
    Arm 1 (Durvalumab Monotherapy) Arm 2 (Durvalumab Plus SBRT)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 29/30 (96.7%) 30/30 (100%)
    Blood and lymphatic system disorders
    Anemia 10/30 (33.3%) 16/30 (53.3%)
    Cardiac disorders
    Atrial fibrillation 2/30 (6.7%) 3/30 (10%)
    Endocrine disorders
    Hyperthyroidism 3/30 (10%) 1/30 (3.3%)
    Hypothyroidism 4/30 (13.3%) 0/30 (0%)
    Immune related thyroiditis 0/30 (0%) 2/30 (6.7%)
    Gastrointestinal disorders
    Constipation 20/30 (66.7%) 21/30 (70%)
    Nausea 9/30 (30%) 11/30 (36.7%)
    Diarrhea 10/30 (33.3%) 9/30 (30%)
    Vomiting 3/30 (10%) 5/30 (16.7%)
    Abdominal pain 2/30 (6.7%) 3/30 (10%)
    Colitis 2/30 (6.7%) 0/30 (0%)
    General disorders
    Fatigue 18/30 (60%) 14/30 (46.7%)
    Fever 3/30 (10%) 4/30 (13.3%)
    Chills 1/30 (3.3%) 4/30 (13.3%)
    Infusion related reaction 2/30 (6.7%) 3/30 (10%)
    Infections and infestations
    Urinary tract infection 3/30 (10%) 5/30 (16.7%)
    Investigations
    Lipase increased 8/30 (26.7%) 10/30 (33.3%)
    Serum amylase increased 6/30 (20%) 8/30 (26.7%)
    Hyperkalemia 5/30 (16.7%) 5/30 (16.7%)
    Hyperglycemia 2/30 (6.7%) 7/30 (23.3%)
    Hypoalbuminemia 2/30 (6.7%) 5/30 (16.7%)
    Alkaline phosphatase increased 1/30 (3.3%) 4/30 (13.3%)
    Aspartate aminotransferase increased 1/30 (3.3%) 3/30 (10%)
    Weight loss 2/30 (6.7%) 2/30 (6.7%)
    Hyponatremia 3/30 (10%) 0/30 (0%)
    Alanine aminotransferase increased 2/30 (6.7%) 1/30 (3.3%)
    Platelet count decreased 2/30 (6.7%) 1/30 (3.3%)
    Metabolism and nutrition disorders
    Anorexia 4/30 (13.3%) 7/30 (23.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/30 (6.7%) 5/30 (16.7%)
    Myalgia 1/30 (3.3%) 6/30 (20%)
    Back pain 3/30 (10%) 2/30 (6.7%)
    Generalized muscle weakness 0/30 (0%) 3/30 (10%)
    Nervous system disorders
    Dizziness 2/30 (6.7%) 4/30 (13.3%)
    Headache 3/30 (10%) 5/30 (16.7%)
    Presyncope 2/30 (6.7%) 2/30 (6.7%)
    Respiratory, thoracic and mediastinal disorders
    Cough 13/30 (43.3%) 13/30 (43.3%)
    Dyspnea 8/30 (26.7%) 12/30 (40%)
    Pneumothorax 4/30 (13.3%) 1/30 (3.3%)
    Wheezing 3/30 (10%) 2/30 (6.7%)
    Skin and subcutaneous tissue disorders
    Rash 5/30 (16.7%) 6/30 (20%)
    Pruritis 1/30 (3.3%) 6/30 (20%)
    Dry skin 2/30 (6.7%) 2/30 (6.7%)
    Vascular disorders
    Hypotension 8/30 (26.7%) 9/30 (30%)
    Hypertension 3/30 (10%) 3/30 (10%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Cathy Spinelli, RN BSN
    Organization Weill Cornell Medicine
    Phone 212-746-3328
    Email caf2007@med.cornell.edu
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT02904954
    Other Study ID Numbers:
    • 1501015795
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022