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Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736) (ASTEROID)

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ClinicalTrials.gov Identifier: NCT03446547
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Andreas Hallqvist, Vastra Gotaland Region

Brief Summary:

This is a randomized multicentre open label phase II study of Durvalumab following Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC.

Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12 months


Condition or disease Intervention/treatment Phase
NSCLC, Stage I Drug: Durvalumab Phase 2

Detailed Description:
This is a randomized multicentre open label phase II study of the PDL1 inhibitor Durvalumab following SBRT in patients with T1-2N0M0 NSCLC. It will enroll 216 patients aiming at a minimum of 5 subjects per site. The subjects will be randomized in a 1:1 fashion with performance status, gender and T-stage as stratification factors. Patients with peripheral lung tumors will receive SBRT usually between 3 and 4 fractions. The group randomized to immunotherapy will then receive Durvalumab, given with a fixed dose of 1500 mg i.v. every fourth week during 12 months. Both arms will be assessed according to the same follow-up schedule with radiology every third month.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736). An Open Label Randomized Phase II Trial With Durvalumab Following Stereotactic Body Radiotherapy (SBRT) in Patients With Stage I Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
No Intervention: Arm A
SBRT and follow-up
Experimental: Arm B
SBRT followed by Durvalumab
Drug: Durvalumab
durvalumab 1500 mg i.v. every fourth week for 12 months
Other Name: Medi4736




Primary Outcome Measures :
  1. TTP [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]
    Time to progression


Secondary Outcome Measures :
  1. OS [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    Overall survival

  2. LC [ Time Frame: Assessed at scheduled timepoints every 3-6 months through study completion (60 months) ]
    Local control

  3. QoL [ Time Frame: Measured at baseline and at three timepoints (6, 12 and 20 months) ]
    QoL by LCSS

  4. TTP by PDL1 expression [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]
    Time to progression related to level of PDL1expression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening evaluations
  • Histological or cytological diagnosis of NSCLC
  • Stage I-IIA tumours ≤ 5 cm
  • Peripheral tumours
  • Medically inoperable patients or patients refusing surgery
  • Received no prior chemotherapy or radiation therapy for NSCLC
  • Age > 18 years at time of study entry, no upper age limit
  • WHO performance status 0-2
  • 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)
  • AST/ALT ≤ 2.5 x institutional upper limit of normal
  • Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by chrome-EDTA or Iohexol clearance
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects
  • 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

Exclusion Criteria:

  • Centrally located tumours
  • No regional or distant metastases are allowed (i.e. no stage II-IV disease)
  • Oxygen usage or a FEV1 < 0.7 L and CO diffusion capacity < 30%
  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study
  • Participation in another clinical study with an investigational product during the last 4 weeks
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
  • Second primary residual malignancy. Other malignancy diagnosed and treated > 5 years ago without relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin < 5 years are allowed)
  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
  • 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 14 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
  • Active or prior documented autoimmune or inflammatory disorders . The following are exceptions to this criterion:

    • Subjects with vitiligo or alopecia
    • Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
    • Subjects with celiac disease controlled by diet alone
  • 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 (NYHA III-IV), uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses
  • 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). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab
  • Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446547


Contacts
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Contact: Andreas Hallqvist, PhD +46-31342 ext 7954 andreas.hallqvist@vgregion.se
Contact: Annika Baan +46-70 ext 0906097 annika.baan@vgregion.se

Locations
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Finland
Dept of Oncology Recruiting
Tampere, Finland
Contact: Tanja Skyttä         
Contact       tanja.skytta@pshp.fi   
Dept of Oncology Recruiting
Vaasa, Finland
Contact: Antti Jekunen         
Contact       antti.jekunen@vshp.fi   
Norway
Dept of Oncology Recruiting
Oslo, Norway
Contact: Åslaug Helland       AHH@ous-hf.no   
Dept of pulmonary medicine Recruiting
Tromsø, Norway
Contact: Nina Helbekkmo       Nina.Helbekkmo@unn.no   
Dept of Oncology Recruiting
Trondheim, Norway
Contact: Bjørn Henning Grønberg       bjorn.h.gronberg@ntnu.no   
Sweden
Dept of pulmonary medicine Recruiting
Gävle, Sweden
Contact: Hirsch Koyi       hirsh.koyi@regiongavleborg.se   
Dept. of Oncology Recruiting
Göteborg, Sweden
Contact: Andreas Hallqvist, PhD       andreas.hallqvist@vgregion.se   
Dept of pulmonary medicine Recruiting
Linköping, Sweden
Contact: Anders Wikström       anders.vikstrom@regionostergotland.se   
Sunderbyn Recruiting
Luleå, Sweden
Contact: Lina Lindberg         
Contact       lina.h.lindberg@norrbotten.se   
Dept of pulmonary medicine Recruiting
Lund, Sweden
Contact: Maria Planck, Ass. prof.       maria.planck@med.lu.se   
Dept of Oncology Recruiting
Stockholm, Sweden
Contact: Luigi De Petris, PhD       luigi.depetris@sll.se   
Dept. of Oncology Recruiting
Umeå, Sweden
Contact: Mikael Johansson, Ass. Prof.       mikael.b.johansson@umu.se   
Sponsors and Collaborators
Vastra Gotaland Region
AstraZeneca
Investigators
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Principal Investigator: Andreas Hallqvist, PhD Göteborg University
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Responsible Party: Andreas Hallqvist, Principal Investigator, Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03446547    
Other Study ID Numbers: 2016-005225-37
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will be available later on

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andreas Hallqvist, Vastra Gotaland Region:
SBRT
Immunotherapy
Additional relevant MeSH terms:
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Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents