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A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ATLANTIC)

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ClinicalTrials.gov Identifier: NCT02087423
Recruitment Status : Active, not recruiting
First Posted : March 14, 2014
Results First Posted : January 3, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 14, 2014
Results First Submitted Date  ICMJE June 3, 2017
Results First Posted Date  ICMJE January 3, 2018
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE February 25, 2014
Actual Primary Completion Date June 3, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
Objective Response Rate (ORR) [ Time Frame: Responses recorded during initial 12 month treatment period (up to primary analysis DCO) ]
Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Objective response rate (ORR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ]
Change History Complete list of historical versions of study NCT02087423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • Time to Response (TTR) [ Time Frame: Responses recorded during initial 12 month treatment period (up to primary analysis DCO) ]
    TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.
  • Duration of Response (DoR) [ Time Frame: Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO) ]
    DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC <25%); therefore the DoR "number of participants analyzed" field has been entered as "0" and the DoR results field has been left blank.
  • Overall Survival (OS) [ Time Frame: From date of first treatment until final DCO (up to approximately 3 years 8 months) ]
    OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Duration of response (DoR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ]
  • Progression Free survival (PFS) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ]
  • Disease control rate (DCR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ]
  • Overall Survival (OS, death due to any cause) [ Time Frame: Screening up to 2 years ]
  • Deep sustained response (DSR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ]
  • Levels of Anti-Drug Antibody (ADA) in patients treated with MEDI4736 [ Time Frame: Day 1 up to 2 years ]
  • Levels of tumoural expression of PD-L1 [ Time Frame: Screening up to 2 years ]
  • Adverse Events [ Time Frame: Screening up to 2 years ]
  • Vital signs (blood pressure and pulse) [ Time Frame: Screening up to 2 years ]
  • Electrocardiograms [ Time Frame: Screening up to 2 years ]
  • Physical examinations [ Time Frame: Screening up to 2 years ]
  • Laboratory findings (clinical chemistry, haematology) [ Time Frame: Screening up to 2 years ]
  • Laboratory findings (urinalysis) [ Time Frame: Screening up to 2 years ]
  • Concentration of MEDI4736 in blood and non compartmental PK parameters (peak) [ Time Frame: Day 1 up to 2 years ]
  • Concentration of MEDI4736 in blood and non compartmental PK parameters (trough) [ Time Frame: Day 1 up to 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Official Title  ICMJE A Phase II,Non-comparative,Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen
Brief Summary A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
Detailed Description This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: MEDI4736
MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.
Study Arms  ICMJE Experimental: MEDI4736
see below
Intervention: Drug: MEDI4736
Publications * Garassino MC, Cho BC, Kim JH, Mazières J, Vansteenkiste J, Lena H, Corral Jaime J, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Huang Y, Wadsworth C, Dennis PA, Rizvi NA; ATLANTIC Investigators. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X. Epub 2018 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2017)
446
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
210
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date June 3, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged at least 18 years.
  • Documented evidence of NSCLC (stage IIIB/IV disease)
  • Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
  • World Health Organisation (WHO) Performance Status of 0 or 1
  • Estimated life expectancy of more than 12 weeks
  • Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  • Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
  • Active or prior autoimmune disease or history of immunodeficiency
  • Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  • Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
  • Any unresolved toxicity CTCAE >Grade 2 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
  • Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Philippines,   Poland,   Singapore,   Spain,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Malaysia
 
Administrative Information
NCT Number  ICMJE NCT02087423
Other Study ID Numbers  ICMJE D4191C00003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phillip Dennis, MD, PhD AstraZeneca
PRS Account AstraZeneca
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP