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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02087423
First received: March 4, 2014
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
A study to assess the Effects of MEDI4736 in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: MEDI4736
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Objective response rate (ORR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response (DoR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]
  • Disease control rate (DCR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]
  • Time to response (TTR) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]
  • Progression Free survival (PFS) using Independent Central Review assessments according to RECIST 1.1 [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS, death due to any cause) [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Vital signs (blood pressure and pulse) [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Electrocardiograms [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Physical examinations [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Laboratory findings (clinical chemistry, haematology) [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Laboratory findings (urinalysis) [ Time Frame: Screening up to 2 years ] [ Designated as safety issue: Yes ]
  • Concentration of MEDI4736 in blood and non compartmental PK parameters (peak) [ Time Frame: Day 1 up to 2 years ] [ Designated as safety issue: No ]
  • Levels of Anti-Drug Antibody (ADA) in patients treated with MEDI4736 [ Time Frame: Day 1 up to 2 years ] [ Designated as safety issue: No ]
  • Concentration of MEDI4736 in blood and non compartmental PK parameters (trough) [ Time Frame: Day 1 up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 1980
Study Start Date: February 2014
Estimated Study Completion Date: October 2017
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDI4736
see below
Drug: MEDI4736
MEDI4736 by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier.

Detailed Description:
This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736, 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
  Eligibility

Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087423

  Show 120 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Phillip Dennis, MD, PhD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02087423     History of Changes
Other Study ID Numbers: D4191C00003 
Study First Received: March 4, 2014
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Czech Republic: State Institute for Drug Control
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: ANSM, The French National Agency for Medicines and Health Products Safety
Philippines: Department of Health
Austria: Federal Office for Safety in Health Care
Italy: The Italian Medicines Agency
HUNGARY: OGYI, National Institute of Pharmacy
Singapore: Health Sciences Authority
SPAIN: Spanish Agency of Medicines and Medical Devices
TAIWAN: Food and Drug Administration, Department of Health, Executive Yuan
THAILAND: Food and Drug Administration Thailand (FDA Thailand)

Keywords provided by AstraZeneca:
Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, PD-L1

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016