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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:
ClinicalTrials.gov Identifier:
NCT02087423
First Posted: March 14, 2014
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Duration of response (DoR) 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 ]
  • Time to response (TTR) 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 ]
  • Overall Survival (OS, death due to any cause) [ 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 ]
  • Levels of Anti-Drug Antibody (ADA) in patients treated with MEDI4736 [ 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 ]

Enrollment: 444
Actual Study Start Date: February 25, 2014
Estimated Study Completion Date: October 31, 2017
Primary Completion Date: June 3, 2016 (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

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.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT02087423


  Show 119 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
First Submitted: March 4, 2014
First Posted: March 14, 2014
Last Update Posted: May 8, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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