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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: February 11, 2017
Last verified: February 2017
  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: No masking
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: 1980
Study Start Date: February 2014
Estimated Study Completion Date: October 2017
Primary Completion Date: June 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

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
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 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
Study First Received: March 4, 2014
Last Updated: February 11, 2017

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

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

ClinicalTrials.gov processed this record on April 27, 2017