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Clinical Trials/EUCTR2014-000338-46-ES
EUCTR2014-000338-46-ES
Active, not recruiting
Not Applicable

A Phase III, Open label, Randomised, Multi-centre, International Study of MEDI4736, versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC) - ARCTIC

AstraZeneca AB0 sites770 target enrollmentAugust 6, 2014
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Conditionsocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGemcitabine 38mg/ml powder for solution for infusionVinorelbine 10mg/ml concentrate for solution for infusionTarceva 25 mg film-coated tabletsTarceva 100 mg film-coated tablets

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
Sponsor
AstraZeneca AB
Enrollment
770
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 6, 2014
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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 regimen and at least 1 additional regimen for treatment of NSCLC
  • •\- World Health Organization (WHO) Performance Status of 0 or 1
  • •\- Estimated life expectancy more than 12 weeks
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 616
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Prior exposure to any anti\-PD\-1 or anti\-PD\-L1 antibody
  • •\- Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
  • •\- Active or prior documented autoimmune disease within the past 2 years
  • •\- Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV
  • •\- Any unresolved toxicity CTCAE \>Grade 2 from previous anti\-cancer therapy
  • •\- Known EGFR TK activating mutations or ALK rearrangements
  • •\- 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)

Outcomes

Primary Outcomes

Not specified

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A Phase III Study of MEDI4736 versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancerocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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