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Clinical Trials/EUCTR2014-000338-46-GR
EUCTR2014-000338-46-GR
Active, not recruiting
Phase 1

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 enrollmentSeptember 3, 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 infusionNavelbine 10 mg / ml concentrate for solution for infusionTarceva 25 mg film-coated tabletsTarceva 100 mg film-coated tablets

Overview

Phase
Phase 1
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
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2014
End Date
TBD
Last Updated
2 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

Similar Trials

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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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