A Phase III Study of MEDI4736, given as Monotherapy or in Combination with Tremelimumab, versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 1

• Conditions: ocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV); MedDRA version: 20.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000338-46-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-30
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1300

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1040
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

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 acute or chronic hepatitis B, C and HIV
- Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
- Known EGFR TK activating mutations or ALK rearrangements. Patients with EGFR TK inactivating mutations eg, exon 20, are eligible.
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified