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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 Cancer

Phase 1
Conditions
ocally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 17.0Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864
MedDRA version: 17.0Level: LLTClassification code 10066490Term: Progression of non-small cell lung cancerSystem Organ Class: 100000004864
Registration Number
EUCTR2014-000338-46-GR
Lead Sponsor
AstraZeneca AB
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
770
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
F.1.3.1 Number of subjects for this age range 154

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)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: To assess the efficacy of MEDI4736 treatment compared with Standard of Care in terms of Overall survival (OS) and Progression free survival (PFS).;Secondary Objective: To assess the efficacy of MEDI4736 compared with Standard of Care in terms of: Proportion of patients alive at 12 months from randomisation (OS12), Objective response rate (ORR), Duration of response (DoR);Primary end point(s): - Overall survival (OS) <br>- Progression free survival (PFS);Timepoint(s) of evaluation of this end point: - OS: up to 3 years after first patient randomized<br>- PFS: up to 3 years after first patient randomized
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): - Proportion of patients alive at 12 months from randomisation (OS12)<br>- Objective response rate (ORR)<br>- Duration of response (DoR)<br>;Timepoint(s) of evaluation of this end point: - OS12: up to 1 year after last patient randomized<br>- ORR: up to 3 years after the first patient randomized<br>- DoR: up to 3 years after the first patient randomized
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