Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment medi4736
Phase phase 2
Target PD-1
Sponsor AstraZeneca
Start date February 2014
End date June 2016
Trial size 1980 participants
Trial identifier NCT02087423, D4191C00003

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
see below
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.

Primary Outcomes

Measure
Objective response rate (ORR) using Independent Central Review assessments according to RECIST 1.1
time frame: Screening up to 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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)

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.