Brief Summary
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
Brief Title
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Detailed Description
This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), 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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Non-Small Cell Lung Cancer
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 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)
* 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)
Inclusion 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 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))
* 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))
Gender
All
Gender Based
false
Keywords
Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
130 Years
Minimum Age
18 Years
NCT Id
NCT02087423
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D4191C00003
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
Outcome Measure
Objective Response Rate (ORR)
Outcome Time Frame
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary Ids
Secondary Id
2013-005427-16
Secondary Outcomes
Outcome Description
TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.
Outcome Time Frame
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Outcome Measure
Time to Response (TTR)
Outcome Description
DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC\>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC \<25%); therefore the DoR "number of participants analyzed" field has been entered as "0" and the DoR results field has been left blank.
Outcome Time Frame
Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
Outcome Measure
Duration of Response (DoR)
Outcome Description
OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.
Outcome Time Frame
From date of first treatment until final DCO (up to approximately 3 years 8 months)
Outcome Measure
Overall Survival (OS)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
130
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404