A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— ATLANTIC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02087423
• Other study ID #: D4191C00003
• Secondary ID: 2013-005427-16
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 25, 2014
• Est. completion date: June 28, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 446
• Est. completion date: June 28, 2024
• Est. primary completion date: June 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• MEDI4736
MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.

Locations

Country	Name	City	State
Austria	Research Site	Wien
Belgium	Research Site	Brussel
Belgium	Research Site	Gent
Belgium	Research Site	Gilly
Belgium	Research Site	Kortrijk
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Czechia	Research Site	Brno
Czechia	Research Site	Praha
Czechia	Research Site	Praha 5
Czechia	Research Site	Praha 8
France	Research Site	Bordeaux Cedex
France	Research Site	Brest Cedex
France	Research Site	Creteil
France	Research Site	Dijon
France	Research Site	Le Mans Cedex 02
France	Research Site	Marseille
France	Research Site	Pessac
France	Research Site	Rennes Cedex 09
France	Research Site	Saint Herblain Cedex
France	Research Site	Toulouse Cedex 9
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Borstel
Germany	Research Site	Dortmund
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Freiburg
Germany	Research Site	Grosshansdorf
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Köln
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Gyor
Hungary	Research Site	Szolnok
Hungary	Research Site	Tatabánya
Hungary	Research Site	Törökbálint
Italy	Research Site	Candiolo
Italy	Research Site	Catania
Italy	Research Site	Milano
Italy	Research Site	Monza
Italy	Research Site	Orbassano
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Rozzano
Japan	Research Site	Akashi-shi
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Habikino-shi
Japan	Research Site	Hidaka-shi
Japan	Research Site	Hirakata-shi
Japan	Research Site	Kashiwa
Japan	Research Site	Kitaadachi-gun
Japan	Research Site	Kobe-shi
Japan	Research Site	Koto-ku
Japan	Research Site	Kurume-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Natori-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osakasayama
Japan	Research Site	Sakai-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Sunto-gun
Japan	Research Site	Ube-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Goyang-si
Korea, Republic of	Research Site	Hwasun-gun
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Philippines	Research Site	Cebu City
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Philippines	Research Site	Quezon City
Poland	Research Site	Gdansk
Poland	Research Site	Warszawa
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Singapore	Research Site	Singapore
Spain	Research Site	Barcelona
Spain	Research Site	Gerona
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Sevilla
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Thailand	Research Site	Hat Yai
Thailand	Research Site	Muang
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Stoke-on-Trent
United States	Research Site	Bethesda	Maryland
United States	Research Site	Bismarck	North Dakota
United States	Research Site	Blue Ash	Ohio
United States	Research Site	Bronx	New York
United States	Research Site	Burlington	Massachusetts
United States	Research Site	Canton	Ohio
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fort Worth	Texas
United States	Research Site	Goodyear	Arizona
United States	Research Site	Huntersville	North Carolina
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Middletown	Ohio
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Port Saint Lucie	Florida
United States	Research Site	Saint Louis Park	Minnesota
United States	Research Site	Santa Rosa	California
United States	Research Site	Spokane	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Topeka	Kansas
United States	Research Site	Waterloo	Iowa
United States	Research Site	Wenatchee	Washington
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Philippines,  Poland,  Singapore,  Spain,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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 .	Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary	Time to Response (TTR)	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.	Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary	Duration of Response (DoR)	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.	Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
Secondary	Overall Survival (OS)	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.	From date of first treatment until final DCO (up to approximately 3 years 8 months)

External Links

•   AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com 1-877-400-4656
•   d4191c00003 revised csp 4 Redacted