Non-Small Cell Lung Cancer Clinical Trial
— AEGEANOfficial title:
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
Verified date | May 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.
Status | Active, not recruiting |
Enrollment | 826 |
Est. completion date | September 11, 2028 |
Est. primary completion date | November 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: - Age =18 years - Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease - World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment - At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline - No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines - Adequate organ and marrow function - Confirmation of a patient's tumour PD-L1 status - Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status - Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy Exclusion Criteria: - History of allogeneic organ transplantation - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome) - History of another primary malignancy - History of active primary immunodeficiency - Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus - Deemed unresectable NSCLC by multidisciplinary evaluation - Patients who have pre-operative radiotherapy treatment as part of their care plan - Patients who have brain metastases or spinal cord compression - Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC - Known allergy or hypersensitivity to any of the study drugs or excipients - Existence of more than one primary tumour such as mixed small cell and NSCLC histology - Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections - Patients with a documented test result confirming the presence of EGFRm or ALK translocation |
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Buenos Aires | |
Argentina | Research Site | Caba | |
Argentina | Research Site | Caba | |
Argentina | Research Site | La Plata | |
Argentina | Research Site | Pergamino | |
Argentina | Research Site | Rosario | |
Argentina | Research Site | San Salvador de Jujuy | |
Argentina | Research Site | Viedma | |
Austria | Research Site | Graz | |
Austria | Research Site | Innsbruck | |
Austria | Research Site | Rankweil | |
Austria | Research Site | Wien | |
Austria | Research Site | Wien | |
Belgium | Research Site | Gent | |
Belgium | Research Site | Liège | |
Belgium | Research Site | Mons | |
Brazil | Research Site | Barretos | |
Brazil | Research Site | Belo Horizonte | |
Brazil | Research Site | Campinas | |
Brazil | Research Site | Curitiba | |
Brazil | Research Site | Florianópolis | |
Brazil | Research Site | Natal | |
Brazil | Research Site | Porto Alegre | |
Brazil | Research Site | Santa Maria | |
Brazil | Research Site | São José do Rio Preto | |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | São Paulo | |
Brazil | Research Site | Teresina | |
Brazil | Research Site | Vitoria | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Kitchener | Ontario |
Canada | Research Site | Levis | Quebec |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Quebec | |
Canada | Research Site | Saskatoon | Saskatchewan |
Chile | Research Site | Santiago | |
Chile | Research Site | Santiago | |
Chile | Research Site | Temuco | |
Chile | Research Site | Viña del Mar | |
China | Research Site | Beijing | |
China | Research Site | Beijing | |
China | Research Site | Beijing | |
China | Research Site | Beijing | |
China | Research Site | Changsha | |
China | Research Site | Changsha | |
China | Research Site | Changzhou | |
China | Research Site | Chengdu | |
China | Research Site | Guangzhou | |
China | Research Site | Guangzhou | |
China | Research Site | Guiyang | |
China | Research Site | Hangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hangzhou | |
China | Research Site | Hefei | |
China | Research Site | Kunming | |
China | Research Site | Linhai | |
China | Research Site | Nanchang | |
China | Research Site | Ningbo | |
China | Research Site | Shanghai | |
China | Research Site | Shanghai | |
China | Research Site | Shenyang | |
China | Research Site | Shenyang | |
China | Research Site | Shenzhen | |
China | Research Site | Shenzhen | |
China | Research Site | Tianjin | |
China | Research Site | Urumqi | |
China | Research Site | Wuhan | |
China | Research Site | Wuhan | |
China | Research Site | Xiamen | |
China | Research Site | Xintai | |
China | Research Site | Yangzhou | |
China | Research Site | Zhengzhou | |
Costa Rica | Research Site | San José | |
Costa Rica | Research Site | San José | |
France | Research Site | Avignon Cedex | |
France | Research Site | Lyon Cedex 08 | |
France | Research Site | Nice | |
France | Research Site | Toulon Cedex 9 | |
France | Research Site | Vantoux | |
Germany | Research Site | Bielefeld | |
Germany | Research Site | Frankfurt am Main | |
Germany | Research Site | Immenstadt | |
Germany | Research Site | Köln | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Gyöngyös - Mátraháza | |
Hungary | Research Site | Gyor | |
Hungary | Research Site | Székesfehérvár | |
Hungary | Research Site | Törökbálint | |
India | Research Site | Ahmedabad | |
India | Research Site | Gurgaon | |
India | Research Site | Gurgaon | |
India | Research Site | Kolkata | |
India | Research Site | Manipal | |
India | Research Site | Mumbai | |
India | Research Site | Mumbai | |
India | Research Site | Mysuru | |
India | Research Site | Namakkal | |
India | Research Site | Nashik | |
India | Research Site | New Delhi | |
India | Research Site | New Delhi | |
India | Research Site | Thane | |
India | Research Site | Vishakhapatnam | |
Italy | Research Site | Ancona | |
Italy | Research Site | Bari | |
Italy | Research Site | Bergamo | |
Italy | Research Site | Firenze | |
Italy | Research Site | Milano | |
Italy | Research Site | Monza | |
Italy | Research Site | Padova | |
Italy | Research Site | Roma | |
Italy | Research Site | Verona | |
Japan | Research Site | Habikino-shi | |
Japan | Research Site | Himeji-shi | |
Japan | Research Site | Hiroshima-shi | |
Japan | Research Site | Hiroshima-shi | |
Japan | Research Site | Iwakuni-shi | |
Japan | Research Site | Kitaadachi-gun | |
Japan | Research Site | Kitakyushu-shi | |
Japan | Research Site | Kurashiki shi | |
Japan | Research Site | Nagoya-shi | |
Japan | Research Site | Niigata-shi | |
Japan | Research Site | Okayama-shi | |
Japan | Research Site | Osakasayama-shi | |
Japan | Research Site | Toyoake-shi | |
Japan | Research Site | Wakayama-shi | |
Korea, Republic of | Research Site | Busan | |
Korea, Republic of | Research Site | Cheongju-si | |
Korea, Republic of | Research Site | Seongnam-si | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Seoul | |
Korea, Republic of | Research Site | Suwon | |
Korea, Republic of | Research Site | Suwon-si | |
Mexico | Research Site | Aguascalientes | |
Mexico | Research Site | Chihuahua | |
Mexico | Research Site | Guadalajara | |
Mexico | Research Site | México | |
Mexico | Research Site | México | |
Mexico | Research Site | Monterrey | |
Mexico | Research Site | Monterrey | |
Mexico | Research Site | Pachuca de Soto | |
Netherlands | Research Site | Arnhem | |
Netherlands | Research Site | Nijmegen | |
Peru | Research Site | Bellavista | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Philippines | Research Site | Davao City | |
Philippines | Research Site | Iloilo City | |
Philippines | Research Site | Makati | |
Philippines | Research Site | Quezon City | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Olsztyn | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Warszawa | |
Romania | Research Site | Suceava | |
Russian Federation | Research Site | Kazan | |
Russian Federation | Research Site | Krasnoyarsk | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nizhniy Novgorod | |
Russian Federation | Research Site | Obninsk | |
Russian Federation | Research Site | Rostov-on-Don | |
Russian Federation | Research Site | St. Petersburg | |
Russian Federation | Research Site | Tomsk | |
Russian Federation | Research Site | Yaroslavl | |
Spain | Research Site | Alicante | |
Spain | Research Site | Barcelona | |
Spain | Research Site | Madrid | |
Spain | Research Site | Málaga | |
Spain | Research Site | Oviedo | |
Spain | Research Site | Pamplona | |
Spain | Research Site | San Sebastian | |
Spain | Research Site | Santiago De Compostela (A Coruña) | |
Taiwan | Research Site | Changhua | |
Taiwan | Research Site | Taichung | |
Taiwan | Research Site | Taichung City | |
Taiwan | Research Site | Tainan City | |
Taiwan | Research Site | Tainan City | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taipei City | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Bangkok | |
Thailand | Research Site | Chiang Mai | |
Thailand | Research Site | Chiang Rai | |
Thailand | Research Site | Khon Kaen | |
Thailand | Research Site | Lampang | |
United States | Research Site | Ashland | Kentucky |
United States | Research Site | Aurora | Colorado |
United States | Research Site | Austin | Texas |
United States | Research Site | Bend | Oregon |
United States | Research Site | Boca Raton | Florida |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Duarte | California |
United States | Research Site | Duluth | Minnesota |
United States | Research Site | Durham | North Carolina |
United States | Research Site | Fairfax | Virginia |
United States | Research Site | Fort Worth | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | Kirkland | Washington |
United States | Research Site | Lexington | Kentucky |
United States | Research Site | Medford | Oregon |
United States | Research Site | Minneapolis | Minnesota |
United States | Research Site | Morristown | New Jersey |
United States | Research Site | New York | New York |
United States | Research Site | New York | New York |
United States | Research Site | Orange | California |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Seattle | Washington |
United States | Research Site | Shirley | New York |
United States | Research Site | Silver Spring | Maryland |
United States | Research Site | Towson | Maryland |
United States | Research Site | Wichita | Kansas |
Vietnam | Research Site | Hanoi | |
Vietnam | Research Site | Ho Chi Minh | |
Vietnam | Research Site | Ho Chi Minh | |
Vietnam | Research Site | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Vietnam, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, France, Germany, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Russian Federation, Spain, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with adverse events as assessed by CTCAE v5.0 | From date of randomization to 3 months after last dose of IP | ||
Primary | Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population | Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes. | Up to approximately 15 weeks after randomization | |
Primary | Event-Free Survival (EFS) in modified intent to treat (mITT) population | An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery. | Up to 5.5 years after first patient randomized. | |
Secondary | Disease-free survival (DFS) in modified resected population | From date of randomization to approximately 5.5 years after date of resection | ||
Secondary | Major Pathological Response (mPR) in modified intent to treat (mITT) population | Up to approximately 15 weeks after randomization | ||
Secondary | Overall Survival (OS) in modified intent to treat (mITT) population | From date of randomization to 5.5 years after randomization | ||
Secondary | Event-free survival (EFS) in PD-L1-TC =1% patients in modified intent to treat (mITT) population | From date of randomization to 5.5 years after randomization | ||
Secondary | pCR in PD-L1-TC =1% patients in modified intent to treat (mITT) population | Up to approximately 15 weeks after randomization | ||
Secondary | Disease-Free Survival (DFS) in PD-L1-TC =1% patients in modified resected population | From date of randomization to 5.5 years after date of resection | ||
Secondary | Major Pathological Response (mPR) in PD-L1-TC =1% patients in modified intent to treat (mITT) population | Up to approximately 15 weeks after randomization | ||
Secondary | Overall Survival (OS) in PD-L1-TC =1% patients in modified intent to treat (mITT) population | From date of randomization to 5.5 years after randomization. | ||
Secondary | To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | From date of screening to 6 months after last dose of IP | |
Secondary | To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery | To assess disease-related symptoms, functioning, and global health status/quality of life in patients. | From date of screening to 6 months after last dose of IP | |
Secondary | To assess the PK of durvalumab in blood | To assess concentration of durvalumab in bloodstream. | From date of randomization to 2 months after resection | |
Secondary | Presence of ADA for durvalumab | To evaluate the presence of antibodies following treatment with study medications. | From date of randomization to 3 months after last dose of IP |
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