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Trial record 3 of 67 for:    lung cancer | First posted from 01/01/2019 to 02/01/2019

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03800134
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 major pathological response.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Durvalumab Other: Placebo Drug: Carboplatin/Paclitaxel Drug: Cisplatin/Gemcitabine Drug: Pemetrexed/Cisplatin Drug: Pemetrexed/Carboplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : July 27, 2020
Estimated Study Completion Date : September 8, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy

Durvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:

  • carboplatin/paclitaxel
  • cisplatin/gemcitabine
  • pemetrexed/cisplatin
  • pemetrexed/carboplatin
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Name: MEDI4736

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care

Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care

Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy

Placebo in concurrence with platinum-based chemo-radiation therapy.

All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:

  • carboplatin/paclitaxel
  • cisplatin/gemcitabine
  • pemetrexed/cisplatin
  • pemetrexed/carboplatin
Other: Placebo
Placebo IV (intravenous infusion)

Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care

Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care

Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care

Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care




Primary Outcome Measures :
  1. Major Pathological Response (mPR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]

Secondary Outcome Measures :
  1. Pathological complete response (pCR) [ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]
  2. Overall Survival (OS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  3. Event-free survival (EFS) [ Time Frame: From date of randomization to 5.5 years after randomization ]
  4. Disease-free survival (DFS) [ Time Frame: From date of randomization to 5.5 years after date or resection ]
  5. To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]
  6. To assess the PK of durvalumab in blood (through concentration) [ Time Frame: From date of randomization to 2 months after resection ]
  7. Presence of ADA for durvalumab [ Time Frame: From date of randomization to 3 months after last dose of IP ]
  8. mPR in PD-L1-TC positive patients [ Time Frame: From screening pathology to an average of 15 weeks after first dose ]
  9. To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: From date of screening to 6 months after last dose of IP ]

Other Outcome Measures:
  1. Number of participants with all adverse events as assessed by CTCAE v4.0 in durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery [ Time Frame: 82 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • 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 patients tumour PD-L1 status
  • Documented EGFR and ALK status

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, 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
  • Mixed small cell and NSCLC histology
  • Patients who are candidates to undergo only segmentectomies or wedge resections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800134


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator 1-877-400-4656 astrazeneca@emergingmed.com

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Locations
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United States, Arizona
Research Site Not yet recruiting
Phoenix, Arizona, United States, 85054
United States, California
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Duarte, California, United States, 91010
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Orange, California, United States, 92868
United States, Florida
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Jacksonville, Florida, United States, 32256
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Tampa, Florida, United States, 33612
United States, Illinois
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Chicago, Illinois, United States, 60612
United States, Kansas
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Wichita, Kansas, United States, 67214
United States, Kentucky
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Lexington, Kentucky, United States, 40513
United States, Maryland
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Baltimore, Maryland, United States, 21204
Research Site Recruiting
Silver Spring, Maryland, United States, 20910
United States, Minnesota
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Duluth, Minnesota, United States, 55805
United States, New Jersey
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Summit, New Jersey, United States, 07901
United States, New York
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East Setauket, New York, United States, 11733
United States, North Carolina
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Durham, North Carolina, United States, 27710
Research Site Withdrawn
Salisbury, North Carolina, United States, 28144
United States, Oregon
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Bend, Oregon, United States, 97701
United States, Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
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Charleston, South Carolina, United States, 29424
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Texas
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Fort Worth, Texas, United States, 76104
Research Site Recruiting
Houston, Texas, United States, 77090
United States, Virginia
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Fort Belvoir, Virginia, United States, 22060
United States, Washington
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Kennewick, Washington, United States, 99336
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Seattle, Washington, United States, 98195
United States, West Virginia
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Morgantown, West Virginia, United States, 26506
Argentina
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Buenos Aires, Argentina, C1118AAT
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Caba, Argentina, 1280AEB
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Córdoba, Argentina, X5004BAL
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San Salvador de Jujuy, Argentina, 4600
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Santa Rosa, Argentina, 6300
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Viedma, Argentina, R8500ACE
Austria
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Feldkirch, Austria, 6807
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Wien, Austria, 1090
Chile
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Santiago de Chile, Chile, 6770128
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Santiago, Chile, 7520349
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Viña del Mar, Chile, 2540488
Hungary
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Budapest, Hungary, 1121
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Budapest, Hungary, 1125
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Győr, Hungary, 9024
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Mátraháza, Hungary, H-3233
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Törökbálint, Hungary, 2045
India
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Bangalore, India, 560068
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Gurgaon, India, 122001
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Kolkata, India, 700160
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Maharashtra, India, 411013
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Nagpur, India, 440012
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Nasik, India, 422002
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New Delhi, India, 110063
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New Delhi, India, 110085
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Vishakhapatnam, India, 530017
Japan
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Himeji-shi, Japan, 670-8520
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Iwakuni-shi, Japan, 740-8510
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Kitaadachi-gun, Japan, 362-0806
Research Site Recruiting
Kurashiki-shi, Japan, 701-0192
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Nagoya-shi, Japan, 464-8681
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Niigata-shi, Japan, 951-8566
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Okayama-shi, Japan, 700-8558
Research Site Recruiting
Wakayama-shi, Japan, 641-8510
Korea, Republic of
Research Site Recruiting
Busan, Korea, Republic of, 48108
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Cheongju-si, Korea, Republic of, 28644
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Incheon, Korea, Republic of, 21565
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Seongnam-si, Korea, Republic of, 13620
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Seoul, Korea, Republic of, 05505
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Seoul, Korea, Republic of, 06591
Mexico
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Aguascalientes, Mexico, 20230
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Guadalajara Jalisco, Mexico
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Monterrey, Mexico, 64000
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México, Mexico, 1400
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México, Mexico, 14050
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Pachuca de Soto, Mexico, 42090
Philippines
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Davao City, Philippines, 8000
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Makati, Philippines, 1229
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Manila, Philippines, 1015
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Quezon City, Philippines
Russian Federation
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Ekaterinburg, Russian Federation, 620905
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Krasnoyarsk, Russian Federation, 660133
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Moscow, Russian Federation, 105229
Research Site Not yet recruiting
Moscow, Russian Federation, 115008
Research Site Withdrawn
Moscow, Russian Federation, 115478
Research Site Withdrawn
Novosibirsk, Russian Federation, 630108
Research Site Withdrawn
Omsk, Russian Federation, 644013
Research Site Recruiting
Rostov-on-Don, Russian Federation, 344037
Research Site Withdrawn
Saint-Petersburg, Russian Federation, 194291
Research Site Not yet recruiting
St. Petersburg, Russian Federation, 197022
Research Site Withdrawn
Syktyvkar, Russian Federation, 167904
Research Site Withdrawn
Tomsk, Russian Federation, 634009
Taiwan
Research Site Not yet recruiting
Taichung, Taiwan, 402
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Taichung, Taiwan, 40705
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Tainan City, Taiwan, 701
Research Site Recruiting
Taipei, Taiwan, 10002
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Taipei, Taiwan, 110
Research Site Recruiting
Taipei, Taiwan, 235
Thailand
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Bangkok, Thailand, 10300
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Bangkok, Thailand, 10330
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Chiang Mai, Thailand, 50200
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Khon Kaen, Thailand, 40002
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Lampang, Thailand, 52000
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Muang, Thailand, 57000
Vietnam
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Hanoi, Vietnam, 100000
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Ho Chi Minh, Vietnam, 10000
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Ho Chi Minh, Vietnam, 700000
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Leonardo Trani, MD AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03800134     History of Changes
Other Study ID Numbers: D9106C00001
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Carboplatin
Pemetrexed
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents