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Trial record 1 of 1 for:    D9108C00001
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Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC (COAST)

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ClinicalTrials.gov Identifier: NCT03822351
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Condition or disease Intervention/treatment Phase
Stage III Non-small Cell Lung Cancer Unresectable Drug: Durvalumab + Oleclumab Drug: Durvalumab Drug: Durvalumab + Monalizumab Phase 2

Detailed Description:
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:

At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.

Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : October 23, 2023
Estimated Study Completion Date : October 23, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Control Arm (Durvalumab monotherapy)
durvalumab IV
Drug: Durvalumab
Durvalumab
Other Name: Durvalumab (MEDI-4736)

Experimental: Arm A (durvalumab + oleclumab):
durvalumab IV and oleclumab IV
Drug: Durvalumab + Oleclumab
Durvalumab + Oleclumab
Other Names:
  • Durvalumab (MEDI-4736)
  • Oleclumab (MEDI-9447)

Experimental: Arm B (durvalumab + monalizumab)
durvalumab IV and monalizumab IV
Drug: Durvalumab + Monalizumab
Durvalumab + Monalizumab
Other Names:
  • Durvalumab (MEDI-4736)
  • Monalizumab (IPH2201)




Primary Outcome Measures :
  1. Objective Response (OR) rate as a measure of antitumor activity of durvalumab alone vs durvalumab in combination with novel agents [ Time Frame: ORR at 16weeks after randomization is the timing for radiologic assessment of the primary endpoint ]
    Best overall response of confirmed CR or confirmed PR according to RECIST v1.1


Secondary Outcome Measures :
  1. Incidence of Adverse Events as a measure of safety during the treatment period [ Time Frame: From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment ]
    The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events

  2. Duration of Response (DoR) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents [ Time Frame: From time of first documented response until disease progression or up to a maximum of 5 years after randomization ]
    The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only subjects who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR

  3. Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents [ Time Frame: From time of randomization until disease progression or up to a maximum of 5 years ]
    confirmed CR, confirmed PR, or SD based on RECIST v1.1

  4. Progression-Free Survival (PFS) and Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents [ Time Frame: From time of randomization until disease progression or up to a maximum of 5 years ]
    From randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first

  5. Serum durvalumab concentration levels [ Time Frame: From randomization up to 15 months after first treatment ]
    Pharmacokinetics of durvalumab

  6. Serum concentration levels of durvalumab or novel agents [ Time Frame: From randomization up to 15 months after first treatment ]
    Pharmacokinetics of durvalumab alone and/or in combination with novel agents

  7. Development of detectable anti-drug antibody (ADA) to durvalumab [ Time Frame: From randomization up to 15 months after first treatment ]
    Immunogenicity of durvalumab

  8. Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents [ Time Frame: From randomization up to 15 months after first treatment ]
    Immunogenicity of durvalumab alone and/or in combination with novel biologic agents

  9. Number of patients with clinically significant laboratory values as a measure of safety [ Time Frame: From screening until disease progression or death, up to a maximum of 5 years after randomization ]
    Assess the presence of clinically significant laboratory values taken at times indicated in the assessment schedule from baseline in terms of number of patients with abnormal values

  10. Incidence of clinically significant vital sign values as a measure of safety [ Time Frame: From screening until disease progression or death, up to a maximum of 5 years after randomization ]
    Assess the presence of clinically significant vital sign values from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
  2. Age 18 years or older
  3. Body weight ≥ 35 kg
  4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
  5. Subjects must have completed, without progressing, definitive cCRT within 28 days prior to being randomized into the study:
  6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
  7. Life expectancy ≥ 12 weeks
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1

Main Exclusion Criteria:

  1. Mixed small cell and non-small cell lung cancer histology
  2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
  3. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
  4. Subjects with a history of venous thrombosis within the past 3 months
  5. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
  6. Congestive heart failure
  7. Active or prior documented autoimmune or inflammatory disorders
  8. History of active primary immunodeficiency
  9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  10. History of allogenic organ transplantation
  11. QTcF interval ≥ 470 ms
  12. History of another primary malignancy
  13. Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
  14. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study

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): NCT03822351


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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Sponsors and Collaborators
MedImmune LLC

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03822351     History of Changes
Other Study ID Numbers: D9108C00001
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 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 MedImmune LLC:
Locally Advanced NSCLC
Non-small Cell Lung Cancer
Cancer
Lung
Unresectable
Stage III
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
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs