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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 : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date October 24, 2019
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date October 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03822351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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
  • 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
  • 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
  • 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
  • Serum durvalumab concentration levels [ Time Frame: From randomization up to 15 months after first treatment ]
    Pharmacokinetics of durvalumab
  • 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
  • Development of detectable anti-drug antibody (ADA) to durvalumab [ Time Frame: From randomization up to 15 months after first treatment ]
    Immunogenicity of durvalumab
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Official Title  ICMJE 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)
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Stage III Non-small Cell Lung Cancer
  • Unresectable
Intervention  ICMJE
  • Drug: Durvalumab + Oleclumab
    Durvalumab + Oleclumab
    Other Names:
    • Durvalumab (MEDI-4736)
    • Oleclumab (MEDI-9447)
  • Drug: Durvalumab
    Durvalumab
    Other Name: Durvalumab (MEDI-4736)
  • Drug: Durvalumab + Monalizumab
    Durvalumab + Monalizumab
    Other Names:
    • Durvalumab (MEDI-4736)
    • Monalizumab (IPH2201)
Study Arms  ICMJE
  • Experimental: Control Arm (Durvalumab monotherapy)
    durvalumab IV
    Intervention: Drug: Durvalumab
  • Experimental: Arm A (durvalumab + oleclumab):
    durvalumab IV and oleclumab IV
    Intervention: Drug: Durvalumab + Oleclumab
  • Experimental: Arm B (durvalumab + monalizumab)
    durvalumab IV and monalizumab IV
    Intervention: Drug: Durvalumab + Monalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2023
Estimated Primary Completion Date October 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 42 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. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
  4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
  5. Subjects with a history of venous thrombosis within the past 3 months
  6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
  7. Congestive heart failure
  8. Active or prior documented autoimmune or inflammatory disorders
  9. History of active primary immunodeficiency
  10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
  11. History of allogenic organ transplantation
  12. QTcF interval ≥ 470 ms
  13. History of another primary malignancy
  14. Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
  15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries  ICMJE Canada,   France,   Hong Kong,   Italy,   Poland,   Portugal,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822351
Other Study ID Numbers  ICMJE D9108C00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP