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Trial record 10 of 13 for:    monalizumab

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03794544
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Brief Summary:
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Resectable Early-stage NSCLC Drug: Durvalumab Combination Product: Durvalumab + Oleclumab Combination Product: Durvalumab + Monalizumab Combination Product: Durvalumab + Danvatirsen Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be enrolled and randomized into a durvalumab monotherapy arm or into a durvalumab plus other novel therapy arms. Up to approximately 25 sites globally will participate in this study. New treatment arms may be added in the future. Subjects will be treated with a single durvalumab dose alone or in combination with other agents. After the single cycle treatment period patients will have the standard surgical resection planned. All subjects will have a post-resection monitoring visit. Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other investigators' reasons.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)
Actual Study Start Date : March 8, 2019
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : January 13, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Arm A: Durvalumab monotherapy
durvalumab IV
Drug: Durvalumab
Durvalumab

Experimental: Arm B: Durvalumab + Oleclumab
durvalumab IV and oleclumab IV
Combination Product: Durvalumab + Oleclumab
Durvalumab + Oleclumab

Experimental: Arm C: Durvalumab + Monalizumab
durvalumab IV and monalizumab IV
Combination Product: Durvalumab + Monalizumab
Durvalumab + Monalizumab

Experimental: Arm D: Durvalumab + Danvatirsen
danvatirsen IV and durvalumab IV
Combination Product: Durvalumab + Danvatirsen
Durvalumab + Danvatirsen




Primary Outcome Measures :
  1. Major Pathological Response rate [ Time Frame: Major Pathological Response will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period. ]
    Assess the antitumor activity of durvalumab alone and/or in combination with novel agents


Secondary Outcome Measures :
  1. Feasibility to surgery within the 14 days window period is a dichotomic variable: patients will have or will not have the tumor surgical resection done. [ Time Frame: Surgery is planned to take place within 14 days after the 4 weeks treatment period. ]
    Assess the feasibility of receiving the planned surgical resection

  2. AEs and SAEs [ Time Frame: Up to 126 days after C1D1 ]
    Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents

  3. Pathological Complete Response rate [ Time Frame: Pathological Complete Response will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period. ]
    Assess the antitumor activity of durvalumab alone and/or in combination with novel agents

  4. Concentration of durvalumab or novel agents in plasma or serum. [ Time Frame: Up to 126 days after C1D1 ]
    To describe the PK of durvalumab alone and/or in combination with novel agents

  5. ADA incidence of durvalumab or novel biologic agents. [ Time Frame: Up to 126 days after C1D1 ]
    1. To assess the immunogenicity of durvalumab alone or in combination with novel agents
    2. To assess the immunogenicity of novel biologic agents in combination with durvalumab



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Ages Eligible for Study:   18 Years to 102 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cytologically and/or histologically-documented NSCLC

    1. Stage I (> 2 cm) to IIIA (for subjects with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification
    2. Amenable to complete surgical resection
    3. Have not received any other therapy for this condition
  2. Age ≥18 years old
  3. Predicted FEV1 ≥ 50%
  4. Predicted DLCO ≥ 50%
  5. ECOG 0 or 1
  6. Adequate organ function

Exclusion Criteria:

  1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
  2. Subjects who require or may require pneumonectomy
  3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
  4. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
  5. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:

    1. Subjects with vitiligo or alopecia
    2. Subjects with hypothyroidism on hormone replacement
    3. Any chronic skin condition that does not require systemic therapy
    4. Subjects without active disease in the last 5 years may be included but only after consultation with the study physician
    5. Subjects with celiac disease controlled by diet alone
  6. Pregnant or breast-feeding female
  7. Major surgical procedure within prior 30 days
  8. History of active primary immunodeficiency
  9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
  10. QTc interval (QTc) ≥ 470 ms
  11. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent
  12. Receipt of live attenuated vaccination within 30 days prior to study entry
  13. History of another primary malignancy except for:

    1. Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
    2. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ

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): NCT03794544


Locations
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United States, California
Research Site
La Jolla, California, United States, 92093
United States, Florida
Research Site
Fort Myers, Florida, United States, 33901
Research Site
Leesburg, Florida, United States, 34748
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21231
United States, New York
Research Site
Buffalo, New York, United States, 14263
Research Site
New York, New York, United States, 10016
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37404
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H4A 3J1
France
Research Site
Marseille Cedex 9, France, 13009
Research Site
Toulouse CEDEX 09, France, 31059
Italy
Research Site
Orbassano, Italy, 10043
Portugal
Research Site
Porto, Portugal, 4200-072
Spain
Research Site
A Coruña, Spain, 15001
Research Site
Barcelona, Spain, 08916
Switzerland
Research Site
Zurich, Switzerland, 8091
Sponsors and Collaborators
MedImmune LLC
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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03794544    
Other Study ID Numbers: D9108C00002
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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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:
Neoadjuvant
Non-small Cell Lung Cancer
Cancer
Lung
Resectable
Early-stage
Stage I
Stage II
Stage IIIA
Durvalumab
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