Clinical Trials /

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

NCT03794544

Description:

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: D9108C00002
  • NCT ID: NCT03794544

Conditions

  • Resectable
  • Early-stage
  • NSCLC

Interventions

DrugSynonymsArms
DurvalumabArm A: Durvalumab monotherapy

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Arm A: Durvalumab monotherapyExperimentaldurvalumab IV
  • Durvalumab
Arm B: Durvalumab + OleclumabExperimentaldurvalumab IV and oleclumab IV
    Arm C: Durvalumab + MonalizumabExperimentaldurvalumab IV and monalizumab IV
      Arm D: Durvalumab + DanvatirsenExperimentaldanvatirsen IV and durvalumab IV

        Eligibility 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
              
        Maximum Eligible Age:102 Years
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure: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.
        Safety Issue:
        Description:Assess the antitumor activity of durvalumab alone and/or in combination with novel agents

        Secondary Outcome Measures

        Measure: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.
        Safety Issue:
        Description:Assess the feasibility of receiving the planned surgical resection
        Measure:AEs and SAEs
        Time Frame:Up to 126 days after C1D1
        Safety Issue:
        Description:Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents
        Measure: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.
        Safety Issue:
        Description:Assess the antitumor activity of durvalumab alone and/or in combination with novel agents
        Measure:Concentration of durvalumab or novel agents in plasma or serum.
        Time Frame:Up to 126 days after C1D1
        Safety Issue:
        Description:To describe the PK of durvalumab alone and/or in combination with novel agents
        Measure:ADA incidence of durvalumab or novel biologic agents.
        Time Frame:Up to 126 days after C1D1
        Safety Issue:
        Description:To assess the immunogenicity of durvalumab alone or in combination with novel agents To assess the immunogenicity of novel biologic agents in combination with durvalumab

        Details

        Phase:Phase 2
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:MedImmune LLC

        Trial Keywords

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

        Last Updated