Clinical Trials /

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

NCT03164616

Description:

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
  • Official Title: A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)

Clinical Trial IDs

  • ORG STUDY ID: D419MC00004
  • NCT ID: NCT03164616

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Interventions

DrugSynonymsArms
DurvalumabTreatment Arm 1
TremelimumabTreatment Arm 1
Abraxane + carboplatinTreatment Arm 1
Gemcitabine + cisplatinTreatment Arm 1
Gemcitabine + carboplatinTreatment Arm 1
Pemetrexed + carboplatinTreatment Arm 1
Pemetrexed + cisplatinTreatment Arm 1

Purpose

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Detailed Description

      Adult patients with a histologically or cytologically documented metastatic NSCLC, with
      tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment.
      Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab +
      tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC
      chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until
      objective disease progression as efficacy assessment. All patients will be followed for
      survival until the end of the study. An independent data monitoring committee (IDMC)
      composed of independent experts will be convened to confirm the safety and tolerability of
      the proposed dose and schedule.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment Arm 1Experimentaldurvalumab + tremelimumab comination therapy + SoC chemotherapy
  • Durvalumab
  • Tremelimumab
  • Abraxane + carboplatin
  • Gemcitabine + cisplatin
  • Gemcitabine + carboplatin
  • Pemetrexed + carboplatin
  • Pemetrexed + cisplatin
Treatment Arm 2Experimentaldurvalumab monotherapy + SoC chemotherapy
  • Durvalumab
  • Abraxane + carboplatin
  • Gemcitabine + cisplatin
  • Gemcitabine + carboplatin
  • Pemetrexed + carboplatin
  • Pemetrexed + cisplatin
Treatment Arm 3Active ComparatorSoC chemotherapy alone
  • Abraxane + carboplatin
  • Gemcitabine + cisplatin
  • Gemcitabine + carboplatin
  • Pemetrexed + carboplatin
  • Pemetrexed + cisplatin

Eligibility Criteria

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          1. Aged at least 18 years.

          2. Histologically or cytologically documented Stage IV NSCLC.

          3. Confirmed tumor PD-L1 status prior to randomization.

          4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.

          5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.

          6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
             status of 0 or 1.

          7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer
             vaccines.

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.

          2. Active or prior documented autoimmune or inflammatory disorders.

          3. Brain metastases or spinal cord compression unless the patient's condition is stable
             and off steroids.

          4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human
             immunodeficiency virus.
      
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS) using BICR assessments according to RECIST 1.1
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Overall survival (OS)
Time Frame:Up to 4 years after first patient randomized
Safety Issue:
Description:
Measure:Objective response rate (ORR) using BICR assessments according to RECIST 1.1
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Duration of response (DoR) using BICR assessments according to RECIST 1.1
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Time from randomization to second progression (PFS2)
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Proportion of patients alive and progression free at 12 months from randomization (APF12) using BICR assessments according to RECIST 1.1
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Best objective response (BoR) using BICR assessments according to RECIST 1.1
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by concentration
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:The immunogenicity of durvalumab and tremelimumab as assessed by presence of anti-drug antibodies (ADAs)
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Health-related QoL measured by EORTC QLQ-C30 v3
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Disease-related symptoms measured by EORTC QLQ-LC13
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:
Measure:Changes in WHO/ECOG performance status
Time Frame:Up to 3 years after first patient randomized
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • NSCLC
  • PD-L1
  • Durvalumab
  • Tremelimumab
  • PFS

Last Updated

May 22, 2017