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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03164616

This Phase III study evaluates the efficacy and safety of durvalumab + tremelimumab with chemotherapy, durvalumab with chemotherapy, or chemotherapy alone in metastatic NSCLC patients without EGFR/ALK mutations. Eligible patients are adults with Stage IV NSCLC, confirmed PD-L1 status, and no prior systemic therapy. Interventions include various chemotherapy regimens alongside durvalumab and tremelimumab.

Patient Parameters

Program Overview

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.

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.

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.

Locations

FACILITYZIPCITYSTATE
Research Site85054PhoenixArizona
Research Site93309BakersfieldCalifornia
Research Site90404Santa MonicaCalifornia
Research Site33901Fort MyersFlorida
Research Site32224JacksonvilleFlorida
Research Site33705St. PetersburgFlorida
Research Site33401West Palm BeachFlorida
Research Site40202LouisvilleKentucky
Research Site64132Kansas CityMissouri
Research Site44710CantonOhio

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