Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
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.
- 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 & Contacts
Name Not Available
Contact: Sandra Hernandez
Name Not Available
Trial Objectives and Outline
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 Phase & Type
AstraZeneca Pharmaceuticals LP
Secondary IDs NCI-2017-02015
Clinicaltrials.gov ID NCT03164616