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

Running, not enrolling · Phase 3

Conditions studied: Non Small Cell Lung Cancer NSCLC

In brief

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.

Key facts

Study ID

NCT03164616

Run by

AstraZeneca

People needed

1186

Starts

2017-06-01

Expected to finish

2027-11-15

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study, patients should fulfill the following criteria:
• Aged at least 18 years.
• Histologically or cytologically documented Stage IV NSCLC.
• Confirmed tumor PD-L1 status prior to randomization.
• Patients must have tumors that lack activating EGFR mutations and ALK fusions.
• No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.

You may not qualify if…

• Patients should not enter the study if any of the following exclusion criteria are fulfilled:
• Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
• Active or prior documented autoimmune or inflammatory disorders.
• Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Where it is running

• Research Site — Bakersfield, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — Canton, Ohio, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Chattanooga, Tennessee, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Barretos, Brazil
• Research Site — Belo Horizonte, Brazil
• Research Site — Curitiba, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Ribeirão Preto, Brazil
• Research Site — Rio de Janeiro, Brazil
• Research Site — Santo André, Brazil
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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