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

NCT03164616

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non Small Cell Lung Cancer NSCLC

Interventions: Durvalumab, Tremelimumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin

Countries: United States, Brazil, Bulgaria, China, Germany, Hong Kong, Hungary, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 (175)
  • Phoenix, Arizona, United States
  • Bakersfield, California, United States
  • Santa Monica, California, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • St. Petersburg, Florida, United States
  • West Palm Beach, Florida, United States
  • Louisville, Kentucky, United States
  • Kansas City, Missouri, United States
  • Canton, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • Richmond, Virginia, United States
  • Barretos, Brazil
  • Belo Horizonte, Brazil
  • Curitiba, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Ribeirão Preto, Brazil
  • Rio de Janeiro, Brazil
  • Santo André, Brazil
  • Santo André, Brazil
  • São José do Rio Preto, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • + 145 more on CT.gov