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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    1193
  • sponsor
    AstraZeneca
Updated on 4 June 2021

Summary

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.

Details
Condition Non Small Cell Lung Cancer NSCLC
Treatment tremelimumab, durvalumab, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin, Abraxane + carboplatin
Clinical Study IdentifierNCT03164616
SponsorAstraZeneca
Last Modified on4 June 2021

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