Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemother… (NCT03164616) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
United States1,186 participantsStarted 2017-06-01
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression-Free Survival (PFS); D + SoC Compared With SoC Alone
Timeframe: Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
2
Overall Survival (OS); D + SoC Compared With SoC Alone
Timeframe: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).