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NCT03164616 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca.

Active
Registry status
Phase 3
Development phase
1,186
Enrollment target
20
Study locations

NCT03164616: Active Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by AstraZeneca.

NCT03164616 is a Phase 3 study of Non-small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,186 participants, above the 265-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (348% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03164616, a Phase 3 study of Non-small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,186 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

PFS (per RECIST version 1.1 \[RECIST 1.1\] using Blinded Independent Central Review \[BICR\] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-speci

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • DRUG Durvalumab
  • DRUG Tremelimumab
  • DRUG Abraxane + carboplatin
  • DRUG Gemcitabine + cisplatin
  • DRUG Gemcitabine + carboplatin

Study Locations (20)

Florida

  • Research Site - Fort Myers
  • Research Site - Jacksonville
  • Research Site - St. Petersburg
  • Research Site - West Palm Beach

Other

  • Research Site - Barretos
  • Research Site - Belo Horizonte
  • Research Site - Curitiba
  • Research Site - Porto Alegre

California

  • Research Site - Bakersfield
  • Research Site - Santa Monica

Tennessee

  • Research Site - Chattanooga
  • Research Site - Nashville

Texas

  • Research Site - Fort Worth
  • Research Site - Houston

Arizona

  • Research Site - Phoenix

Kentucky

  • Research Site - Louisville

Missouri

  • Research Site - Kansas City

Trial Details

FieldValue
Enrollment Target 1,186 participants
Start Date 2017-06-01
Est. Completion 2027-11-15
Phase Phase 3
AstraZeneca

1,285 total trials

What the registry record for NCT03164616 still lists

NCT03164616 is an interventional study that assigns participants to a tested intervention. Its 1,186 participants enrollment target places it among the larger protocols in the corpus, above the 265-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (348% higher).

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 5 interventions - of which Durvalumab is the first listed.

NCT03164616 names 20 study sites across 11 states, led by Florida, Other, California.

Frequently Asked Questions

What is clinical trial NCT03164616 about?

NCT03164616 is a clinical study titled "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 pa...

What is the current status of trial NCT03164616?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,186 participants. The study started on 2017-06-01. Estimated completion is 2027-11-15.

What conditions does trial NCT03164616 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT03164616?

The interventions under investigation include: Durvalumab (DRUG), Tremelimumab (DRUG), Abraxane + carboplatin (DRUG), Gemcitabine + cisplatin (DRUG), Gemcitabine + carboplatin (DRUG).

Who is sponsoring clinical trial NCT03164616?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03164616 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-small Cell Lung Cancer (NSCLC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03164616's enrollment target sits among peer trials

1,186 2nd of 59 the highest of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03164616, the US trial registry maintained by the National Library of Medicine. NCT03164616 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.