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NCT02151981 · ClinicalTrials.gov registry record · Phase 3

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 3 study of Anticancer Treatment, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
421
Enrollment target
20
Study locations

NCT02151981: Completed Phase 3 study of Anticancer Treatment, sponsored by AstraZeneca.

NCT02151981 is a Phase 3 study of Anticancer Treatment that has completed, run by AstraZeneca. The registered enrollment target is 421 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02151981, a Phase 3 study of Anticancer Treatment, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
421 participants
Enrollment target
20
Study locations

Study Summary

A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

Primary Outcome

Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised

Conditions Studied

Interventions

  • DRUG Chemotherapy
  • DRUG Cross-over to Osimertinib

Study Locations (20)

California

  • Research Site - Anaheim
  • Research Site - Orange
  • Research Site - Santa Rosa

Florida

  • Research Site - Gainesville
  • Research Site - Orlando
  • Research Site - Pembroke Pines

Washington

  • Research Site - Lacey
  • Research Site - Tacoma

Connecticut

  • Research Site - Norwalk

Georgia

  • Research Site - Atlanta

Illinois

  • Research Site - Park Ridge

Indiana

  • Research Site - Indianapolis

Louisiana

  • Research Site - Marrero

Trial Details

FieldValue
Enrollment Target 421 participants
Start Date 2014-08-04
Est. Completion 2023-12-15
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02151981 record still lists

NCT02151981 is an interventional study that assigns participants to a tested intervention. The registered 421 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).

The record links to 1 condition, with Anticancer Treatment appearing as the primary indexed condition, and to 2 interventions - of which Chemotherapy is the first listed.

NCT02151981 names 20 study sites across 15 states, led by California, Florida, Washington.

Frequently Asked Questions

What is clinical trial NCT02151981 about?

NCT02151981 is a clinical study titled "AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer". A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumo...

What is the current status of trial NCT02151981?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 421 participants. The study started on 2014-08-04. Estimated completion is 2023-12-15.

What conditions does trial NCT02151981 study?

This clinical trial studies the following conditions: Anticancer Treatment.

What interventions are being tested in trial NCT02151981?

The interventions under investigation include: Chemotherapy (DRUG), Cross-over to Osimertinib (DRUG).

Who is sponsoring clinical trial NCT02151981?

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

Where is trial NCT02151981 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02151981's enrollment target sits among peer trials

421 890th of 2000 higher than 1,110 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT02151981, the US trial registry maintained by the National Library of Medicine. NCT02151981 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.