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NCT02296125 · ClinicalTrials.gov registry record · Phase 3

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
674
Enrollment target

NCT02296125: Completed Phase 3 study, sponsored by AstraZeneca.

NCT02296125 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 674 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02296125, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
674 participants
Enrollment target

Study Summary

To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

Primary Outcome

Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment.

Interventions

  • DRUG AZD9291 80 mg/40 mg + placebo
  • DRUG Placebo Erlotinib 150/100mg
  • DRUG Placebo Gefitinib 250 mg
  • DRUG Erlotinib 150/100 mg
  • DRUG Gefitinib 250 mg

Trial Details

FieldValue
Enrollment Target 674 participants
Start Date 2014-12-03
Est. Completion 2025-11-20
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT02296125 record still lists

NCT02296125 is an interventional study that assigns participants to a tested intervention. The registered 674 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 (13% lower).

The record links to 0 conditions, and to 5 interventions - of which AZD9291 80 mg/40 mg + placebo is the first listed.

NCT02296125 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02296125 about?

NCT02296125 is a clinical study titled "AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer". To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer

What is the current status of trial NCT02296125?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2014-12-03. Estimated completion is 2025-11-20.

What interventions are being tested in trial NCT02296125?

The interventions under investigation include: AZD9291 80 mg/40 mg + placebo (DRUG), Placebo Erlotinib 150/100mg (DRUG), Placebo Gefitinib 250 mg (DRUG), Erlotinib 150/100 mg (DRUG), Gefitinib 250 mg (DRUG).

Who is sponsoring clinical trial NCT02296125?

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

How this trial's enrollment target compares

Where NCT02296125's enrollment target sits among peer trials

674 543rd of 2000 higher than 1,457 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 NCT02296125, the US trial registry maintained by the National Library of Medicine. NCT02296125 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.