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A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

NCT04765059 · COMPEL Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
98 (actual)
Start date
12 Sep 2021
Primary completion
28 Oct 2024 (actual)
Study completion
2 Jun 2027
Last update posted
7 Jul 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin Drug
  • Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin Drug

Conditions and primary outcome

  • Non-small Cell Lung Cancer

Primary outcome

Progression Free Survival (PFS) (From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04765059 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression Free Survival (PFS)

    Time frame
    From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
    Measure
    Median
    Unit
    Months

    • Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin vs Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or CarboplatinOther

      Efficacy comparison: Treatment A vs Treatment B

      Estimate
      0.43Hazard Ratio (HR)
      95% CI, two-sided
      0.27 to 0.70
      p-value
      Not given
      Method
      Log Rank

Serious adverse events

Time frame: From date of first dose (Day 1) until Follow-up (28 days post last dose) (up to 3 years 1 month)

Participants with serious adverse events per group for COMPEL, as posted
GroupAffectedAt risk
Treatment Arm A: Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin1848
Treatment Arm B: Placebo for Osimertinib (AZD9291), Pemetrexed, Cisplatin or Carboplatin1548

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT04765059.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.