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

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NCT04765059 · results posted

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Parexel.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
98actual
Sites
40
Countries
China, Germany, Israel +3

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-09-12actualWhen the study began enrolling
Primary completion2024-10-28actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2027-06-02estimatedThe whole study's end, after follow-up
First posted2021-02-21actualWhen this record first appeared on the registry
Results posted2026-01-13actualWhen the sponsor posted results to the registry
Record updated2026-07-07actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Non-small Cell Lung Cancer

Interventions

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

Primary outcome

what the primary-completion date above is the date OF
Progression Free Survival (PFS)
measured 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 documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2024-07-15 · 1.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-01-30 · 3.6 MB · SAP_001.pdf

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