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

Part of paid clinical trials in Silver Spring, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04765059
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.

Key Dates

Start date
Sep 12, 2021
Status verified
Mar 2026
Primary completion
Oct 28, 2024
Completion
Jun 2, 2027

Study Design

Enrollment
98 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm A
    All randomized patients will receive osimertinib 80 mg QD with pemetrexed (500 mg/m\^2) (with pre-treatment) plus either cisplatin (75 mg/m\^2) or carboplatin (\[AUC\] 5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by osimertinib 80 mg QD plus pemetrexed maintenance (500 mg/m\^2) on Day 1 of 21-day cycles
  • Placebo Comparator: Treatment Arm B
    All randomized patients will receive placebo QD with pemetrexed (500 mg/m\^2) (with pre-treatment) plus either cisplatin (75 mg/m\^2) or carboplatin (AUC5), both administered on Day 1 of 21-day cycles for 4 cycles, followed by placebo QD plus pemetrexed maintenance (500 mg/m\^2) on Day 1 of 21-day cycles

Primary Outcome Measure

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) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteSilver SpringMaryland20910-
Research SiteBostonMassachusetts02114-

Related coverage on Hipa.ai

Find similar trials in Silver Spring, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Silver Spring, MDResearch Site· Boston, MA

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