A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT04351555
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Oral
  • Cisplatin — DRUG
    Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
  • Carboplatin — DRUG
    Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
  • Placebo — DRUG
    Oral
  • Pemetrexed — DRUG
    Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles

Study Details

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Key Dates

Start date
Dec 16, 2020
Status verified
Apr 2026
Primary completion
Oct 15, 2024
Completion
Jun 13, 2029

Study Design

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

Arms

  • Placebo Comparator: Arm 1: Placebo with platinum-based chemotherapy
    Placebo plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
  • Experimental: Arm 2: Osimertinib with platinum-based chemotherapy
    Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator) plus investigator's choice of platinum-based standard of care chemotherapy (pemetrexed/carboplatin or pemetrexed/cisplatin)
  • Experimental: Arm 3: Osimertinib monotherapy
    Osimertinib 80 mg QD (Dose may be reduced to 40 mg QD at the discretion of the investigator)

Primary Outcome Measure

Major Pathological Response (MPR) - IASLC Method [ Time Frame: From date of randomization to an average of 12 weeks after the first dose ]

Locations (12)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteSan FranciscoCalifornia94143-
Research SiteSanta MonicaCalifornia90404-
Research SiteSanta RosaCalifornia95403-
Research SiteBostonMassachusetts02215-
Research SiteLebanonNew Hampshire03756-
Research SiteCommackNew York11725-
Research SiteNew YorkNew York10032-
Research SiteHoustonTexas77030-
Research SiteFairfaxVirginia22031-
Research SiteSeattleWashington98104-

Related coverage on Hipa.ai

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By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Duarte, CAResearch Site· Irvine, CAResearch Site· San Francisco, CAResearch Site· Santa Monica, CAResearch Site· Santa Rosa, CAResearch Site· Boston, MA

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