To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT06194448
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    80 mg daily (or 40 mg daily for dose reduction)
  • Cisplatin or Carboplatin; Pemetrexed or Paclitaxel — DRUG
    Pemetrexed (500 mg/m2 to be administered on Day 1 of every 3-week cycle for 2 cycles) or Paclitaxel (175 mg/m2 on Day 1 of every 3-week cycle for 2 cycles) PLUS Cisplatin (75 mg/m2) or Carboplatin (AUC5) to be administered on Day 1 of every 3--week cycle for 2 cycles
  • Radiation — DRUG
    Patients must have received a total dose of radiation of 60 Gy ± 10% (54 to 66 Gy) as part of the chemoradiation therapy. It is recommended but not required that patients have a: * Mean lung dose \< 20 Gy and/or V20 \< 35% * Mean oesophagus dose \< 34 Gy * Heart V50 \< 25%, V30 \< 50%, and V45 \< 35%

Study Details

The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent CRT and maintenance osimertinib in adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

Key Dates

Start date
Apr 21, 2024
Status verified
Jun 2026
Primary completion
Jul 7, 2026
Completion
Jul 7, 2027

Study Design

Enrollment
76 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label Osimertinib Induction Treatment
    Patients will receive open-label osimertinib induction treatment for 8 weeks (± 1 week window to account for patient variability and CRT scheduling), followed by CRT treatment for 6 weeks (± 1 week) and then osimertinib maintenance treatment until RECIST 1.1-defined radiological progression by investigator unless there is evidence of unacceptable toxicity or if the patient requests to stop the study treatment.

Primary Outcome Measure

PFS (Progression-Free Survival) [ Time Frame: Assessed from date of first dose to progression (up to a maximum of approximately 4 years) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SitePalo AltoCalifornia94304-

Find similar trials in La Jolla, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· La Jolla, CAResearch Site· Palo Alto, CA

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