Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

Conditions

• Epidermal Growth Factor Receptor Gene Mutation
• Non Small Cell Lung Cancer
• Stage III Lung Cancer
• Stage IV Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Osimertinib — DRUG
  Single agent Osimertinib by mouth once daily. Dosing and administration of osimertinib will be administered as per routine standard of care per the package insert or per institutional guidelines.
• Osimertinib + Chemotherapy — DRUG
  Osimertinib by mouth once daily + Chemotherapy. Chemotherapy choice will be per treating physician. Dosing and administration of osimertinib +/- chemotherapy agents will be administered as per routine standard of care per the package insert or per institutional guidelines.

Study Details

The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.

Key Dates

Start date

Sep 17, 2024

Status verified

Mar 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2029

Study Design

Enrollment

538 participants (estimated)

Arms

• Arm: Group 1
  Osimertinib
• Arm: Group 2
  Osimertinib + Chemotherapy

Primary Outcome Measure

real-world Progression-Free Survival (rwPFS) [ Time Frame: From initiation of therapy to progression or death, up to 3 years ]

Central Contacts

• Karen Fitzpatrick, RN
  215-439-2294
  [email protected]

Locations (146)

Find similar trials in Birmingham, AL

Related Studies

• Dabrafenib and/or Trametinib Rollover Study
  PHASE4 · Recruiting · Novartis Pharmaceuticals · Scottsdale, Arizona
• SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
  Recruiting · Massive Bio, Inc. · Birmingham, Alabama
• Study of NEO-201 in Solid Tumors Expansion Cohorts
  PHASE1/PHASE2 · Recruiting · Precision Biologics, Inc · Bethesda, Maryland
• Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
  Recruiting · University of Missouri-Columbia · Columbia, Missouri