Combining Osimertinib with chemotherapy for advanced lung cancer
Osimertinib With Chemotherapy as First-line Therapy for Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-Small Cell Lung Cancer (NSCLC): A Multicentre, Observational Study (FOREFRONT)
This study is trying out a combination of Osimertinib and chemotherapy to see if it helps people with advanced lung cancer live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Osimertinib, chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06376084 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and safety of Osimertinib in combination with chemotherapy for patients with locally advanced or metastatic, EGFR mutation-positive non-small cell lung cancer (NSCLC). It focuses on real-world clinical outcomes, including progression-free survival (PFS) and overall survival (OS), as reported by investigators. Eligible patients are those who have not undergone curative surgery or definitive chemoradiation and are receiving this combination as their first-line treatment. The study will gather data to better understand the treatment's impact in a practical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced, EGFR mutation-positive NSCLC who are not suitable for curative surgery.
Not a fit: Patients with early-stage NSCLC or those who have already received extensive prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced EGFR mutation-positive NSCLC.
How similar studies have performed: Previous studies have shown promising results with similar combinations of targeted therapies and chemotherapy in treating NSCLC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Histologically or cytologically documented nonsquamous NSCLC. NSCLC of mixed histology is allowed. * Stage IIIB or IIIC or Stage IV metastatic NSCLC or recurrent NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative surgery or definitive chemoradiation. * EGFR sensitive mutation-positive (Ex19del and/or 21 L858R) * WHO performance status of 0 to 2 at screening with no clinically significant deterioration in the previous 2 weeks. * Patients who receive Osimertinib plus chemotherapy as first-line treatment based on physician's medical assessment are eligible (For patients who received prior chemotherapy alone/Osimertinib monotherapy/Osimertinib plus chemotherapy as first-line therapy ahead of enrolment, they are diseases progression-free at the time of enrolment and the duration of prior therapy ≤3 months). * Patients with asymptomatic CNS metastases or patients who have completed definitive therapy, are not on steroids and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids are allowed. * Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapies, investigational agents are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. Exclusion Criteria: * Spinal cord compression and symptomatic brain metastases * Past medical history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD * Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, etc * Any banned substance in label
Where this trial is running
Shanghai
- Research Site — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Baohui HAN — Shanghai Chest Hospital
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.