Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC (FOREFRONT)

AstraZeneca

Status: Active, not recruiting

Conditions: Lung Neoplasms; Carcinoma, Bronchogenic; Thoracic Neoplasms; Lung Diseases; Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms; Respiratory Tract Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT06376084

D5161R00055

Details and patient eligibility

About

To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .

Full description

The objectives of this study are to assess the effectiveness and safety of Osimertinib combined with chemotherapy in a real-world setting in patients with locally advanced or metastatic, EGFR mutation-positive NSCLC.

Enrollment: 532 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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