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

Recruiting

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

• Registration Number: NCT06376084
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-19
• Study Start: 2024-07-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-09
• Primary Completion: 2028-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-World Progression Free Survival (rwPFS)	Follow up approximately 36 months after last patient in	rwPFS is defined as the time from the date of first-line initiation until disease progression or death by investigator report as recorded in the CRF

Secondary Outcome Measures

Name	Time	Method
Duration of chemotherapy (induction and maintenance cycles)	Follow up approximately 36 months after last patient in	Duration of first-line Osimertinib plus chemotherapy, and duration of initial therapy prior to first-line Osimertinib plus chemotherapy (i.e., prior Osimertinib only, prior chemotherapy only).
Response rate	Follow up approximately 36 months after last patient in	Response rate (RR) is defined as the percentage of patients with the best response of "responding" by investigator report as recorded in CRF. Patients who discontinue treatment without progression, receive a subsequent therapy, and then respond will not be included as responders in the RR calculation.
Chemotherapy regimen	Follow up approximately 36 months after last patient in	Chemotherapy information i.e. dose, number of induction chemotherapy cycles and duration of chemotherapy maintenance, any dose changes and reasons for these changes and date of last administration will also be recorded.
Duration of response	Follow up approximately 36 months after last patient in	DoR: is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression. The end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. The time of the initial response will be defined as the latest of the dates contributing toward the first visit response. If a patient does not progress following a response, then his/her duration of response will use the PFS censoring time as the end point for their DoR calculation.
Overall survival (OS)	Follow up approximately 36 months after last patient in	OS is defined as the time from the first-line initiation until death due to any cause regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Shanghai, China