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

NCT06376084 | Active Not Recruiting

• 1 other identifier: D5161R00055
• Study Type: observational
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Osimertinib; Epidermal Growth Factor Receptor; NSCLC; Non-small cell lung cancer; Observational

Outcome Measures

Primary Outcomes (1)

• Real-World Progression Free Survival (rwPFS)

  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

  Follow up approximately 36 months after last patient in

Secondary Outcomes (5)

• Chemotherapy regimen

  Follow up approximately 36 months after last patient in

• Duration of chemotherapy (induction and maintenance cycles)

  Follow up approximately 36 months after last patient in

• Response rate

  Follow up approximately 36 months after last patient in

• Duration of response

  Follow up approximately 36 months after last patient in

• Overall survival (OS)

  Follow up approximately 36 months after last patient in

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with locally advanced or metastatic, EGFR mutation-positive (Ex19del and/or 21 L858R) NSCLC who receive Osimertinib plus chemotherapy as the first-line therapy based on physician's medical assessment will be enrolled. Approximately 700 patients will be enrolled from about 60 sites in China.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Shanghai, China

Location

Related Publications (1)

• Zhang B, Ning F, Liu X, Li N, Wang P, Yao W, Han B, Wang Q, Zhong H. First-line therapy of osimertinib with chemotherapy in Chinese patients with EGFR mutation-positive non-small cell lung cancer: protocol for a multicenter, prospective, observational study. Front Oncol. 2025 Sep 5;15:1625714. doi: 10.3389/fonc.2025.1625714. eCollection 2025.

  PMID: 40978050 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Bronchial Diseases

Study Officials

• Baohui HAN

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (1)