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To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS .
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy regimen | 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. | Follow up approximately 36 months after last patient in |
| Duration of chemotherapy (induction and maintenance cycles) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Baohui HAN | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40978050 | Derived | 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. |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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.
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.
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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). |
| Follow up approximately 36 months after last patient in |
| Response rate | 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. | Follow up approximately 36 months after last patient in |
| Duration of response | 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. | Follow up approximately 36 months after last patient in |
| Overall survival (OS) | 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. | Follow up approximately 36 months after last patient in |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
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