UmbREALung - A Retrospective and Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance

Response is assessed via clinical or radiologic judgment or RECIST criteria

rwEFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of progression of the disease (PD) that precluded definitive surgery or discovered while attempting surgery, local or distant recurrence, or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have event on the date of death. For patients who remain alive and who had no event, EFS will be censored on the date of last evaluable disease assessment.

rwDFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first investigator-determined recurrence (local or distant) or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have recurred on the date of death. For patients who remain alive and whose disease has not recurred, DFS will be censored on the date of last evaluable disease assessment

rwPFS defined as time from index date to progression (PD) or death due to any cause.

Early progressors (within 6 months) based on progression-free or recurrence-free survival

rwPFS2 defined as time from index date to the earliest progression event subsequent to that used for the PFS endpoint or death due to any cause. Endpoints will be median time to second real-world progression (mrwPFS2) and rates

Real-word distant progression-free (rwD-PFS) or distant recurrence-free survival (rwD-RFS), defined as the time from index date to an event of distant progression or distant recurrence or death due to any cause, whichever occurred first. Endpoints will be median time to second real world to the event and rates

Real-word locoregional recurrence-free survival (rwL-RFS), defined as the time from index date to an event of local progression or local recurrence or death due to any cause, whichever occurred first. Endpoints will be median time to event and rates

rw OS is defined as the time from the index date to death due to any cause, Real world median Endpoints will be median time to the event and rates

rwTTD is defined as the time from the index date (date of first administration of module-specific AZ-approved drug) to the date of last administration (+duration of the drug cycle, when applicable) or date of death (due to any cause). A patient who dies without reported treatment discontinuation will be considered to have discontinued on the date of death. For patients still receiving the selected drug at the end of follow-up, TTD will be censored on the last recorded day of ongoing treatment.

Real world time to next treatment (rwTTNT) as defined the period from the start of the treatment to the start of the next line of treatment. In the resectable cohort, local treatment will be considered as new treatment (surgery, radiotherapy) as occurring after a confirmation of progression. Endpoints will be median time to event and rates

Real world time to first subsequent local treatment (rwTFST-local treatment) as defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first subsequent local therapy (including supportive or curative RT or surgery) or the date of death (due to any cause)

rwTFST is defined as the time from the index date (date of first administration of module-specific AZ-approved drug) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific approved drugs developed by AZ or as part of an AZ alliance at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment

Associated therapies will comprise curative therapies for NSCLC, including surgery, radiotherapy (RT), associated chemotherapy and radiotherapy (CRT), as used to treat different stages of the disease in addition to the approved drugs developed by AZ or as part of an AZ alliance subject of the specific module. Outcomes related to this objective are specific to each stage of the disease and thus to each cohort. For resectable and unresectable NSCLC (cohort A and B), the treatment of the primitive tumor will include neoadjuvant treatment, curative treatment (surgery for cohort A and CRT for cohort B) and post-curative adjuvant or consolidation treatment.

For mNSCLC (cohort C), the treatment will describe the line of systemic treatment received (including CT) and the supportive RT or surgery when applicable.