First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy
- Conditions
- NSCLC
- Registration Number
- NCT03798535
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a non-interventional/observational cohort of unresectable Stage III NSCLC patients treated with durvalumab.
The study will be carried out as a retrospective review of established medical records of unresectable Stage III NSCLC patients treated with durvalumab.
- Detailed Description
This is a non-interventional/observational study including unresectable Stage III NSCLC patients treated with durvalumab. Patients will be selected from the following participating countries: Australia, Belgium, Israel, Netherlands, Norway, France, Germany, Italy, Switzerland, Spain\* and the United Kingdom.
Chart abstractions will occur at specified intervals up to five years after the patient had the first dose of durvalumab. A target of four (maximum five) chart extractions is anticipated for each participant. Dates may be adjusted based on local market ethics processes or patient enrolment.
* First chart extraction will be used to determine which patients meet the inclusion/exclusion criteria for the study and will retrospectively collect all data from diagnosis of unresectable Stage III NSCLC to durvalumab start date (index date).
* The second chart extraction will be triggered at time of estimated maturity of PFS data.
* The third chart extraction will be triggered at time of estimated maturity of OS data.
* The fourth (final) chart extractions will occur 5-years after EAP enrolment to provide final PFS and OS data, together with updated results for all secondary and descriptive endpoints.
* The dates for the second through fourth chart abstractions may be adjusted, pending data availability. The estimated PFS and OS maturity will be calculated from the actual patient index dates (date of first dose of durvalumab) together with the distribution of PFS and OS observed in the PACIFIC trial.
* Spain only contributed to DE1 and DE2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1156
- Written informed consent or any locally required authorisation obtained from the patient prior to performing any protocol-related procedures
- Age ≥ 18 years at time of study entry or adult according to each country regulations for age of majority
- Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8)
- Patients must have been enrolled in one of the durvalumab EAPs Patients must have been treated with at least one dose of durvalumab within the EAP prior to the study entry and between start of EAP in the country, from September 2017 or later up to end of EAP enrolment or MA + three months (estimated as maximum to 30 December 2018) (whichever occurs earlier).
Patients who die during the EAP are eligible to enter in the study when local laws allow for a consent waiver, if all other inclusion/exclusion criteria are met.
-Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world progression free survival (rwPFS) Patients are followed up from the index date (durvalumab (D) first dose date) to progressive disease (PD), death (if no PD), or loss to follow up if no PD/death. PFS reported at 1, 2, 3, and 5 years after D initiation. PFS defined as time from the index date (D first dose date) to the date of investigator-determined disease progression or death (if no progression).
Overall survival (OS) Patients are followed up from the index date (D first dose date) to death or loss to follow up in the absence of death. OS reported at 2, 3, and 5 years after D initiation. OS defined as time from the index date (D first dose date) to the date of death.
- Secondary Outcome Measures
Name Time Method Adverse events of special interest Adverse event data are collected from the time of starting durvalumab (D) throughout the D treatment period up to 90 days after last D infusion or at time of next subsequent therapy initiation (whichever occurred earlier). Adverse events of special interest assessed in the study included the following:
* Diarrhoea / colitis and intestinal perforation
* Pneumonitis / ILD
* Hepatitis / transaminase increases
* Endocrinopathies (i.e., events of hypophysitis / hypopituitarism, adrenal insufficiency, hyper- and hypo-thyroidism and type I diabetes mellitus)
* Rash / dermatitis
* Nephritis / blood creatinine increases
* Pancreatitis / serum lipase and amylase increases
* Myocarditis
* Myositis / polymyositis
* Neuropathy / neuromuscular toxicity (Guillain-Barré, and myasthenia gravis)
* Other inflammatory responses that are rare / less frequent with a potential immune-mediated aetiology include, but are not limited to, pericarditis, sarcoidosis, uveitis, and other events involving the eye, skin, haematological and rheumatological events.Time to death or distant metastasis Patients are followed up from the index date (D first dose date) to distant metastasis (DM), death (if no DM), or loss to follow up if no DM/death. Time to death or DM reported at 1, 2, 3, and 5 years after the D initiation. Time to death or DM was defined as time from the index date (D first dose date) to DM or death (if no DM).
Time to death or local recurrence Patients are followed up from the index date (D first dose date) to local recurrence (LR), death (if no LR), or loss to follow up if no LR/death. Time to death or LR reported at 1, 2, 3, and 5 years after the D initiation. Time to death or LR is defined as time from the index date (D first dose date) to LR or death (if no LR).
Time to first subsequent treatment or death Patients are followed up from the index date (D first dose date) to first subsequent treatment (ST) after D, death (if no ST), or loss to follow up if no ST/death. Time to first ST/death reported at 1, 2, 3, and 5 years after the D initiation. Time to first ST or death is defined as time from the index date (D first dose date) to the first ST or death (if no ST).
Trial Locations
- Locations (1)
Research Site
🇬🇧Stoke on Trent, United Kingdom
Research Site🇬🇧Stoke on Trent, United Kingdom