Condition or disease |
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Carcinoma, Non-Small-Cell Lung |
Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.
Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 527 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC. |
Actual Study Start Date : | July 25, 2019 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Pneumonitis and AESIs will be summarized at least following categories
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Research Site | |
Nagoya, Aichi, Japan | |
Research Site | |
Toyoake, Aichi, Japan | |
Research Site | |
Matsuyama, Ehime, Japan | |
Research Site | |
Kurume, Fukuoka, Japan | |
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Maebashi, Gunma, Japan | |
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Asahikawa, Hokkaido, Japan | |
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Sapporo, Hokkaido, Japan | |
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Akashi, Hyogo, Japan | |
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Kobe, Hyogo, Japan | |
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Kasama, Ibaraki, Japan | |
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Kanazawa, Ishikawa, Japan | |
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Morioka, Iwate, Japan | |
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Sagamihara, Kanagawa, Japan | |
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Yokohama, Kanagawa, Japan | |
Research Site | |
Matsubara, Mie, Japan | |
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Natori, Miyagi, Japan | |
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Sendai, Miyagi, Japan | |
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Nishihara, Okinawa, Japan | |
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Hirakata, Osaka, Japan | |
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Osakasayama, Osaka, Japan | |
Research Site | |
Sakai, Osaka, Japan | |
Research Site | |
Hidaka, Saitama, Japan | |
Research Site | |
Izumo, Shimane, Japan | |
Research Site | |
Mishima, Shizuoka, Japan | |
Research Site | |
Mibu, Tochigi, Japan | |
Research Site | |
Shimotsuke, Tochigi, Japan | |
Research Site | |
Bunkyo, Tokyo, Japan | |
Research Site | |
Chuo, Tokyo, Japan | |
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Koto, Tokyo, Japan | |
Research Site | |
Mitaka, Tokyo, Japan | |
Research Site | |
Shinjuku, Tokyo, Japan | |
Research Site | |
Iwakuni, Yamaguchi, Japan | |
Research Site | |
Chiba, Japan | |
Research Site | |
Fukuoka, Japan | |
Research Site | |
Hiroshima, Japan | |
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Kyoto, Japan | |
Research Site | |
Nagasaki, Japan | |
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Niigata, Japan | |
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Okayama, Japan | |
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Osaka, Japan | |
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Saitama, Japan | |
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Tokushima, Japan | |
Research Site | |
Wakayama, Japan |
Tracking Information | |||
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First Submitted Date | June 6, 2019 | ||
First Posted Date | June 24, 2019 | ||
Last Update Posted Date | April 12, 2021 | ||
Actual Study Start Date | July 25, 2019 | ||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||
Change History | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC | ||
Official Title | Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC. | ||
Brief Summary | This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world. | ||
Detailed Description |
Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent. Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test |
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Study Type | Observational [Patient Registry] | ||
Study Design | Observational Model: Other Time Perspective: Prospective |
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Target Follow-Up Duration | 3 Years | ||
Biospecimen | Not Provided | ||
Sampling Method | Non-Probability Sample | ||
Study Population | Total 500 patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy will be enrolled. The patients should be registered consecutively in each site. | ||
Condition | Carcinoma, Non-Small-Cell Lung | ||
Intervention | Not Provided | ||
Study Groups/Cohorts | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Active, not recruiting | ||
Actual Enrollment |
527 | ||
Original Estimated Enrollment |
500 | ||
Estimated Study Completion Date | December 31, 2023 | ||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Japan | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT03995875 | ||
Other Study ID Numbers | D4194R00013 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||
Responsible Party | AstraZeneca | ||
Study Sponsor | AstraZeneca | ||
Collaborators | Japan Lung Cancer Society | ||
Investigators | Not Provided | ||
PRS Account | AstraZeneca | ||
Verification Date | April 2021 |