Carcinoma, Non-Small-Cell Lung Clinical Trial
— iDETECTOfficial title:
A Non Interventional Pilot Study on Machine Learning for ILD Detection Based on the Patient Data From Digital Devices in Unresectable Stage III Non-Small Cell Lung Cancer Patients Receiving Durvalumab
NCT number | NCT04884269 |
Other study ID # | D4194R00024 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 11, 2021 |
Est. completion date | March 3, 2023 |
Verified date | February 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objective in this study is to investigate feasibility of developing machine-learning based model for the identification of future development of diagnosed Grade 2 and higher ILD and of disease progression in patients with unresectable Stage III NSCLC receiving durvalumab
Status | Completed |
Enrollment | 144 |
Est. completion date | March 3, 2023 |
Est. primary completion date | March 3, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Patient who provided written signed informed consent prior to the first study-specific procedures. - Patient who receives durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy - Patient whose performance status showed 0 or 1 prior to durvalumab treatment - Patient who is able and willing to wear the devices daily for up to 6 months as instructed Exclusion Criteria: - Patient under immunotherapy treatment other than durvalumab. - Patient had received prior immunotherapy - Patient under the interventional clinical studies using unapproved drugs or off-label use of drugs - Patient who showed ILD (including radiation pneumonitis) of Grade 2 and higher, after consolidated chemoradiation therapy. - Patient who is judged as not suitable for the study by the study site investigators, in terms of fitting wearable devices, presence of silicone or metallic allergy |
Country | Name | City | State |
---|---|---|---|
Japan | Research Site | Bunkyo | Tokyo |
Japan | Research Site | Bunkyo | Tokyo |
Japan | Research Site | Fukuoka | |
Japan | Research Site | Hidaka | Saitama |
Japan | Research Site | Hirakata | Osaka |
Japan | Research Site | Kitaadachi-gun Ina | Saitama |
Japan | Research Site | Kurashiki | Okayama |
Japan | Research Site | Matsusaka | Mie |
Japan | Research Site | Matsuyama | Ehime |
Japan | Research Site | Mitaka | Tokyo |
Japan | Research Site | Nagoya | Aichi |
Japan | Research Site | Nagoya | Aichi |
Japan | Research Site | Natori | Miyagi |
Japan | Research Site | Niigata | |
Japan | Research Site | Okayama | |
Japan | Research Site | Osaka | |
Japan | Research Site | Ota | Gunma |
Japan | Research Site | Sakai | Osaka |
Japan | Research Site | Sapporo | Hokkaido |
Japan | Research Site | Sendai | Miyagi |
Japan | Research Site | Sunto-gun Nagaizumi | Shizuoka |
Japan | Research Site | Tokushima | |
Japan | Research Site | Toyoake | Aichi |
Japan | Research Site | Wakayama | |
Japan | Research Site | Yokohama | Kanagawa |
Japan | Research Site | Yokohama | Kanagawa |
Japan | Research Site | Yokohama | Kanagawa |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Grade 2 and higher ILD including radiation pneumonitis | 6 months | ||
Secondary | Disease progression | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
Completed |
NCT04426825 -
A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer
|
Phase 2 | |
Terminated |
NCT03166631 -
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
|
Phase 1 | |
Completed |
NCT02864394 -
Study of Pembrolizumab Versus Docetaxel in Participants Previously Treated for Non-Small Cell Lung Cancer (MK-3475-033/KEYNOTE-033)
|
Phase 3 | |
Completed |
NCT02810457 -
Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer
|
Phase 3 | |
Recruiting |
NCT04592523 -
A Study of Usage of Brigatinib in the Treatment of Adult Participants for Approved Indications In South Korea
|
||
Recruiting |
NCT04838548 -
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT04077463 -
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT04603807 -
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
|
Phase 3 | |
Recruiting |
NCT05167604 -
Clinical Value of MRD Monitoring for Adjuvant Therapy in Postoperative NSCLC
|
||
Completed |
NCT04948411 -
Durvalumab as Maintenance in Patients Who Received Chemoradiotherapy for Unresectable Stage III NSCLC: Real World Data From an Expanded Access Program in Brazil
|
||
Active, not recruiting |
NCT04487080 -
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Not yet recruiting |
NCT04255836 -
Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
Completed |
NCT01953913 -
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
|
Phase 3 | |
Recruiting |
NCT05715229 -
Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy
|
Phase 2 | |
Recruiting |
NCT04931654 -
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer
|
Phase 1/Phase 2 | |
Suspended |
NCT05421936 -
Osimertinib for NSCLC With Uncommon EGFR Mutations
|
||
Completed |
NCT02847377 -
A Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
|
N/A | |
Completed |
NCT04427072 -
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation
|
Phase 3 | |
Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A |