Metastatic NSCLC Clinical Trial
— HOPE-1Official title:
A Multicenter, Randomized, Open, Parallel Grouping, Investigator-initiated Study Evaluating the Long-term Benefit of Patients With Locally Advanced/Metastatic Non-small Cell Lung Cancer Followed up Using a Patient-wide Management Platform
NCT number | NCT05339568 |
Other study ID # | WYKA001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 22, 2022 |
Est. completion date | August 20, 2030 |
Our project is going to explore whether management and follow-up of locally advanced/metastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.
Status | Recruiting |
Enrollment | 1268 |
Est. completion date | August 20, 2030 |
Est. primary completion date | April 21, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Fully understand the research and voluntarily sign the informed consent form (ICF) 2. Male or female subjects who are over 18 years old (inclusive) at the time of signing the informed consent form. 3. The subject is diagnosed pathologically or cytologically with non-small cell lung cancer(NSCLC). 4. According to the 8th edition of the American Joint Committee on Cancer [AJCC], it is classified as stage IIB, stage III, stage IV NSCLC. 5. Not suitable for radical treatment or refuse surgery. 6. The life expectancy is not less than 3 months. 7. Be able to use a smartphone. Exclusion Criteria: 1. Patients with mental illness. 2. Presence of any other malignant tumor. 3. Patients who are expected to undergo radical surgery. 4. Currently participating in clinical trials. 5. Subjects who judged by the investigator to be unsuitable to participate in the trial. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Qianfoshan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival time | OS was calculated from the date of randomization to death from any cause. | UP to 96 months | |
Secondary | Progression-free survival (PFS) | PFS was calculated from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months. | Up to 96 months | |
Secondary | Adverse events rate | Adverse events were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. | Up to 96 months | |
Secondary | Patients' follow-up compliance | Patients' follow-up compliance were assessed by the N of hospital visits according to the doctors' advice every year. | Up to 96 months | |
Secondary | The quality of life | The quality of life were assessed by SF-36,The SF-36 questionnaire consists of 8 section, including physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health, also including reported health transition. The scoring steps: 1 encode the scale 2 credit the scale 3 score conversion(conversion formula=(actual score-the possible lowest score of this section)/the difference between the possible highest score and the possible lowest score of this section).The higher the score conversion, the better the health. | Up to 96 months | |
Secondary | Follow-up satisfaction | Follow-up satisfaction were assessed by the questionnaire. The questionnaire is including 12 questions, where 28 is the worst imaginable satisfaction state and 130 is the best imaginable satisfaction state. | Up to 96 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05091190 -
Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers
|
N/A | |
Recruiting |
NCT04170634 -
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
|
||
Recruiting |
NCT05255302 -
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04615884 -
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
|
N/A | |
Recruiting |
NCT04846452 -
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
|
Phase 2 | |
Recruiting |
NCT05480865 -
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
|
Phase 1 | |
Terminated |
NCT03417882 -
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
|
Phase 2 | |
Recruiting |
NCT03589339 -
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
|
Phase 1 | |
Suspended |
NCT05617313 -
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT05403385 -
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
|
Phase 2 | |
Recruiting |
NCT06159790 -
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
Phase 3 |