Non Small Cell Lung Cancer Clinical Trial
— PIKACHUOfficial title:
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Status | Recruiting |
Enrollment | 6000 |
Est. completion date | December 24, 2027 |
Est. primary completion date | December 24, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age = 18 years. 3. Histologically or cytologically confirmed, Stage IV NSCLC. 4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc. 5. ECOG 0-1. 6. Predicted survival = 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. Exclusion Criteria: The patient did not match from the Inclusion Criteria. |
Country | Name | City | State |
---|---|---|---|
China | Yongchang Zhang | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Hunan Province Tumor Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause. | Time from first subject dose to study completion, or up to 36 month | |
Secondary | Overall survival (OS) | To assess overall survival, define as first dose to the death of the subject due to any cause | To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years | |
Secondary | Objective Response Rate (ORR) | To assess progression-free survival of patients treated with target treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause. | Time from first subject dose to study completion, or up to 36 month | |
Secondary | Adverse events (AEs) according to CTCAE 5.0 | Number of participants with adverse events (AEs) according to CTCAE 5.0 | From first dose until 28 days after the last dose, up to 24 month | |
Secondary | Patient reported outcome (PRO) | Patient reported outcome defined as the quality of life during the whole process treatment. | To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years |
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