Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osimertinib, Alectinib 150 MG, Crizotinib 250 MG, Savolitinib, Crizotinib..
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROS1 Gene Mutation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Overview
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Detailed description
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.
Interventions
- Drug Osimertinib
Osimertinib 80mg, po, qd; - Drug Alectinib 150 MG
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd; - Drug Crizotinib 250 MG
Crizotinib 250 MG po bid. - Drug Savolitinib, Crizotinib.
Savolitinib, 300mg po qd. - Drug Chemotherapy
500mg, ivgtt, every 21day.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Time from first subject dose to study completion, or up to 36 month]
Secondary outcome measures (4)
- Overall survival (OS) [Time frame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years]
- Objective Response Rate (ORR) [Time frame: Time from first subject dose to study completion, or up to 36 month]
- Adverse events (AEs) according to CTCAE 5.0 [Time frame: From first dose until 28 days after the last dose, up to 24 month]
- Patient reported outcome (PRO) [Time frame: To assess overall survival, define as first dose to the death of the subject due to any cause up to 5 years]
Eligibility criteria
Inclusion criteria
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed, Stage IV NSCLC.
- Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
- ECOG 0-1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
Exclusion criteria
The patient did not match from the Inclusion Criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Yongchang Zhang — Changsha
Identifiers
NCT: NCT04322890 · 20200311