A Phase 2 interventional study of Osimertinib and Alectinib 150 MG in Non Small Cell Lung Cancer, EGFR Gene Mutation and ALK Gene Mutation, sponsored by Hunan Province Tumor Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Hunan Province Tumor Hospital · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the 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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 6,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hunan Province Tumor Hospital is the lead sponsor of 72 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patient did not match from the Inclusion Criteria.
Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.
Drug: Osimertinib
Lung Cancer with ALK fusion.
Drug: Alectinib 150 MG
Lung Cancer with ROS1 fusion.
Drug: Crizotinib 250 MG
Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.
Drug: Savolitinib, Crizotinib.
Lung Cancer with RET fusion.
Drug: Chemotherapy
Lung Cancer with KRAS mutation.
Drug: Chemotherapy
Cohort G mainly includes all identified lung cancer mutations except EGFR mut, ALK fusion, ROS1 fusion, MET alterations, KRAS mut and RET fusion. These include: BRAF V600E and non-V600E, NRG fusion, NTRK fusion, ERBB2 amp and mut，NRAS mut, MAP2K1 mut，RIT1 mut, RAF1 mut, FGFR fusion, ARAF mut, HRAS mut etc.
Drug: Chemotherapy
Osimertinib 80mg, po, qd;
Also known as: Erlotinib, Gefitinib, Furmonertinib, Almonertinib etc.
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Also known as: Lorlatinib, Alectinib, Brigatinib, Ceritinib etc.
Crizotinib 250 MG po bid.
Also known as: Entrectinib
Savolitinib, 300mg po qd.
Also known as: Crizotinib
500mg, ivgtt, every 21day.
Also known as: Pemetrexed, Cisplatin, Pralsetinib etc.
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 frame: Time from first subject dose to study completion, or up to 36 month
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
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)
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 frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Number of participants with 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)
Patient reported outcome defined as the quality of life during the whole process treatment.
Time frame: 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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Hunan Province Tumor Hospital