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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: EGFR mutation | Experimental | Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc. |
|
| Cohort B: ALK fusion | Experimental | Lung Cancer with ALK fusion. |
|
| Cohort C: ROS1 fusion | Experimental | Lung Cancer with ROS1 fusion. |
|
| Cohort D: MET alterations | Experimental | Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc. |
|
| Cohort E: RET fusion | Experimental | Lung Cancer with RET fusion. |
|
| Cohort F: KRAS mutation | Experimental | Lung Cancer with KRAS mutation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osimertinib | Drug | Osimertinib 80mg, po, qd; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
The patient did not match from the Inclusion Criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong Yang, MD | Contact | +8613055193557 | +8613873123436 | yangnong0217@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongchang Zhang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongchang Zhang | Recruiting | Changsha | Hunan | 410013 | China |
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|
| Cohort G: uncommon mutation | Experimental | 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. |
|
| Alectinib 150 MG | Drug | Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd; |
|
|
| Crizotinib 250 MG | Drug | Crizotinib 250 MG po bid. |
|
|
| Savolitinib, Crizotinib. | Drug | Savolitinib, 300mg po qd. |
|
|
| Chemotherapy | Drug | 500mg, ivgtt, every 21day. |
|
|
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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| C000705711 | aflutinib |
| C582670 | alectinib |
| C000590786 | lorlatinib |
| C000598580 | brigatinib |
| D000077547 | Crizotinib |
| C000607349 | entrectinib |
| C000593259 | 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine |
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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