Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
NCT ID: NCT04322890
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
6000 participants
INTERVENTIONAL
2020-04-16
2027-12-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: EGFR mutation
Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.
Osimertinib
Osimertinib 80mg, po, qd;
Cohort B: ALK fusion
Lung Cancer with ALK fusion.
Alectinib 150 MG
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Cohort C: ROS1 fusion
Lung Cancer with ROS1 fusion.
Crizotinib 250 MG
Crizotinib 250 MG po bid.
Cohort D: MET alterations
Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.
Savolitinib, Crizotinib.
Savolitinib, 300mg po qd.
Cohort E: RET fusion
Lung Cancer with RET fusion.
Chemotherapy
500mg, ivgtt, every 21day.
Cohort F: KRAS mutation
Lung Cancer with KRAS mutation.
Chemotherapy
500mg, ivgtt, every 21day.
Cohort G: uncommon mutation
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.
Chemotherapy
500mg, ivgtt, every 21day.
Interventions
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Osimertinib
Osimertinib 80mg, po, qd;
Alectinib 150 MG
Alectinib 600mg, po, qd; Lorlatinib, 100mg, po, qd;
Crizotinib 250 MG
Crizotinib 250 MG po bid.
Savolitinib, Crizotinib.
Savolitinib, 300mg po qd.
Chemotherapy
500mg, ivgtt, every 21day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Hunan Province Tumor Hospital
OTHER
Responsible Party
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Yongchang Zhang
Professor, Director of Clinical Trial Center
Principal Investigators
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Yongchang Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Hunan Cancer Hospital
Locations
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Yongchang Zhang
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20200311
Identifier Type: -
Identifier Source: org_study_id
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