Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

Sponsor
Hunan Province Tumor Hospital
Study ID
NCT04322890
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 80mg, po, qd;
  • 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.

Study Details

The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Key Dates

Start date
Apr 16, 2020
Status verified
Oct 2024
Primary completion
Dec 24, 2026
Completion
Dec 24, 2027

Study Design

Enrollment
6,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: EGFR mutation
    Lung Cancer with EGFR mutation including EGFR exon19del, exon 21L858R, etc.
  • Experimental: Cohort B: ALK fusion
    Lung Cancer with ALK fusion.
  • Experimental: Cohort C: ROS1 fusion
    Lung Cancer with ROS1 fusion.
  • Experimental: Cohort D: MET alterations
    Lung Cancer with MET alteration including amplification, exon 14 skipping and met fusion etc.
  • Experimental: Cohort E: RET fusion
    Lung Cancer with RET fusion.
  • Experimental: Cohort F: KRAS mutation
    Lung Cancer with KRAS mutation.
  • Experimental: 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.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Time from first subject dose to study completion, or up to 36 month ]

Central Contacts

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