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

ConditionsNon Small Cell Lung CancerEGFR Gene MutationALK Gene MutationROS1 Gene MutationMET Gene Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

6,000 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Cohort A: EGFR mutationExperimental treatment 1 intervention
Group B: Cohort B: ALK fusionExperimental treatment 1 intervention
Group C: Cohort C: ROS1 fusionExperimental treatment 1 intervention
Group D: Cohort D: MET alterationsExperimental treatment 1 intervention
Group E: Cohort E: RET fusionExperimental treatment 1 intervention
Group F: Cohort F: KRAS mutationExperimental treatment 1 intervention
Group G: Cohort G: uncommon mutationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Province Tumor Hospital

Lead sponsor

Source ClinicalTrials.gov
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