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Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in Patients With LM Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI

ConditionLeptomeningeal Metastasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Cancer Hospital

About this trial

We aim to compare the efficacy and safety of double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus double Dose of Third-generation EGFR-TKI in patients with leptomeningeal progression following the treatment of routine dose of EGFR-TKI,

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years at the time of signing informed consent, both sexes;

advanced or metastatic NSCLC, TNM stage IV according to the eighth edition of IASLC 2015;

with EGFR sensitive mutation (exon 19 deletion or L858R mutation), LM progression after conventional doses of three generation EGFR targeted agents (after 1 + 3,2 + 3 or direct 3-generation targeted therapy). There is no limit on the number of chemotherapy lines. The enrolled patients required brain parenchyma and extracranial lesion stable

ECOG PS score: 0-3

Disqualifiers

Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the study program;

Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS)

patient with active bacterial infection, fungal infection (intravenous antibiotics required at initiation of study treatment);

past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid therapy, Or any signs of clinically active interstitial lung disease;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Double Dose of Third-generation EGFR-TKI

    Drug

    Double Dose of Third-generation EGFR-TKI

  • Intrathecal Pemetrexed

    Drug

    Intrathecal Pemetrexed

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Double Dose of Third-generation EGFR-TKI Plus Intrathecal PemetrexedExperimental treatment 2 interventions
Group B: Double Dose of Third-generation EGFR-TKIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

Time frame
From date of randomization until the date of death from any cause assessed up to 12 months after the last patient enrollment

Secondary outcomes

1

Quality of life by using QLC 30 questionnaire

By using QLC 30 questionnaire to investigate the impact of treatment on patients' QoL specifically the physical and neurological function in patients

Time frame
every 4 weeks, from date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment
2

LM-PFS

Time frame
From date of randomization until the date of first documented LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment
3

LM-ORR

Time frame
From date of randomization until the date of first documented LM progression assessed up to 12 months after the last patient enrollment
4

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Safety and tolerability

Time frame
From date of randomization until the date of first documented LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment

Other outcomes

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: