Leptomeningeal MetastasisPhase 2NCT06441045
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
A Phase 2 study testing Double Dose of Third-generation EGFR-TKI and Intrathecal Pemetrexed in people with Leptomeningeal Metastasis, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
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, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- Double Dose of Third-generation EGFR-TKI and Intrathecal Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Normal main organ function, That is, the following criteria are met:
- routine blood examination (no blood transfusion within 14 days, no hematopoietic stimulating factor drugs are corrected state): hemoglobin (Hb) 90g / L; Absolute neutrophil count (ANC) 1.5109 / L; Platelet (PLT) 100109 / L; White blood cell count (WBC) 3.0109 / L;
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- Biochemical examination: alanine transaminotransferase (ALT) and alanine transaminotransferase (AST) 2.5 upper limit of normal (ULN); Serum total bilirubin (TBIL) 1.5 ULN; Serum creatinine (Cr) of 1.5 ULN or creatinine clearance of 50 ml/min; If any liver metastasis, Then, the total bilirubin 3 ULN, ALT and AST 5 ULN; C) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time 12 (PT) 1.5 ULN;
- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) 50%;
- If previously treated with chemotherapy, A washout period of at least 21 days between the last chemotherapy dose and enrollment (if the patient does not receive radiotherapy) is required; Patients who treated brain parenchymal metastases with local radiotherapy or surgery before enrollment, Must be completed and fully recovered from the acute toxicity of radiotherapy / surgery. A minimum 14-day washout period is required between the end of radiotherapy and enrollment. A minimum 30-day washout period is required between the end of surgery and enrollment.
- Expected survival of not less than 3 months
- patients can swallow oral medication (if not oral, can be ground by gastric tube)
- Women of childbearing age must have negative pregnancy test (serum or urine) within 14 days before observation period and 3 months after the last administration; for men, they should undergo surgical sterilization or agree to use appropriate contraception during the observation period and 3 months after the last administration of study drug
- patients voluntarily participate and sign an informed consent (or legal agent), expected to have good compliance and able to cooperate with the study according to the protocol requirements.
Who cannot join
- 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;
- arterial / venous thrombosis events within 6 months prior to enrollment, Such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
- congestive heart failure (NYHA grade> 2); unstable angina pectoris; a myocardial infarction within 3 months prior to signing an ICF; any 12 supraventricular or ventricular arrhythmia requiring treatment or intervention; Mean QTcF> 470ms from 3 ECG recordings
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- other systemic malignancies in the last 5 years, (Except for cured skin basal cell carcinoma and cervical situ carcinoma and ovarian carcinoma);
- Use drugs or supplements known to be the main cause of CYP3A4.
- Persons known to be allergic to any test drug or its excipients;
- pregnant, lactating, reproductive patients unwilling to use effective contraception; ●a clear prior history of neurological or psychiatric disorders, including epilepsy and dementia;
- other conditions considered inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in NSCLC Patients With Leptomeningeal Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI: a Phase II Randomized, Multicenter Study
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,
- Conditions
- Leptomeningeal Metastasis
- Being tested
- Double Dose of Third-generation EGFR-TKI, Intrathecal Pemetrexed
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Dose of Third-generation EGFR-TKIDrug
Double Dose of Third-generation EGFR-TKI
Intrathecal PemetrexedDrug
Intrathecal Pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed | Experimental | Not described Receives: Drug: Double Dose of Third-generation EGFR-TKI; Drug: Intrathecal Pemetrexed |
| Double Dose of Third-generation EGFR-TKI | Active comparator | Not described Receives: Drug: Double Dose of Third-generation EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From date of randomization until the date of death from any cause assessed up to 12 months after the last patient enrollment
Secondary outcomes (5)
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
Measured: 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
LM-PFS
Measured: 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
LM-ORR
Measured: From date of randomization until the date of first documented LM progression assessed up to 12 months after the last patient enrollment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Safety and tolerability
Measured: 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
exLM-PFS
Measured: From date of randomization until the date of first documented non-LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gen Lin, Principal investigator, Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441045
- Sponsor's protocol ID
- SQS2024-175
- Status last verified
- Jun 2024
- First submitted
- 3 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed Versus Double Dose of Third-generation EGFR-TKI in NSCLC Patients With Leptomeningeal Progression Following the Treatment of Routine Dose of Third-generation EGFR-TKI: a Phase II Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT06441045
- Acronym / sponsor ID
- SQS2024-175
- Conditions
- Leptomeningeal Metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed | Experimental | Drug: Double Dose of Third-generation EGFR-TKI, Drug: Intrathecal Pemetrexed |
| Double Dose of Third-generation EGFR-TKI | Active comparator | Drug: Double Dose of Third-generation EGFR-TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Normal main organ function, That is, the following criteria are met:
Key exclusion criteria (11 listed)
- 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;
- arterial / venous thrombosis events within 6 months prior to enrollment, Such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Dose of Third-generation EGFR-TKIDouble Dose of Third-generation EGFR-TKI | Drug | Double Dose of Third-generation EGFR-TKI, Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed |
| Intrathecal PemetrexedIntrathecal Pemetrexed | Drug | Double Dose of Third-generation EGFR-TKI Plus Intrathecal Pemetrexed |
Primary outcome
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
5 secondary outcomes
Quality of life by using QLC 30 questionnaire
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
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
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
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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
exLM-PFS
Time frame: From date of randomization until the date of first documented non-LM progression or date of death from any cause, whichever came first assessed up to 12 months after the last patient enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gen Lin principal investigator
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Double Dose of Third-generation EGFR-TKI and Intrathecal Pemetrexed in people with Leptomeningeal Metastasis, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gen Lin (13313786157, lingen197505@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.