Lung Cancer (NSCLC)Phase 1NCT06663306
Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC
A Phase 1 study testing Pemetrexed and Bevacizumab in people with Lung Cancer (NSCLC) and Leptomeningeal Metastasis, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC), Leptomeningeal Metastasis
- What is being tested?
- Pemetrexed and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2024to 30 Dec 2027
- Phase
- Phase 1
- 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;
- ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
- Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
- Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;
- Expected survival time ≥ 1 month;
- The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min;
- Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study;
- Understand and sign the informed consent form.
Who cannot join
- Positive for human immunodeficiency virus (HIV) ;
- History of allergy to pemetrexed or bevacizumab;
- History of pemetrexed and/or bevacizumab intrathecal Injection;
- Presence of contraindication of bevacizumab:
- Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
- Urine protein≥2+,or 24-hour urine protein≥2g；
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- Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia;
- Major hemoptysis within the past 1 month; History of coagulation disorders;
- Presence of serious non-healing wounds, ulcers, or bone fractures
- Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction;
- Presence of macrovascular invasion；
- Some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis;
- Brain/spinal cord radiation therapy within 1 week before enrollment;
- Pregnant and lactating female;
- Refuse to use contraception during the study period;
- Individuals considered by the investigator to be unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Hua Zhong, MD, +86 021-22200000, eddiedong8@hotmail.com
About this study
Official title: Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
- Conditions
- Lung Cancer (NSCLC), Leptomeningeal Metastasis
- Being tested
- Pemetrexed, Bevacizumab
- Keywords
- Leptomeningeal Metastases, NSCLC, Intrathecal Injection
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks
BevacizumabDrug
Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Enrolled patients were treated with pemetrexed intrathecal injection Receives: Drug: Pemetrexed |
| Arm B | Experimental | Enrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection Receives: Drug: Pemetrexed; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Safety and Tolerability)
Number of participants with adverse events, treatment emergent adverse events,and serious adverse events assessed by CTCAE v5.0 as a measure of safety and tolerability.
Measured: From the beginning of the treatment until two months after the treatment.
Secondary outcomes (1)
Overall Survival (OS)
Kaplan-Meier method used to estimate the distribution of OS from the start of study treatment.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start9 Dec 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Shanghai Chest 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Principal investigator, Hua Zhong, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663306
- Sponsor's protocol ID
- IS24103
- Status last verified
- Feb 2026
- First submitted
- 24 Oct 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in this study will be made available upon reasonable request from the corresponding author, subject to institutional review and applicable regulations.
Publications
Kuang Y, Teng J, Wang W, Zhang B, Cheng L, Zhang Y, Liu W, Gao Z, Nie W, Xiong L, Shi C, Zhang W, Lou Y, Han B, Zhong H. Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial. BMJ Open. 2026 Mar 23;16(3):e116187. doi: 10.1136/bmjopen-2026-116187.
PubMed 41877338
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
- ClinicalTrials.gov ID
- NCT06663306
- Acronym / sponsor ID
- IS24103
- Conditions
- Lung Cancer (NSCLC), Leptomeningeal Metastasis
- Keywords
- Leptomeningeal Metastases, NSCLC, Intrathecal Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Oct 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.
This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PemetrexedEnrolled patients were treated with pemetrexed intrathecal injection |
| Arm B | Experimental | Drug: Pemetrexed, Drug: BevacizumabEnrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
- Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
- Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;
- Expected survival time ≥ 1 month;
Key exclusion criteria (16 listed)
- Positive for human immunodeficiency virus (HIV) ;
- History of allergy to pemetrexed or bevacizumab;
- History of pemetrexed and/or bevacizumab intrathecal Injection;
- Presence of contraindication of bevacizumab:
- Brain/spinal cord radiation therapy within 1 week before enrollment;
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 |
|---|---|---|
| PemetrexedIntrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks | Drug | Arm A, Arm B |
| BevacizumabIntrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg. | Drug | Arm B |
Primary outcome
Incidence of Adverse Events (Safety and Tolerability)
Time frame: From the beginning of the treatment until two months after the treatment.
Number of participants with adverse events, treatment emergent adverse events,and serious adverse events assessed by CTCAE v5.0 as a measure of safety and tolerability.
1 secondary outcome
Overall Survival (OS)
Time frame: Up to 2 years
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 2 Mar 2026.
- Derived from this study: PubMed 41877338Kuang Y, Teng J, Wang W, Zhang B, Cheng L, Zhang Y, Liu W, Gao Z, Nie W, Xiong L, Shi C, Zhang W, Lou Y, Han B, Zhong H. Safety and efficacy of intrathecal pemetrexed and bevacizumab in non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM): protocol for a single-arm, prospective, phase Ia trial. BMJ Open. 2026 Mar 23;16(3):e116187. doi: 10.1136/bmjopen-2026-116187.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in this study will be made available upon reasonable request from the corresponding author, subject to institutional review and applicable regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemetrexed and Bevacizumab in people with Lung Cancer (NSCLC) and Leptomeningeal Metastasis, run by Shanghai Chest 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 8 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Hua Zhong, MD (+86 021-22200000, eddiedong8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (Safety and Tolerability) (time frame: From the beginning of the treatment until two months after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663306, which also lists 1 linked publication.
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 2 Mar 2026.