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
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.
- 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