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NSCLCPhase 2NCT06332300

An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC

A Phase 2 study testing Adebelimumab+Famitinib + FOLFIRI+Ariely in people with NSCLC, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
Adebelimumab+Famitinib + FOLFIRI+Ariely
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
1 Feb 2024to 1 Feb 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form (ICF)
  • Aged 18-75 years old, male or female.
  • Histologically or cytologically confirmed EGFR mutation-positive non-squamous NSCLC (International Association for the Study of Lung Cancer (IASLC) 8th edition TNM staging criteria)
  • LM diagnosis confirmed by positive CSF cytology
  • Re-biopsy (histology or cytology or hematology) after treatment failure with at least one EGFR tyrosine kinase inhibitor (EGFR-TKI) suggesting no EGFR-sensitive mutation and possibly other treatments
  • All patients are required to have NSCLC associated with at least 1 LM site identified by the investigator that can be evaluated by MRI scanning and is amenable to repeat evaluation.
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  • not required to have received systemic corticosteroids (>10mg/day prednisone or equivalent) within 2 weeks prior to enrollment
  • Expected survival ≥ 12 weeks
  • Vital organ function within 1 week before enrollment meets the following criteria: (1) blood routine: white blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelet (PLT) ≥100×109/L; hemoglobin (HGB) ≥9.0 g/Dl (2) Liver function: aspartate transferase (AST) ≤2.5×ULN, alanine aminotransferase (ALT) ≤2.5×ULN. (3) Renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (creatinine) ≤1.5×ULN; serum bilirubin (TBIL) ≤2.5×ULN, alanine aminotransferase (ALT) ≤2.5×ULN, and in liver metastasis ≤5×ULN; serum bilirubin (TBIL) ≤1.5×ULN (except for Gilbert Syndrome ≤3×ULN); albumin (ALB) ≥30.0g/L (3) Renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (creatinine) ≤1.5×ULN. (3) Renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) ≥50 mL/minute (using the Cockcroft/Gault formula) (4) Coagulation function: international normalized ratio (INR) ≤1.5; activated partial coagulation time (APCT) ≥1.5; activated partial coagulation time (APCT) ≤1.5 (4) Coagulation function: international normalized ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5×ULN (5) Others: lipase ≤1.5×ULN; if lipase >1.5×ULN, the patient can be enrolled if there is no clinical or imaging evidence of pancreatitis; amylase ≤1.5×ULN; if amylase >1.5×ULN, the patient can be enrolled if there is no clinical or imaging evidence of pancreatitis; amylase ≤1.5×ULN; and amylase ≤1.5×ULN. or imaging evidence of pancreatitis can be enrolled. Alkaline phosphatase (ALP) ≤ 2.5 x ULN, and in subjects with bone metastases, ALP ≤ 5 x ULN (6) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%
  • Female patients who are non-surgically sterilized or of childbearing potential must have a negative serum HCG test within 72 hours prior to the first dose of study medication and must not be lactating, and must agree to use appropriate contraception (e.g., intrauterine device (IUD), birth control pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; male patients must agree to use appropriate contraceptive methods during the study treatment period and for 3 months after the end of the study treatment period. Male patients agree to use an appropriate method of contraception during and for 3 months after study treatment.

Who cannot join

  • Patients with histologic or cytopathologic diagnosis of adenosquamous carcinoma or complex SCLC.
  • Genetic tests suggesting ALK fusion, ROS1 fusion, BRAF mutation, ERBB2 (HER2) amplification/mutation, RET rearrangement, MET amplification/MET14 exon jumping mutation and NTRK fusion positivity.
  • Clinical manifestations of neurologic failure such as severe encephalopathy or treatment-related severe neurologic injury, such as chemical meningitis
  • Non-malignant neurologic diseases that would interfere with the evaluation of LM signs or symptoms
  • radiotherapy directed to the chest and whole brain completed within 4 weeks prior to enrollment (palliative radiotherapy to bone lesions completed prior to the first dose of study drug is permitted for enrollment)
  • toxicity due to prior antitumor therapy other than alopecia and malaise not recovered to CTCAE 5.0 ≤ grade 1 prior to enrollment. Some other toxicities due to prior antitumor therapy are not expected to resolve within the expected period and have long-term persistent sequelae
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  • patients with spinal cord compression that has not been cured or relieved by surgery and/or radiotherapy, or patients with previously diagnosed spinal cord compression that has been treated with compression insufficiency or total paralysis; patients with liver metastases who have received cryo- and radiofrequency ablation therapy and who still have clinically significant symptoms and abnormal hepatic function in the 4 weeks prior to enrollment
  • Presence of uncontrollable large amount of pleural effusion, pericardial effusion or ascites.
  • Presence of the following cardiac diseases: (1) cardiac function class III-IV according to NYHA cardiac function classification (2) unstable angina pectoris or electrocardiogram suggesting acute ischemia or myocardial infarction within 1 year (3) clinically significant supraventricular or ventricular arrhythmia and other conduction system abnormalities (including QTc interval greater than or equal to 450ms for men and ≥470ms for women) (4) clinically significant Pericardial and myocardial diseases
  • Inadequate bone marrow reserve or organ function
  • Treatment with systemic immunomodulators (including but not limited to thymidine, interferon, or interleukin-2) within 4 weeks prior to enrollment
  • Any active autoimmune disease or history of autoimmune disease; interstitial pneumonitis, drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or active pneumonia with clinical symptoms
  • active or uncontrolled serious infection (CTCAE 5.0 ≥ grade 2) and/or antibiotic treatment within 2 weeks prior to enrollment
  • Patients with active or undergoing treatment for tuberculosis
  • Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), history of hypertensive crisis or hypertensive encephalopathy
  • intracranial hemorrhage known to be unrelated to the tumor
  • imaging (CT or MRI) showing that the tumor invades large vessels or is poorly demarcated from them, or those who, in the opinion of the investigator, are predisposed to hemorrhage, with symptoms of hemoptysis or daily hemoptysis ≥ 2.5 mL within 3 months prior to screening
  • Have had an arterial/venous thrombotic event within 24 weeks prior to enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.
  • Invasive surgery within 4 weeks prior to enrollment
  • Receiving medication with bleeding tendency, such as aspirin (>325 mg/day), or using full-dose oral or parenteral anticoagulants or thrombolytic agents for 2 weeks prior to enrollment.
  • Genetic predisposition to bleeding or coagulation disorders; clinically significant bleeding symptoms in the 12 weeks prior to enrollment or disorders with a clear bleeding predisposition, such as gastrointestinal bleeding, positive fecal occult blood at screening, or vasculitis.
  • History of peptic ulcer, gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheo-esophageal fistula, or intra-abdominal abscess within 24 weeks prior to enrollment.
  • Urine routine suggests that urinary protein ≥++, and confirms that the quantitative amount of 24-hour urinary protein >1.0g
  • HBsAg positive and HBV DNA test value exceeds the upper limit of the normal reference value (1000 copies/mL or 100 IU/mL), or HCV positive (HCV RNA or HCV Ab test suggests acute and chronic infections); known history of HIV-positive disease.
  • Patients who have received a live vaccine within 12 weeks prior to enrollment
  • Known hypersensitivity to study drugs or excipients, known severe allergic reaction to any of the monoclonal antibodies
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Other concurrent malignancies ≤ 5 years prior to the first dose of study drug, with the exception of adequately treatable carcinoma in situ of the cervix, basal cell or squamous epithelial skin cancers, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery
  • Known severe mental illness, alcoholism, drug addiction or drug abuse, etc.
  • Have been treated with any other experimental drug or participated in another interventional clinical study ≤ 4 weeks prior to signing the ICF.
  • In the judgment of the investigator, the subject has other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require co-treatment, serious laboratory abnormalities, associated family or social factors, which may affect the safety of the subject, or the collection of data and samples.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shengcun Fang

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Lateral Ventricular Chemotherapy in Patients With Non-squamous NSCLC With Soft Meningeal Metastases Who Have Failed EGFR-TKI Therapy

This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer.

Read the detailed description

Despite the rapid progress of immune-combination therapy in lung cancer, immune-combination anti-vascular regimens after EGFR-TKI failure have not been explored in NSCLC LM, and further exploration of superior regimens targeting brain metastases is needed. Therefore, we plan to conduct an exploratory clinical study of adebenosumab in combination with famitinib and lateral ventricular chemotherapy in patients with non-squamous NSCLC with soft meningeal metastases who have failed EGFR-TKI therapy, with the aim of providing a more feasible and effective comprehensive treatment strategy for this group of patients.

Conditions
NSCLC
Being tested
Adebelimumab+Famitinib + FOLFIRI+Ariely

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adebelimumab+Famitinib + FOLFIRI+ArielyDrug

    Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with non-squamous NSCLC with soft meningeal metastases who have failed EGFR-TKI therapy

Study groups in NCT06332300
Study groupRoleWhat they receive
Adebelimumab+famitinib+chemotherapyExperimentalAdebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with non-squamous NSCLC with soft meningeal metastases who have failed EGFR-TKI therapy
Receives: Drug: Adebelimumab+Famitinib + FOLFIRI+Ariely

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective remission rates for flaccid meninges

    Measured: Two years of observation after enrollment

Secondary outcomes (4)

  1. iPFS

    Intracranial progression-free survival

    Measured: Two years of observation after enrollment

  2. iDoR

    Duration of intracranial relief

    Measured: Two years of observation after enrollment

  3. PFS

    Overall progression-free survival

    Measured: Two years of observation after enrollment

  4. OS

    overall survival

    Measured: Two years of observation after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Why it stopped: The study drug, Famitinib, was not marketed and the drug was not available.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06332300
Sponsor's protocol ID
ADBL-LC-003
Status last verified
Aug 2024
First submitted
12 Mar 2024
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebelimumab+Famitinib + FOLFIRI+Ariely in people with NSCLC, run by Jiangsu Province Nanjing Brain 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 10 inclusion and 31 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: withdrawn, as of the sponsor's last update on 9 Aug 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Two years of observation after enrollment). 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 NCT06332300.

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 9 Aug 2024.

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