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NSCLC Stage IVPhase 2NCT04507217

Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous NSCLC

A Phase 2 study testing Tislelizumab, Carboplatin, Pemetrexed in people with NSCLC Stage IV and Brain Metastases, run by Sun Yat-sen University at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC Stage IV, Brain Metastases, PD-1 Antibody
What is being tested?
Tislelizumab, Carboplatin, Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesChina
Study dates
15 Sep 2020to 30 Jan 2023
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

  • Disease-related inclusion criteria:
  • Histologically confirmed metastatic (Stage IV) not amenable to curative surgery or radiotherapy, non-squamous NSCLC according to American Joint Committee on Cancer (AJCC), 8th Edition.
  • Radiographically confirmed brain metastases;
  • No prior systemic treatment for stage IV NSCLC. (Bevacizumab administered for improving radiation-induced encephaledema during irradiating intracranial lesions is not considered as systemic therapy for stage IV NSCLC)
  • Patients with asymptomatic BM or symptoms can be controlled by low dose corticosteroids (≤ 10 mg/day of prednisone or equivalent) or antiepileptics drugs;
  • Patients with previous local treatment to BMs should be stable and suitable to receive the systemic treatment;
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  • ECOG PS: 0 ~ 1
  • Extracranial measurable target lesions (per RECIST v1.1)
  • Life expectancy ≥ 3 months
  • Have adequate hematology, clinical chemistry, and organ function as indicated by the following laboratory values (confirmed within 7 days prior to the first dose):
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L.
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal [ULN].
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
  • Serum total bilirubin ≤ 1.5 × ULN (total bilirubin must be < 3 × ULN for patients with Gilbert's syndrome).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN or AST and ALT ≤ 5 × ULN for patients with liver metastases.
  • General inclusion criteria:
  • Able to provide written ICF signed by patient or by his/her legally authorized representative or guardian and can understand and agree to comply with the study protocol and follow-up procedures.
  • Male or female, aged 18 ~ 75 years on the day of signing ICF. Female patients of childbearing potential and non-sterile male patients must be willing to use a highly effective method of birth control for the duration of the study and for at least 120 days after the last dose of tislelizumab.

Who cannot join

  • Disease-related exclusion criteria:
  • Received prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints inhibitors.
  • Received prior systemic chemotherapy for advanced disease.
  • Have EGFR mutation or ALK gene translocation.
  • Patients iwith BMs that have received systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other drugs to relieve or prevent symptoms of BMs.
  • Patients with intracranial metastases that are locally amenable.
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  • Have received any approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks prior to the first dose of study drug.
  • Have clinically uncontrolled pleural effusion or ascites that requires pleurocentesis or abdominal tapping for drainage within 2 weeks prior to the first dose of study drugs.
  • Active leptomeningeal metastasis.
  • History of allergic reactions to any study drugs and their excipients.
  • Creatinine clearance (Ccr) < 45 mL/min.
  • Patients with active viral hepatitis that requires treatment as judged by the investigator: a. chronic hepatitis B virus carriers with HBV DNA ≥ 500 IU/mL (2500 copies/mL) (The HBV DNA test will be performed only for patients who have a positive antibody to hepatitis B core antigen (anti-HBc antibody) test); b. patients who have positive hepatitis C virus (HCV) RNA results (The HCV RNA test will be performed only for patients testing positive for HCV antibody).
  • Active autoimmune diseases that requires systemic treatment and may impact study treatment as assessed by investigator.
  • Any condition that required extensive chronic treatment with either corticosteroids or any other immunosuppressive medications that may impact study treatment as assessed by investigator.
  • General exclusion criteria:
  • Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection, etc.; 1) Serious infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; 2) Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
  • Major surgery requiring general anesthesia within 4 weeks before first dose.
  • Underlying medical conditions or alcohol or drug abuse or dependence that are to be unfavorable for the administration of study drugs or may have affected the interpretation of the results or rendered the patient at high risk from treatment complications.
  • Concurrent participation in another therapeutic clinical study. Female patients who are pregnant, breastfeeding, or males and females patients planning to have child during the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Center of Sun-Yat Sen University (CCSYSU)

    Guangzhou, Guangdong, 510060

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning

Other trials in China

About this study

Official title: A Phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Pemetrexed/ Carboplatin in Patients With Brain Metastases of Non-squamous Non-small Cell Lung Cancer

This is a phase II, Open-Label, Multicenter, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined with Pemetrexed/ Carboplatin in Patients with Brain Metastases of Non-squamous Non-small Cell Lung Cancer. The primary end point is PFS, and secondary endpoint is ORR, OS, DoR and Neurocognitive impairment. during the study, the exploratory objectives including (1) PD-L1 expression, TMB, and other potential predictive biomarkers, correlated with response to treatment (2) Progression-free survival based on intracranial response (iPFS) according to RECIST 1.1 and RANO-BM

Being tested
Tislelizumab, Carboplatin, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Brain Neoplasms

What participants receive

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

  • Tislelizumab, Carboplatin, PemetrexedDrug

    Tislelizumab: 200mg administered intravenously (IV) on Day 1 of each 21-day cycle

    Carboplatin: AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles

    Pemetrexed: 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle

Study groups in NCT04507217
Study groupRoleWhat they receive
Eligible patientsExperimentaltislelizumab (200mg) in combination with pemetrexed (500mg/m2) and carboplatin (AUC=5) intravenously on day 1 of a 3-week cycle for 4 cycles. Afterwards, patients without disease progression were treated with maintenance treatment with tislelizumab (200mg) plus pemetrexed (500mg/m2) every 3 weeks up to 24 months or until disease progression, unacceptable toxicity, or death.
Receives: Drug: Tislelizumab, Carboplatin, Pemetrexed

What is being measured

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

  1. Progression-Free Survival (PFS) rate at 12 months according to RECIST v1.1

    Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first

    Measured: 12months

Secondary outcomes (7)

  1. Objective Response Rate (ORR) according to RECIST v1.1

    ORR is defined as the proportion (%) of patients with at least one visit response of complete response (CR) or partial response (PR).

    Measured: 36 months

  2. Progression-free survival (PFS) according to RECIST v1.1

    Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.

    Measured: 12 months

  3. Overall Survival (OS)

    OS is defined as the time from the starting date of study drug to the date of death due to any cause

    Measured: 36 months

  4. Progression-free survival (PFS) according to RANO-BM

    PFS2 is defined as the time from first intracranial disease progression to second/subsequent disease progression (intracranial or extracranial) after initiation of new anti-cancer therapy, or death from any cause, whichever occurs first

    Measured: 36 months

  5. Duration of Response (DoR) according to RECIST v1.1

    DoR is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first

    Measured: 36 months

  6. Incidence and severity of treatment-emergent AEs (TEAEs)

    TEAEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

    Measured: 36 months

  7. Neurocognitive impairment

    Neurocognitive impairment according to Hopkins Verbal Learning Test-Revised（HVLT-R）

    Measured: 36 months

Timeline

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

  1. First posted11 Aug 2020
  2. Study start15 Sep 2020
  3. Primary completion15 Nov 2022
  4. Study completion30 Jan 2023

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
Model description
Tislelizumab Combined with Pemetrexed/ Carboplatin
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507217
Sponsor's protocol ID
BGB-A317-2003-IIT
Status last verified
May 2023
First submitted
6 Aug 2020
Last updated
25 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Carboplatin, Pemetrexed in people with NSCLC Stage IV and Brain Metastases, run by Sun Yat-sen University at 2 sites 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 18 inclusion and 19 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: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-Free Survival (PFS) rate at 12 months according to RECIST v1.1 (time frame: 12months). 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 NCT04507217.

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 25 May 2023.

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