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Non-small Cell Lung CancerPhase 2NCT05176925

Tislelizumab Combined With Sitravatinib as Consolidation Treatment Following Concurrent Chemoradiation in Patients With Locally Advanced, Unresectable NSCLC

A Phase 2 study testing Tislelizumab and Sitravatinib in people with Non-small Cell Lung Cancer, run by Fudan University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to evaluate the 1-year progression free survival (PFS) rate of tislelizumab combined with sitravatinib as assessed by investigators per RECIST 1.1. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Tislelizumab and Sitravatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
10 Jan 2021to 28 Sep 2022
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

  • ECOG performance status≤1.
  • Life expectancy ≥ 3 months.
  • Eligible patients for this study must have locally advanced, Stage III NSCLC that is considered unresectable. histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). Patients must not have progressed following definitive, platinum-based, concurrent chemoradiation therapy.
  • First dose of study treatment is no later than 42 days after cCRT.
  • Adequate organ function as indicated by the following laboratory values (obtained ≤ 7 days before first dose)
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L,
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  • Platelets ≥ 100 × 10^9/L,
  • Hemoglobin ≥ 90 g/L.
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x upper limit of normal (ULN).
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
  • Serum total bilirubin ≤ 1.5 x ULN.
  • Aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 x ULN.
  • Serum albumin ≥25 g/L（2.5 g/dL).
  • Serum creatinine ≤ 1.5 x ULN or estimated glomerular. filtration rate (GFR) >50 mL/min by Cockcroft-Gault equation.
  • Able to provide written informed consent by the patient or by the patient's legally acceptable representative and can understand and agree to comply with the requirements of the study.
  • Patients of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drugs.

Who cannot join

  • Mixed small cell and non-small cell lung cancer histology.
  • Received prior anti-VEGF mAb or VEGFR TKI agents and prior therapies targeting PD-1, PD-L1, CTLA-4 or other immune checkpoints.
  • Have any unresolved AE≥Grade 2 from prior cCRT，radiotherapy induced hearing loss, hair loss, peripheral sensory neuropathy and fatigue is excluded.
  • Grade ≥2 radiation pneumonitis while receiving cCRT.
  • Patients with known EGFR mutation, or ALK or ROS1 rearrangement.
  • Treatment with any approved systemic anti-cancer therapy or systemic immune-stimulatory agents (including but not limited to interferons, interleukin IL-2, and tumor necrosis factor) within 4 weeks prior to initiation of study treatment.
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  • Administration of live vaccine ≤ 4 weeks before the first dose of study treatment.
  • History of allergic reactions to any study drugs.
  • Patients with untreated chronic hepatitis B (HBV) or chronic HBV carriers whose HBV DNA ≥ 500 IU/mL, patients with active hepatitis C (HCV).
  • Active autoimmune diseases that require treatment and may affect study treatment estimated by investigator.
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or any other immunosuppressive medication≤ 14 days before first dose of study drugs that may affect study treatment estimated by investigator.
  • Severe chronic or active infections requiring systemic antibacterial, antifungal, within 14 days prior to first dose of study drug(s).
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • Any of the following cardiovascular risk criteria:
  • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drugs.
  • Symptomatic pulmonary embolism ≤ 28 days before first dose of study drugs.
  • Any history of acute myocardial infarction ≤ 6 months before first dose of study drugs.
  • Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drugs.
  • Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drugs.
  • Any history of cerebrovascular accident ≤ 6 months before first dose of study drugs.
  • QTc interval (corrected by Fridericia's method) > 450 msec (for males)/ > 470 msec (for females). Note: If QTc interval is > ULN on initial ECG, a follow up ECG will be performed to exclude result.
  • Current left ventricular ejection fraction (LVEF) < institutional LLN as assessed by echocardiography (ECHO).
  • Any episode of syncope or seizure ≤ 28 days before the first dose of study drug(s).
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg).
  • Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring within 6 months before first dose of study drugs.
  • Regardless of the severity, patients with any signs or medical history of bleeding; within 4 weeks prior to allocation, patients with any bleeding events ≥ CTCAE level 3, unhealed wounds, ulcers, or fractures.
  • Hemoptysis>50ml/d.
  • With central cavitation or tumor shown by imaging to be located around important vascular structures or if the investigator determines that the tumor is likely to invade important blood vessels and may cause fatal bleeding.
  • Inability to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Patients requiring treatment with gastric pH-modifying medications including proton pump inhibitors and/or H2 antagonist medications. Patients may switch to use of antacids.
  • History of uncontrolled diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
  • Significant history or clinical manifestation of any organ systems disorder, as determined by the investigator.
  • Any major surgical procedure requiring general anesthesia≤28 days before initiation of study treatment.
  • Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct.
  • Known history of HIV infection.
  • Any active malignancy≤2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
  • Pregnant or breastfeeding woman.
  • Concurrent participation in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Phase II, Open-Label, Single-Arm, Prospective Clinical Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Consolidation Treatment in Patients With Locally Advanced, Unresectable NSCLC Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy

This study aims to evaluate the 1-year progression free survival (PFS) rate of tislelizumab combined with sitravatinib as assessed by investigators per RECIST 1.1.

Being tested
Tislelizumab, Sitravatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • TislelizumabDrug

    Tislelizumab 200mg IV D1, Q3W

  • SitravatinibDrug

    The starting dose of sitravatinib in this study is 70 mg, oral once daily. After receiving 2 cycles of starting dose at 70 mg once daily with sitravatinib, if patients were tolerated well with study treatment (without AEs definitely related to sitravatinib nor TRAEs leading to sitravatinib dose reduction and interruption), it is recommended to escalate sitravatinib dose to 100 mg once daily at the discretion of the investigators after discussion with patients.

Study groups in NCT05176925
Study groupRoleWhat they receive
Tislelizumab combined with sitravatinibExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Sitravatinib

What is being measured

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

  1. 1-year Progression-Free-Survival (PFS) rate assessed by investigators per RECIST 1.1

    PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.

    Measured: Start of treatment until 1-year follow-up

Secondary outcomes (7)

  1. PFS (Progression-Free-Survival)

    From date of treatment start until the date of progression or the date of death due to any cause, evaluated according to RECIST 1.1 criteria,

    Measured: Up to 4 years

  2. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: Up to 4 years

  3. Duration of Response (DOR)

    Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria

    Measured: Up to 4 years

  4. DCR (Disease Control Rate)

    Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD), evaluated according to RECIST 1.1 criteria.

    Measured: Up to 4 years

  5. OS (Overall Survival)

    From date of treatment start to any cause death or last follow-up.

    Measured: From date of treatment start until the date of death from any cause or censored at the last day that the subjects are documented to be alive, whichever came first, assessed up to 4 years.

  6. Time to Distant Metastasis (TTDM)

    From date of treatment start to distant metastasis.

    Measured: Up to 4 years.

  7. Adverse events (per CTCAE v5.0 criteria)

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

    Measured: Up to 4 years

Timeline

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

  1. First posted4 Jan 2022
  2. Study start10 Jan 2021
  3. Primary completion27 Jun 2022
  4. Study completion28 Sep 2022

Why it stopped: The trial was terminated per sponsor recommendation

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05176925
Sponsor's protocol ID
2111245-17
Status last verified
Jan 2024
First submitted
15 Dec 2021
Last updated
29 Jan 2024
Results posted
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 and Sitravatinib in people with Non-small Cell Lung Cancer, run by Fudan University 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 16 inclusion and 38 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: stopped early, as of the sponsor's last update on 29 Jan 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 stopped early (reason given: The trial was terminated per sponsor recommendation). Results are not available in the source record.

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?

1-year Progression-Free-Survival (PFS) rate assessed by investigators per RECIST 1.1 (time frame: Start of treatment until 1-year follow-up). 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 NCT05176925.

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 29 Jan 2024.

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