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Non-Small Cell Lung CancerPhase 2NCT05485350

Anlotinib , Penpulimab Combined With SBRT for Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Anlotinib Hydrochloride, penpulimab and SBRT in people with Non-Small Cell Lung Cancer, run by Peking University Third Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will explore the effectiveness and safety of the combination therapy of anlotinib , penpulimab and SBRT in patients with metastatic non-small Cell Lung Cancer (NSCLC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Anlotinib Hydrochloride, penpulimab and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
12 Sep 2022to 15 Oct 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, no gender limit；
  • Histological or cytological diagnosis of stage IV non-small cell lung cancer（NSCLC）
  • The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up.
  • Patients with advanced NSCLC who have received one or two systemic treatments, and those who are unwilling to accept or cannot tolerate systemic chemotherapy can also be enrolled. If it is a driver gene mutation-positive (EGFR, ALK) patient, it must be accepted after receiving the corresponding targeted therapy resistance or intolerable toxicity, No secondary susceptible mutations were eligible for enrollment.
  • Has at least five disseminated lesions for SBRT , and measurable lesion that meets the RECISTv1.1 standard。
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
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  • The expected survival time ≥ 3 months;
  • The functions of important organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the research treatment): Absolute Neutrophil Count (ANC) ≥1.5×10 E+9/L, Hemoglobin (HB) ≥9g/dL, Platelets (PLT)≥90×10 E+9/L, Serum Albumin (ALB)≥2.8g/dL, Total Bilirubin (TBIL) ≤1.5 ULN, ALT、AST≤2.5 UILN(If abnormal liver function is caused by liver metastasis, ≤5 ULN), Serum creatinine sCr≤1.5 ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula) , Normal thyroid function;
  • For female subjects of childbearing potential, a serum pregnancy test should be performed within 7 days prior to the administration of the first study intervention (study drug, radiation therapy) and have a negative result. Subjects are required to agree to use highly effective contraception and continue until at least 120 days after discontinuation of trial treatment

Who cannot join

  • The lesion has received prior radiotherapy and is not suitable for SBRT;
  • Currently participating in interventional clinical research and treatment, or receiving other research drugs or treatment with research equipment within 4 weeks before the first administration;
  • Imaging (CT or MRI) shows evidence of tumour invasion of large blood vessels or poorly demarcated blood vessels or the presence of cavities and necrotic lesions in the lungs；
  • With active bleeding or perforation or a hereditary or acquired bleeding tendency present, with a daily haemoptysis of ≥2.5mL in the 3 months prior to screening.
  • Suffer from active autoimmune diseases that require hormone or immunomodulatory treatment;
  • Have received anti-tumor monoclonal antibodies (mAb) within 4 weeks before using the study drug for the first time, or the adverse events caused by the previously received drug have not recovered (ie ≤ grade 1 or reached the baseline level). Note: Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
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  • Patients with multiple factors that affect oral medications (eg, inability to swallow, chronic diarrhea, and intestinal obstruction).
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
  • Suffer from acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis, and HIV;
  • Suffer from uncontrolled clinical symptoms or diseases of the heart, such as:(1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;
  • Suffer from high blood pressure and cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg);
  • Live vaccines have been vaccinated within 4 weeks before the first use of the study drug.
  • Active or previously documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10mg/day prednisone or other equivalent therapeutic hormones), and still within 2 weeks before the first dose continue to use.
  • Have a history of active pulmonary tuberculosis. In patients suspected of having active TB, examination of chest X-ray, sputum, and exclusion by clinical symptoms and signs are required.
  • Has an active infection requiring systemic treatment.
  • Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence.
  • Past history of clear neurological or psychiatric disorders.
  • The investigator judged other situations not suitable for inclusion in this study.

Trial locations and contacts

No sites are listed yet.

hongqing zhuang contact

0086-13051776232

hongqingzhuang@163.com

About this study

Official title: A Single-arm Clinical Study of Anlotinib Combined With Penpulimab Plus SBRT in Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study will explore the effectiveness and safety of the combination therapy of anlotinib , penpulimab and SBRT in patients with metastatic non-small Cell Lung Cancer (NSCLC)

Being tested
Anlotinib Hydrochloride, penpulimab, SBRT
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.

  • Anlotinib HydrochlorideDrug

    Also called AL3818, Anlotinib Hydrochloride Capsules, FuKeWei

    12 mg/d, d1-14, q3w

  • penpulimabDrug

    Also called AK105

    200mg, ivgtt, d1, q3w

  • SBRTRadiation

    55-180Gy

Study groups in NCT05485350
Study groupRoleWhat they receive
Anlotinib combined with SBRT and penpulimabExperimentalNot described
Receives: Drug: Anlotinib Hydrochloride; Drug: penpulimab; Radiation: SBRT

What is being measured

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

  1. Progression-free Survival

    Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)

    Measured: Time Frame: up to approximately 2 year

Secondary outcomes (3)

  1. Objective response rate

    Proportion of patients with a complete or partial response as measured using RECIST 1.1 criteria

    Measured: Time Frame: up to approximately 1 year

  2. Overall Survival

    Time from enrollment until death due to any cause

    Measured: Time Frame: up to approximately 2 year

  3. incidence, type and severity of adverse events

    Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: Time Frame: up to approximately 2 year

Timeline

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

  1. First posted3 Aug 2022
  2. Study start12 Sep 2022 (estimated)
  3. Primary completion21 Sep 2023 (estimated)
  4. Study completion15 Oct 2024 (estimated)

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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485350
Sponsor's protocol ID
ALTER-L056
Status last verified
Apr 2022
First submitted
9 Jul 2022
Last updated
3 Aug 2022
Results posted
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 Anlotinib Hydrochloride, penpulimab and SBRT in people with Non-Small Cell Lung Cancer, run by Peking University Third Hospital.

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 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact hongqing zhuang (0086-13051776232, hongqingzhuang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: Time Frame: up to approximately 2 year). 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 NCT05485350.

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 3 Aug 2022.

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