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Non-Small-Cell Lung CancerPhase 2NCT06827145

Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC

A Phase 2 study testing Vebreltinib and Osimertinib in people with Non-Small-Cell Lung Cancer, run by National Cancer Center, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Prospective, open label, single arm study to evaluate the efficacy and safety of Vebreltinib combined with Osimertinib in the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR 21 L858R mutation 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?
Vebreltinib and Osimertinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
14 Oct 2024to Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 1. Signed an informed consent form.
  • 2. Patients aged ≥18.
  • 3. Histologically or cytologically confirmed locally or metastatic NSCLC.
  • 4.EGFR 21 L858R mutation.
  • 5.at least one measurable lesion according to RECIST 1.1 criteria.
  • 6.ECOG PS 0-1.
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  • 7.appropriate organ function.
  • 8.For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 7 days prior to receiving the first study drug administration .If there is a risk of conception, all subjects (male or female) must agree to use effective contraception from the time they sign an informed consent until 3 months after the final administration of the study drug.
  • 9.The expected survival is more than 3 months.

Who cannot join

  • 1.Patients with EGFR 19del mutation , ALK or ROS1 gene fusions.
  • 2. Patients with symptomatic, neurologically unstable central nervous system (CNS) metastases, or CNS diseases that require increased steroid doses to control.
  • 3. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.
  • 4.Previous treatment history meets one of the following criteria: 1)prior treated with systemic treatment. 2)The last administration of other anti-tumor drugs was less than 14 days or 5 half-life period before the initiation of study agents. 3)Received traditional Chinese medicine with anti-tumor indications within 1 week prior to initiation of treatment, 4)Thoracic radiotherapy to lung fields (including whole brain radiotherapy) ≤4 weeks prior to initiation of study treatment , for all other sites (except lung and whole brain) ≤2 weeks prior to initiation of study treatment. 5)Received major surgery within the past 4 weeks, or received resection of brain metastatic lesion within 2 weeks, or the side effects of such surgery have not yet been recovered.
  • 5.Previous anti-tumor therapy toxicity have not been recovered to ≤ Grade 1 (NCI-CTCAE 5.0) or baseline, except for alopecia, skin pigmentation and grade 2 peripheral neurotoxicity.
  • 6.Receive a potent inducer and/or potent inhibitor of CYP3A4 within 1 week prior to initiation of study drug or need receive a potent inducer and/or potent inhibitor of CYP3A4 during the study period.
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  • 7.Any serious or uncontrolled systemic disease, including, but not limited to, other serious or psychiatric disorders or laboratory abnormalities, in which the investigator determines that the study drug is not suitable for the patient or affects protocol adherence.
  • 8.Cardiac function and disease meet one of the following criterias: QTc > 470 ms, Severe cardiac arrhythmia; Any risk factors that increase the length of the QTc; New York College of Cardiology (NYHA) Heart function grade ≥3. Poorly controlled hypertension.
  • 9.Have a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring steroid therapy, or are currently receiving drug therapy or other clinical interventions, or have existing active interstitial lung disease.
  • 10.A history of thromboembolic or venous thromboembolic events (including myocardial infarction, cerebrovascular event or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolic event) in the 6 months prior to the initial study drug administration, Any life-threatening bleeding event (including treatment requiring blood transfusion, surgery or local treatment, and ongoing medication) was judged to have a bleeding tendency.
  • 11.Active gastrointestinal disorders (such as ulcerative lesions, uncontrolled nausea, vomiting, diarrhea, and malabsorption syndrome) or other conditions (such as inability to swallow the investigational agent, or prior major gastrointestinal surgery) may significantly affect the absorption, distribution, metabolism, or excretion of the oral investigational agent.
  • 12.Patients with poorly controlled pleural effusion, peritoneal effusion, or pericardial effusion were judged by the investigators to be unsuitable for inclusion.
  • 13.Any systemic disease that the investigator determines to require treatment .
  • 14.A history of acute or chronic pancreatitis, pancreatic surgery, or risk factors that may increase the risk of developing pancreatitis.
  • 15.Active infection, including but not limited to:infected with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) (HIV antibody positive), infected with syphilis, active tuberculosis, the presence of active infections (such as pneumonia) requiring systematic anti-infective therapy within 2 weeks before drug administration in the first study.
  • 16.Patients being treated with warfarin or any other anticoagulant, except low-dose warfarin (< 2 mg) for the prevention of central catheter-associated thrombosis;
  • 17.Participants with known hypersensitivity or contraindications to study drug of same class or any excipient of these agents.
  • 18.Pregnant or lactating women.
  • 19.Patients were currently enrolled in another clinical study or received another clinical study drug within 2 weeks prior to initiation of study treatment.
  • 20. Other circumstances that, in the judgment of the investigator, may affect the conduct of the clinical study and the determination of the results of the study or increase the risks associated with drug administration.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer insititue and Hospital of CHINESE ACADEMY OF MEDICAL SCIENCE

    Beijing

Other trials in China

About this study

Official title: An Open-label, Single-center, Single-arm Phase IIa Study to Evaluate the Safety and Efficacy of Vebreltinib in Combination with Osimertinib in Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer with EGFR 21 L858R Mutation

This is a Prospective, open label, single arm study to evaluate the efficacy and safety of Vebreltinib combined with Osimertinib in the treatment of locally advanced or metastatic non-small cell lung cancer with EGFR 21 L858R mutation

Being tested
Vebreltinib, Osimertinib
Keywords
NSCLC, EGFR, Vebreltinib
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.

  • VebreltinibDrug

    Also called PLB1001, Bozitinib

    Vebreltinib 100mg oral BID

  • OsimertinibDrug

    Osimertinib 80mg oral once daily.

Study groups in NCT06827145
Study groupRoleWhat they receive
Experimental ArmExperimentalAll patients received oral Vebreltinib 100mg BID plus Osimertinib 80mg once daily.
Receives: Drug: Vebreltinib; Drug: Osimertinib

What is being measured

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

  1. Progression-free survival

    From the first treatment to the date of first documentation of disease progression, or death due to any cause

    Measured: 3 years

Secondary outcomes (4)

  1. Overall Response Rate

    ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.

    Measured: 3 years

  2. Overall survival

    From the first administration to death from any cause

    Measured: 5 years

  3. Duration of Response

    DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by the investigator or death in the absence of disease progression.

    Measured: 3 years

  4. Incidence of Treatment-Emergent Adverse Events

    A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

    Measured: 3 years

Timeline

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

  1. First posted14 Feb 2025
  2. Study start14 Oct 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2028 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827145
Sponsor's protocol ID
NCC4728
Status last verified
Aug 2024
First submitted
10 Feb 2025
Last updated
14 Feb 2025
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 Vebreltinib and Osimertinib in people with Non-Small-Cell Lung Cancer, run by National Cancer Center, China 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 9 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 14 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 3 years). 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 NCT06827145.

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 14 Feb 2025.

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