Health TrialsbyHealthPanel

Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC

ConditionLung Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital

About this trial

To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign a written informed consent form (ICF) to participate in the study; be willing and able to comply with study-related visits and procedures.

Male or female subjects aged 18 years or older.

Pathologically confirmed non-small cell lung cancer (NSCLC); outside hospital pathology reports are acceptable.

Newly diagnosed metastatic NSCLC (clinical Stage IVA or IVB) or recurrent NSCLC (staged in accordance with the AJCC Cancer Staging Manual 9th edition), not eligible for curative-intent surgery or radiotherapy.

Disqualifiers

Spinal cord compression. Symptomatic or unstable brain metastases, unless the patient has completed curative treatment, is not receiving corticosteroid therapy, and has maintained a stable neurological status for at least 2 weeks after completion of curative treatment and steroid therapy. Patients with asymptomatic brain metastases may be included if the investigator determines there is no immediate indication for curative treatment.

Diagnosis of another active malignancy requiring treatment within the past 3 years, other than NSCLC. Excluded are completely resected basal cell and squamous cell skin cancer, and completely resected carcinoma in situ of any type.

Known hypersensitivity to drugs of the same class as the study drug or to any of its excipients.

Any concurrent medical condition that may increase the risk of toxicity.

Trial design

Design model

Single group

Treatments tested in this trial

  • Vebreltinib

    Drug

    vebreltinib，150mg，oral，bid

  • Chemotherapy

    Drug

    Administered in accordance with the approved label

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: vebreltinib+ platinum-based chemotherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit.

Time frame
up to 24 months

Secondary outcomes

1

PFS

Progression-free survival

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
2

DCR

Disease Control Rate

Time frame
Each 42 days up to intolerance the toxicity or PD (up to 24 months
3

OS

Overall survival

Time frame
From randomization until death (up to 24 months)
4

AE

Adverse event

Time frame
From randomization until death (up to 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Chest Hospital

Lead sponsor

Shanghai Chest Hospital of Shanghai Jiao Tong University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: