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Non-small Cell Lung CancerPhase 2NCT06452433

Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer.

A Phase 2 study testing gumarontinib and third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) in people with Non-small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. 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?
gumarontinib and third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 2 Feb 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

  • ≥18 years old.
  • Locally advanced or metastatic (stage IIIB-IV) NSCLC confirmed histologically or cytologically, stage III patients are unresectable and are not suitable for radical concurrent chemoradiotherapy.
  • ECOG 0~1.
  • Expected survival time ≥3 months
  • Patients with EGFR mutations known to be associated with drug sensitivity (i.e., exon 19 deletion or L858R mutation).
  • For advanced NSCLC, 2 or 3 generations of EGFR-TKI or EGFR-TKI (EGFR-TKI monotherapy, combination chemotherapy or bevacizumab are acceptable) have been treated with treatment failure, and EGFR-TKI has only been received as first-line therapy: Cohort 1: Third-generation EGFR-TKI therapy failed (EGFR-TKI monotherapy, combination chemotherapy, or bevacizumab could be used) without first - or second-generation EGFR-TKI therapy; Cohort 2: EGFR-TKI therapy failed in the first or second generation (EGFR-TKI monotherapy, combination chemotherapy, or bevacizumab were acceptable), and the status of T790M was not limited without the third generation of EGFR-TKI therapy or the first three generations of EGFR-TKI therapy < 4 weeks (28 days);
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  • Met the following criteria for EGFR-TKI treatment failure (acquired resistance): Continuous treatment with EGFR-TKI in the past; Treatment with EGFR-TKI resulted in any of the following objective clinical benefits (RECIST 1.1) ; Documented partial or complete remission; Clinical benefit for ≥6 months; Imaging disease progression during EGFR-TKI treatment (RECIST 1.1).
  • Specimens collected after treatment with EGFR-TKI for disease progression meet criteria for MET amplification (FISH GCN≥5 or MET/CEP7≥2, or NGS GCN≥2.3).
  • At least one measurable lesion according to RECIST 1.1 criteria.
  • Has recovered from adverse effects of any prior chemotherapy, surgery, radiation, or other antitumor therapy to CTCAE 5.0 ≤ Grade 1 or baseline (except for toxicities such as hair loss that the investigator determines are not a safety risk).
  • Normal bone marrow and organ function: Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥90×10^9/L, hemoglobin (Hb) ≥90g/L,patients whose hematological indexes were at a critical value and could not meet the above criteria were determined by the investigator according to the patient's physical condition; AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred;Total bilirubin ≤1 x ULN or ULN < total bilirubin ≤1.5 x ULN, and AST≤1 x ULN; Creatinine clearance >50 ml/min (calculated according to Cockroft-Gault)
  • Patients were fully aware of and volunteered to participate in the study.

Who cannot join

  • Patients who had previously been treated with MET inhibitors.
  • In addition to EGFR and MET, have gene mutations sensitive to other targeted drugs such as ALK and ROS1.
  • Patients who have previously received EGFR-TKI rechallenge therapy.
  • Study patients with neurologically unstable CNS metastases in the central nervous system who had symptoms related to brain metastases prior to treatment initiation, or who required increased steroid doses to control CNS disease (patients with controlled CNS metastases may participate in this trial).
  • The following medications are required 2 weeks prior to and during study therapy: drugs that may lead to prolonged QTc interval or tip torsive ventricular tachycardia, transporter MATE1, MATE2K substrate, and strong inducers of CYP3A4.
  • Present or past 5 years with other malignancies (except cured skin basal cell carcinoma, carcinoma in situ, etc.).
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  • Received other antitumor agents (except EGFR-TKI) within 5 half-lives prior to initial administration of the investigational drug; If the patient's last anti-tumor treatment prior to screening was third-generation EGFR-TKI, the patient may continue to receive third-generation EGFR-TKI until admission to the regimen without medication interruption.
  • Adverse effects did not recover after receiving extensive radiation therapy within 4 weeks of study treatment initiation or palliative local radiation therapy within 1 week of study treatment initiation.
  • Interstitial lung disease (ILD) or pneumonia requiring systemic steroid treatment.
  • Study received major surgery or significant trauma within 4 weeks before the start of treatment.
  • Hyperkinetic/venous thrombotic events or embolic events, such as stroke (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, occurred within 6 months before the first dose;
  • Patients with dysphagia, complete or incomplete digestive obstruction, active gastrointestinal bleeding, perforation, etc. affecting oral drug absorption (frequent vomiting, diarrhea, etc.);
  • In the 6 months prior to screening, cardiovascular disease met any of the following criteria: a) congestive heart failure ≥3 of the New York College of Cardiology (NYHA); Or left ventricular ejection fraction (LVEF) < 50%; b) severe arrhythmias requiring medical treatment; c) Screening period mean resting corrected QT interval (QTcF) > 470 ms for women or >450 ms for men (using the Fridericia formula [QTc = QT/(RR^0.33)], averaging results from three 12-lead ECG tests), or the presence of a risk factor for tip torsion ventricular tachycardia, For example, a family history of hypokalemia, long QT syndrome, or familial arrhythmia judged by the investigator to be clinically significant; d) Uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after treatment with standardized antihypertensive drugs); e) acute myocardial infarction, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting within 6 months prior to initial administration; f) Clinically significant arrhythmias.
  • An active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment, defined as persistent signs/symptoms associated with the infection that do not improve despite the use of appropriate antibiotics, antiviral therapy, and/or other treatment;
  • Patients with active hepatitis B (HbsAg or HBcAb positive and HBV DNA higher than the upper limit of normal), active hepatitis C (HCV antibody positive and HCV RNA higher than the upper limit of the study center), HIV antibody positive;
  • Known allergy or intolerance to therapeutic drugs or their excipients;
  • Pregnant or lactating women;
  • The investigator believes that the subjects are not suitable to participate in this clinical study for other reasons.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jie Wang, PhD contact

13910704669

jiewang_hr@sina.com

About this study

Official title: Gumarontinib Combined With Third-generation EGFR-TKI in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Amplification Following EGFR-TKI Treatment Failure.

This study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. The study was divided into 2 cohorts: Cohort 1 included patients with MET amplification after third-generation EGFR-TKI first-line therapy resistance, and cohort 2 included patients with MET amplification after first-generation EGFR-TKI first-line therapy resistance.

Read the detailed description

This study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. The study was divided into 2 cohorts: Cohort 1 included patients with MET amplification after third-generation EGFR-TKI first-line therapy resistance, and cohort 2 included patients with MET amplification after first-generation EGFR-TKI first-line therapy resistance. Patients will receive the combination until disease progression or intolerable toxicity. A total of 91 patients who met the inclusion and exclusion criteria were included in the study. The primary endpoint was ORR.

Being tested
gumarontinib, third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)
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.

  • gumarontinibDrug

    Also called SCC244

    300 mg , qd ,po, expect 6 months.

  • third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)Drug

    Also called third-generation EGFR-TKI

    According to the actual situation of patients. Take as recommended, expect 6 months.

Study groups in NCT06452433
Study groupRoleWhat they receive
Gumarontinib combined with third-generation EGFR-TKIExperimentalPatients were treated with Gumarontinib in combination with third-generation EGFR-TKI (Osmertinib,Almonertinib, Furmonertinib) oral therapy until disease progression or the onset of intolerable toxicity, treatment is expected to last 3-6 months.
Receives: Drug: gumarontinib; Drug: third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)

What is being measured

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

  1. Objective response rate

    To investigate antitumor efficacy of study, proportion of patients with complete (CR) or partial response (PR).

    Measured: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.

Secondary outcomes (5)

  1. Disease control rate

    To investigate antitumor efficacy of study, proportion of patients with complete , partial or stable response (SD).

    Measured: From initial medication to the date of first documented progression or end of medication, whichever came first, assessed up to 6 months.

  2. Duration of response

    Time from first achieving CR or PR to the onset of disease progression (PD) or death, whichever occurs first

    Measured: from first achieving CR or PR to the onset of disease progression (PD) or death, whichever occurs first, Assessed up to 36 months.

  3. Progression free survival

    To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.

    Measured: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 24 months.

  4. Overall survival

    To investigate antitumor efficacy of study. From initial medication to the date of death from any cause.

    Measured: From initial medication to the date of death from any cause. Assessed up to 36 months.

  5. Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0

    To assess the incidence and severity of adverse events in combination regimens.

    Measured: Assessed except to 10 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 Jun 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion12 Dec 2027 (estimated)
  4. Study completion2 Feb 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
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452433
Sponsor's protocol ID
CSPC-HYT-NSCLC-K03
Status last verified
Jun 2024
First submitted
5 Jun 2024
Last updated
11 Jun 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 gumarontinib and third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) in people with Non-small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 12 inclusion and 18 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: opening soon, as of the sponsor's last update on 11 Jun 2024. 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?

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?

Contact Jie Wang, PhD (13910704669, jiewang_hr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.). 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 NCT06452433.

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 11 Jun 2024.

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