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Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET OverexpressionPhase 2NCT06525350

A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel（Albumin Bound）Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer

A Phase 2 study testing Glumetinib tablets, HB1801 (docetaxel, albumin-bound） and Docetaxel in people with Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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
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Trial summary

This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection（Albumin Bound）(HB1801) in the treatment of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Glumetinib tablets, HB1801 (docetaxel, albumin-bound） and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
256 participants
Where
No sites listed yet
Study dates
Jul 2024to 25 Jun 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. Able to understand and voluntarily sign a written informed consent form;
  • 2. Age ≥ 18 years old, gender unlimited;
  • 3. Unresectable locally advanced or metastatic non-small cell lung cancer (IIIB, IIIC, or IV according to the 8th edition TNM staging standards of IASLC) confirmed by histology or cytology;
  • 4. Participants must provide tumor tissue samples that meet the testing requirements of the central laboratory, or agree to accept the tumor tissue biopsy, used for central laboratory testing of MET expression and amplification, and the development of MET associated diagnostic reagents;
  • 5. Confirmation of MET overexpression in tumor tissue specimens through the central laboratory designated by the sponsor;
  • 6. Driver genes alterations must be negative (including EGFR mutations, ALK fusion, ROS1 rearrangement fusion, BRAF V600 mutation, NTRK fusion, MET 14 exon skipping mutation, RET rearrangement, HER2 Mutations, KRAS activation mutations, etc.);
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  • 7. Previously received immunotherapy with PD-1/PD-L1 monoclonal antibody and platinum-containing chemotherapy (combination therapy or sequential therapy);
  • 8. At least one measurable lesion exists at the baseline that meets the definition of RECIST 1.1;
  • 9. ECOG performance score of 0 or 1;
  • 10.Expected survival time ≥ 3 months;
  • 11.Adequate organs and bone marrow function within 7 days prior to initial administration.

Who cannot join

  • 1. Previously received MET-targeted drug therapy;
  • 2. Previous treatments included docetaxel;
  • 3. Existence of meningeal metastasis, spinal cord compression, or active and untreated brain metastasis;
  • 4. Imaging evidence of clear tumor cavity, capsule or large vessel invasion, and tumor adjacent to important vascular structures , Which has been determined by researchers that there is a risk of fatal bleeding;
  • 5. Suffering from central squamous cell lung cancer with cavities or hemoptysis (>50 mL/d);
  • 6. Within 14 days before the first administration, there is an uncontrollable accumulation of serous cavity effusion that requires frequent drainage or medical intervention;
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  • 7. Adverse reactions from previous anti-tumor treatments (including radiotherapy) have not yet recovered to ≤ level 1(according to CTCAE 5.0) or baseline level (excluding toxicity assessed by researchers as having no safety risk such as hair loss, fatigue, pigmentation, etc);
  • 8. Suffering from other malignant tumors within 5 years prior to the first administration. (Except already treated local tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ);
  • 9. Received any systemic anti-tumor therapy within 28 days or 5 half-lives prior to initial administration (whichever is shorter) treatment, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs (including thymosin, interleukin-2, interferon, tumor necrosis factor, etc.), or other research drugs;
  • 10. Received radiation therapy involving the chest cavity within 28 days prior to the first administration, o received radiation therapy not involving the chest cavity within 14 days prior to the first administration;
  • 11. Received Chinese herbal medicine or traditional Chinese patent medicines for tumor control within 14 days before the first administration;
  • 12. Received potent cytochrome P450 3A4 (CYP3A4) inhibitor or induction within 14 days prior to initial administration or Patients who cannot suspend the use of CYP3A4 potent inhibitors during the study;
  • 13. Having undergone major surgery (excluding biopsy) or severe traumatic damage within 28 days before the first administration, or expected to undergo major surgery during the study;
  • 14. A history of gastrointestinal perforation and/or fistula, severe gastrointestinal ulcers or surgery, gastrointestinal dysfunction, or other diseases that may affect the absorption of experimental drugs within 6 months prior to the first administration;
  • 15. Existence of ≥ grade 2 edema and lymphedema that cannot be relieved through clinical intervention;
  • 16. Received live vaccine or attenuated live vaccine within 28 days prior to initial administration or planned to receive live vaccine or attenuated live vaccine during the study period;
  • 17. Within 14 days prior to the first administration, there is a need of systemic antibiotics, antifungal or antiviral for the treatment of severe chronic or active infections (including tuberculosis infections, etc.);
  • 18. Severe or uncontrollable cardiovascular diseases that require treatment 6 months before screening;
  • 19. Interstitial lung disease (ILD) or drug-induced interstitial pneumonia, non-infectious pneumonia, including radiation pneumonia, pulmonary fibrosis, or acute lung disease that require steroid treatment;
  • 20. History of immunodeficiency, including human immunodeficiency virus (HIV) infection or known acquired immunodeficiency history of AIDS, or other acquired or congenital immunodeficiency diseases, or organ transplantation history;
  • 21. Active hepatitis B, active hepatitis C, active syphilis or active Tuberculosis;
  • 22. History of autoimmune diseases;
  • 23. Previous serious illnesses;
  • 24.Known to have allergies or hypersensitivity reactions to any investigational drug or any investigational drug excipients, or other serious allergy history;
  • 25. Breastfeeding or pregnant women; The blood pregnancy test conducted by women with fertility within 7 days prior to enrollment in the trial is positive;
  • 26. Any male and female patients with fertility who refuse to use highly effective contraceptive methods during the entire trial period and 6 months after the last administration.

Trial locations and contacts

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

Clinical Trials Information Group officer contact

86-0311-69085587

ctr-contact@cspc.cn

About this study

Official title: A Randomized, Controlled, Open-label Phase Ⅱ Study to Evaluate the Safety, Tolerability, and Efficacy of the Combination of Glumetinib Tablets and Docetaxel for Injection（Albumin Bound）Verse Docetaxel in the Treatment of Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer Patients With MET Overexpression

This study consists of Stage 1 (including dose escalation and dose expansion) and Stage 2 (randomized controlled study). The main purpose of Stage 1 is to preliminarily evaluate the safety and tolerability of the combination of glumetinib Tablets and Docetaxel for Injection（Albumin Bound）(HB1801) in the treatment of MET-overexpressed non-small cell lung cancer (NSCLC); The main purpose of Stage 2 is to evaluate the efficacy of the combination of glumetinib tablets and HB1801 compared to glumetinib tablets monotherapy or docetaxel in the treatment of MET-expressed NSCLC.

Being tested
Glumetinib tablets, HB1801 (docetaxel, albumin-bound）, Docetaxel
Medical subject headings
Recurrence

What participants receive

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

  • Glumetinib tabletsDrug

    An ATP competitive, highly selective MET receptor tyrosine kinase inhibitor

  • HB1801 (docetaxel, albumin-bound）Drug

    An improved new formulations of docetaxel

  • DocetaxelDrug

    A chemotherapy drug

Study groups in NCT06525350
Study groupRoleWhat they receive
Glumetinib tablets+HB1801 combination treatment armExperimentalGlumetinib tablets RP2D PO QD, HB1801 RP2D iv Q3W until a treatment discontinuation criterion is met.
Receives: Drug: Glumetinib tablets; Drug: HB1801 (docetaxel, albumin-bound）
Glumetinib tablets monotherapy armExperimentalGlumetinib tablets RP2D PO QD until a treatment discontinuation criterion is met.
Receives: Drug: Glumetinib tablets
Docetaxel monotherapy armActive comparatorDocetaxel 75mg/m^2 iv Q3W until a treatment discontinuation criterion is met.
Receives: Drug: Docetaxel

What is being measured

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

  1. Dose-limiting toxicity(DLT) occurrence and incidence

    Measured: Up to approximately 48 months after the first participant is enrolled

  2. Recommended phase 2 dose(RP2D) of the combination therapy

    Measured: Up to approximately 48 months after the first participant is enrolled

  3. Adverse events (AE) and serious adverse events (SAE) occurrence and incidence

    Measured: Up to approximately 48 months after the first participant is enrolled

  4. Objective response rate (ORR) per RECIST 1.1

    Measured: Up to approximately 48 months after the first participant is enrolled

Secondary outcomes (8)

  1. Disease control rate (DCR) per RECIST 1.1

    Measured: Up to approximately 48 months after the first participant is enrolled

  2. Duration of response (DoR) per RECIST 1.1

    Measured: Up to approximately 48 months after the first participant is enrolled

  3. Progression free survival (PFS) per RECIST 1.1

    Measured: Up to approximately 48 months after the first participant is enrolled

  4. Blood drug concentrations of glumetinib and HB1801

    Measured: Up to approximately 48 months after the first participant is enrolled

  5. MET expression level

    Measured: Up to approximately 48 months after the first participant is enrolled

  6. MET amplification level

    Measured: Up to approximately 48 months after the first participant is enrolled

  7. Tumor-associated gene variations

    Measured: Up to approximately 48 months after the first participant is enrolled

  8. Overall survival(OS)

    Measured: Up to approximately 48 months after the first participant is enrolled

Timeline

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

  1. First posted29 Jul 2024
  2. Study startJul 2024 (estimated)
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion25 Jun 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
Randomised
Intervention model
Factorial
Model description
In stage 2, participants who meet the eligibility criteria are randomly assigned to the experimental group (glumetinib tablets+HB1801), factorial group (glumetinib tablets), and control group (docetaxel) in a 2:1:1 ratio.
Masking
None (open label)
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06525350
Sponsor's protocol ID
SYH2065-001
Status last verified
Jul 2024
First submitted
18 Jul 2024
Last updated
29 Jul 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 Glumetinib tablets, HB1801 (docetaxel, albumin-bound） and Docetaxel in people with Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..

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 11 inclusion and 26 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 29 Jul 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 Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity(DLT) occurrence and incidence (time frame: Up to approximately 48 months after the first participant is enrolled). The study lists 4 primary outcomes in all. 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 NCT06525350.

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 Jul 2024.

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