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C-Met Exon 14 MutationPhase 1/2NCT04270591

Assessment of Anti-tumor and Safety in Glumetinib in Patients With c-MET-positive Non-Small Cell Lung Cancer

A Phase 1/2 study testing Glumetinib in people with C-Met Exon 14 Mutation, run by Haihe Biopharma Co., Ltd. at 44 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer Phase Ib (China only): Approximately 90 patients Phase Ⅱ (globally): Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only) Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
C-Met Exon 14 Mutation
What is being tested?
Glumetinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
44 sitesin 3 countries
Study dates
15 Jul 2019to 30 Dec 2023
Phase
Phase 1/2
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide informed consent voluntarily.
  • Male and female patients ≥ 18 years of age (or having reached the age of majority according to local laws and regulations, if the age is > 18 years).
  • Histologically or cytologically confirmed diagnosis of NSCLC including PSC.
  • Patients with stage IIIb or IIIc NSCLC who are not candidates for definitive surgical resection or concurrent chemoradiation or patients with stage IV NSCLC (AJCC version 8).
  • For Phase Ib study, patients should carry at least one of the following MET alterations (by local or Sponsor-designated central laboratory screening):
  • METex14 skipping mutation who had previously treated by other MET inhibitor(s) or
Show all 28Show fewer
  • METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC or
  • MET amplification GCN ≥ 4 or MET/CEP7 ratio ≥ 2) or
  • MET over-expression (IHC2+).
  • For Phase II study, patients with METex14 skipping mutation in tumor or ctDNA samples (local testing is acceptable for eligibility, however if the results of the central laboratory is available, the report of the central laboratory shall prevail); all patients in Phase II study will have confirmation of METex14 skipping mutation by Sponsor-designated central laboratory but this result is not necessary for eligibility.
  • Availability of tumor tissue sample (either fresh tumor biopsy or archival tumor tissue sample); for patients of phase II study (not mandatory for safety run-in), if screened and enrolled based on local test results of METex14 skipping, the tumor tissue sample must be available for central laboratory testing before C2D1; if local testing results meet the requirements, patients of phase Ib are exempt from the central laboratory confirm.
  • For Phase II study, patients are not eligible for chemotherapy or refuse chemotherapy after well-informed or have failed one or two prior lines of systemic therapies for the advanced NSCLC.
  • Treatment failure is defined as documented disease progression or intolerance to treatment.
  • Maintenance therapy given after first line chemotherapy will be considered as part of the first line if given to patients with documented response or stable disease before starting the maintenance therapy.
  • Prior neoadjuvant/adjuvant systematic therapies will count as one prior line of treatment, provided that disease recurred within 12 months of completion of neoadjuvant/adjuvant therapy.
  • For Phase II study, at least one measurable lesion as per RECIST 1.1. (A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation.)
  • ECOG Performance Status (PS): 0-1.
  • Adequate bone marrow reserve, renal and liver function:
  • Absolute neutrophil count ≥ 1.5 × 109/L;
  • Hemoglobin ≥ 9 g/dL;
  • Platelet count ≥ 75 × 109/L;
  • Serum total bilirubin ≤ ULN (≤ 3 × ULN for patients with Gilbert's syndrome);
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN for patients with hepatic metastasis);
  • Creatinine clearance (calculated* or measured value**) ≥ 50 mL/min
  • For calculated creatinine clearance (Ccr) value, the eligibility should be determined using the Cockcroft-Gault formula:
  • Male Ccr (mL/mim) = body weight (kg) x (140-age)/[72 x creatinine (mg/dL)]
  • Female Ccr (mL/min) = male Ccr x 0.85 ** A measured value
  • International normalized ratio (INR) < 1.3 (or < 3.0 if on anticoagulation)

Who cannot join

  • Patients who meet any of the following criteria shall be excluded from the study:
  • Patients with targetable activating EGFR mutation, ALK rearrangement, ROS1 rearrangement, BRAF mutation or NTRK fusion that have available standard of care therapies.
  • Patients who have symptomatic CNS metastasis which is neurologically unstable or those who have CNS disease requiring increase in the dose of steroid. (Note: Patients with controlled CNS metastasis can participate in the trial. Before entering the study, patients should have finished radiotherapy, or have received operation for CNS tumor metastasis at least two weeks before. Patients' neurological function must be in a stable state; no new neurological deficit is found during clinical examination and no new problem is found during CNS imaging examinations. If patients need to use steroids to treat CNS metastasis, the therapeutic dose of steroid should be stable for ≥ 3 months at least two weeks prior to entering the study with treatment dose no more than dexamethasone 4 mg daily or an equivalent dose of steroids.)
  • Prior exposure to MET-directed therapy (except patients harboring METex14 skipping in Phase Ib study).
  • Evidence of past or current primary malignancies other than NSCLC (except for non-melanoma skin cancer, in situ breast cancer or in situ cervical carcinoma and superficial bladder cancer, or other cancer curatively treated and with no evidence of disease for at least 5 years).
  • Subjects with clinically significant cardiovascular disease, including:
Show all 28Show fewer
  • NYHA Class III or higher congestive heart failure;
  • History or current evidence of serious uncontrolled ventricular arrhythmias requiring drug therapy;
  • Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass graft received within 6 months prior to the first dose;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Fridericia's corrected QT interval (QTcF) > 460 ms on ECG conducted during screening;
  • Congenital long QT syndrome, or any known history of torsade de pointes (TdP), or family history of unexplained sudden death;
  • Clinically uncontrolled hypertension (after standard antihypertensive treatment, systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  • Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 prior neuropathy.
  • Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C. Patients whose test results meet one of the following will not be enrolled:
  • for patients in China and Japan, confirmed HIV antibody positive. For patients in the US, patients with a history of HIV but no history of AIDS or an AIDS-defining opportunistic infection are allowed to be enrolled;
  • serum HBsAg positive and HBV DNA>200 IU/ml or 1000 copies/mL;
  • For patients in Japan, whose results are HBsAg antigen negative; however, when HBsAb or HBcAb positive, the patients whose HBV DNA < 200 IU/ml or 1000 copies/mL could be enrolled.
  • serum HCV antibody and HCV RNA positive.
  • Anticancer therapy (including chemotherapy, targeted therapy, biotherapy, hormone therapy or other investigational agents) within 4 weeks or 5 times of half-lives (whichever is shorter) prior to the first dose of the study drug or who have not recovered from the side effect of such therapy.
  • Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
  • Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product.
  • Patients who have to receive treatment (definite strong CYP3A4 inhibitor or inducer [appendix 6]; in addition, herbals/supplements containing St. John's wart [Hypericum perforatum L.] and Sevillia orange etc. should also be avoided.) that is prohibited during the study and those who cannot discontinue drugs (e.g. antiarrhythmic agent) that may lead to QTc interval prolongation or torsade de pointes. Additionally, patients who have to receive treatment of strong inhibitor for CYP2C8 and/or CYP2C9 [appendix 6] and substrates or inhibitor for transporter [appendix 7] will be excluded in safety run-in part of the study.
  • Any diseases or medical conditions, at the investigator's discretion, that may be unstable or influence their safety or study compliance, including organ transplantation, abuse of psychotropic medication, alcohol abuse or history of drug abuse.
  • Other serious illness or medical conditions at the investigator's discretion, that may influence study results, including but not limited to serious infection, diabetes, cardiovascular and cerebrovascular diseases or lung disease.
  • Patients with a history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD.
  • Pregnant or breast-feeding patients. Pregnancy refers to the state of a woman between fertilization and the end of pregnancy confirmed by positive laboratory hCG test (> 5 mIU/mL). Breast-feeding woman can become eligible for this study if she stops breast-feeding, however, cannot restart the breast-feeding on/after the completion of the study treatment.
  • Man and woman with childbearing potential (WOCBP refer to appendix 3) not using effective contraception (refer to appendix 3) during the trial and within 6 months after the end of treatment

Trial locations and contacts

44 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Shun LU, Doctor contact

+86-21-22200000ext2153

shun_lu@hotmail.com

44 sites in 3 countries

China31 sites, 31 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Shandong, 071000

    Aimin Zang

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

    Ziping Wang

    Recruiting

  • Beijing Cancer Hospita

    Beijing, Beijing Municipality, 100000

    Jian Fang

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000

    Li Zhang

    Recruiting

  • First Hospital of Jilin University

    Changchun, Jilin, 130000

    Jiuwei Cui

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Min Li

    Recruiting

  • Hunan Province Cancer Hospital

    Changsha, 410000

    Lin Wu

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Lu Li

    Recruiting

  • Union Medical College Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350000

    Xiaoyan Lin

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Chengzhi Zhou

    Recruiting

  • Hainan Cancer Hospital

    Haikou, Hainan, 570000

    Wen Dong

    Recruiting

  • The First Affiliated Hospital，College of of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Jianying Zhou

    Recruiting

  • Zhejiang Province Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Yiping Zhang

    Recruiting

  • Cancer Hospital Affiliated to Harbin Medical University

    Harbin, Heilongjiang, 150000

    Yan Yu

    Recruiting

  • Anhui Province Hospital

    Hefei, Anhui, 230000

    Lejie Cao

    Recruiting

  • The Chest Hospital of Anhui Province

    Hefei, Anhui, 230000

    Xuhong Min

    Recruiting

  • Shandong University Qilu Hospital

    Jinan, Shandong, 250000

    Xiuwen Wang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Wei Zhang

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210000

    Meiqi Shi

    Recruiting

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu, 210000

    Yongqian Shu

    Recruiting

  • Cancer Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi, 530000

    Qitao Yu

    Recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200000

    Chong Bai

    Recruiting

  • Fudan university Shanghai cancer center

    Shanghai, Shanghai Municipality, 200000

    Jialei Wang

    Recruiting

  • The Chest Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200000

    Shun Lu

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

    Xiaoling Li

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Dingzhi Huang

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300000

    Diansheng Zhong

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430000

    Yanping Hu

    Recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei, 430000

    Xiaorong Dong

    Recruiting

  • Henan Province Cancer Hospital

    Zhengzhou, Henan, 450000

    Yanqiu Zhao

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450000

    Xingya Li

    Recruiting

Other trials in China

Japan11 sites, 11 recruiting

  • Ehime University Hospital

    Ehime

    Naoyuki Nogami

    Recruiting

  • Kyushu University Hospital

    Fukuoka

    Isamu Okamoto

    Recruiting

  • Kanagawa Cancer Center

    Kanagawa

    Terufumi Kato

    Recruiting

  • Niigata Cancer Center Hospital

    Niigata

    Hiroshi Tanaka

    Recruiting

  • Kindai University Hospital

    Osaka

    Hidetoshi Hayashi, Dr

    Recruiting

  • Osaka International Cancer Institute

    Osaka

    Kazumi Nishino

    Recruiting

  • Hokkaido University Hospital

    Sapporo

    Jun Sakakibara

    Recruiting

  • Shizuoka Cancer Center

    Shizuoka

    Haruki Kobayashi

    Recruiting

  • National Cancer Center Hospital East

    Tokyo

    Koichi Goto

    Recruiting

  • National Cancer center

    Tokyo

    Yuki Shinno

    Recruiting

  • Tottori University Hospital

    Tottori

    Masahiro Kodani

    Recruiting

Other trials in Japan

United States2 sites, 2 recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40233

    Jaspreet Singh, Grewal

    Not yet recruiting

  • The Oncology Institute of Hope & Innovation

    Louisville, Kentucky, 40233

    Stephen, Huang

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glumetinib (SCC244), a Selective MET Inhibitor in Patients With Advanced Non-Small Cell Lung Cancer Harboring MET-alterations

Indication:Patients with Advanced c-MET-positive Non-Small Cell Lung Cancer

Phase Ib (China only):

Approximately 90 patients

Phase Ⅱ (globally):

Approximately 78 evaluable patients; addition of at least 6 patients in Safety Run-in (US only)

Read the detailed description

Phase Ib study population

Approximately 90 patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV) including pulmonary sarcomatoid carcinoma (PSC). All patients should carry at least one of the following MET alterations (confirmed by local or central laboratory):

  • Patients with METex14 skipping mutation who had previously treated by other MET inhibitor(s)
  • Patients with METex14 skipping mutation who had received 3 or more lines prior systemic therapies without MET inhibitor for the advanced NSCLC
  • Patients with MET amplification (GCN ≥ 4 or MET/CEP7 ratio ≥ 2)
  • Patients with MET over-expression (IHC2+) Phase II - Safety Run-in Population (US only) A minimum of 6 patients who meeting the eligibility for either Phase Ib or Phase II.

Phase II study population (globally) Approximately 78 evaluable patients with locally advanced or metastatic NSCLC (Stage IIIb, IIIc or IV, including PSC) harboring METex14 skipping mutation that have been pre-screened by local or Sponsor-designated central laboratory, who are not eligible for chemotherapy or refuse of chemotherapy after well-informed or have failed one or two prior lines of systemic therapies and have not had prior MET inhibitor for the advanced NSCLC.

Being tested
Glumetinib
Keywords
MET, MET amplification, MET over-expression, C-Met Exon 14

What participants receive

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

  • GlumetinibDrug

    Also called SCC244

    The investigational product will be orally administrated when fasting at dose level of 300mg QD

Study groups in NCT04270591
Study groupRoleWhat they receive
SCC244 300mgOtherPhase Ib: SCC244 300mg, QD Phase II: SCC244 300mg, QD
Receives: Drug: Glumetinib

What is being measured

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

  1. ORR

    ORR as determined by an Independent Radiology Review Committee (IRRC) according to RECIST Version 1.1.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. ORR(assessed as per investigators)

    ORR (assessed as per investigators)

    Measured: through study completion, an average of 1 year

  2. DOR

    DOR

    Measured: The time from the date of first documented partial response or complete response to progressive disease or death, an average of 6 months

  3. Efficacy of glumetinib

    OS

    Measured: Through study completion, an average of 1 year.

Timeline

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

  1. First posted17 Feb 2020
  2. Study start15 Jul 2019
  3. Primary completion25 Oct 2023 (estimated)
  4. Study completion30 Dec 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase Ib：300 mg QD Glumetinib Phase II：300 mg QD Glumetinib
Masking
None (open label)
Enrolment
183 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04270591
Sponsor's protocol ID
SCC244-108
Status last verified
Jul 2022
First submitted
7 Aug 2019
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.

    PubMed 11784875

  • Drilon AE CD, Ou S-H. Efficacy and safety of crizotinib in patients (pts) with dvanced MET exon 14-altered non-small cell lung cancer (NSCLC). J Clin Oncol. 2016; 34:suppl; abstr 108.

  • 6. Felip E HL, Patel JD. Tepotinib in patients with advanced non-small cell lung cancer harboring MET exon 14-skipping mutations: Phase II trial. . J Clin Oncol. 2018; 36:suppl; abstr 9016.

  • Yin L, Lu Y. [MET Exon 14 Skipping Mutations in Non-small Cell Lung Cancer]. Zhongguo Fei Ai Za Zhi. 2018 Jul 20;21(7):553-559. doi: 10.3779/j.issn.1009-3419.2018.07.09. Chinese.

    PubMed 30037377

  • Vuong HG, Ho ATN, Altibi AMA, Nakazawa T, Katoh R, Kondo T. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer - A systematic review and meta-analysis. Lung Cancer. 2018 Sep;123:76-82. doi: 10.1016/j.lungcan.2018.07.006. Epub 2018 Jul 6.

    PubMed 30089599

  • Liu SY, Gou LY, Li AN, Lou NN, Gao HF, Su J, Yang JJ, Zhang XC, Shao Y, Dong ZY, Zhou Q, Zhong WZ, Wu YL. The Unique Characteristics of MET Exon 14 Mutation in Chinese Patients with NSCLC. J Thorac Oncol. 2016 Sep;11(9):1503-10. doi: 10.1016/j.jtho.2016.05.016. Epub 2016 May 30.

    PubMed 27257131

  • Frampton GM, Ali SM, Rosenzweig M, Chmielecki J, Lu X, Bauer TM, Akimov M, Bufill JA, Lee C, Jentz D, Hoover R, Ou SH, Salgia R, Brennan T, Chalmers ZR, Jaeger S, Huang A, Elvin JA, Erlich R, Fichtenholtz A, Gowen KA, Greenbowe J, Johnson A, Khaira D, McMahon C, Sanford EM, Roels S, White J, Greshock J, Schlegel R, Lipson D, Yelensky R, Morosini D, Ross JS, Collisson E, Peters M, Stephens PJ, Miller VA. Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discov. 2015 Aug;5(8):850-9. doi: 10.1158/2159-8290.CD-15-0285. Epub 2015 May 13.

    PubMed 25971938

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

    PubMed 26808342

  • Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7.

    PubMed 20610543

  • Lu S, Yu Y, Zhou J, Li X, Goto K, Min X, Nishino K, Cui J, Wu L, Sakakibara J, Shu Y, Dong X, Li L, Yoneshima Y, Zhou C, Li X, Zhang Y, Huang D, Zang A, Zhang W, Wang X, Zhang L, Bai C, Fang J, Cao L, Zhao Y, Yu Y, Shi M, Zhong D, Li F, Duanmu W, Wang Y. Long-term follow-up results from the GLORY study: phase II study of gumarontinib in East Asian patients with MET exon 14 skipping mutated non-small cell lung cancer. Transl Lung Cancer Res. 2025 Sep 30;14(9):3924-3938. doi: 10.21037/tlcr-2025-638. Epub 2025 Sep 28.

    PubMed 41132955

  • Yu Y, Dong W, Shi Y, Wu R, Yu Q, Ye F, Zhou C, Dong X, Li X, Li Y, Li Z, Wu L, Pan Y, Shen H, Wu D, Xu Z, Wu J, Xu N, Qin Y, Zang A, Zhang J, Zhou J, Zhang X, Zhao Y, Li F, Wang H, Liu Q, Han Z, Li J, Lu S. A pooled analysis of clinical outcome in driver-gene negative non-small cell lung cancer patients with MET overexpression treated with gumarontinib. Ther Adv Med Oncol. 2024 Jul 31;16:17588359241264730. doi: 10.1177/17588359241264730. eCollection 2024.

    PubMed 39091606

  • Yu Y, Zhou J, Li X, Goto K, Min X, Nishino K, Cui J, Wu L, Sakakibara J, Shu Y, Dong X, Li L, Yoneshima Y, Zhou C, Li X, Zhang Y, Huang D, Zang A, Zhang W, Wang X, Zhang L, Bai C, Fang J, Cao L, Zhao Y, Yu Y, Shi M, Zhong D, Li F, Li M, Wu Q, Zhou J, Sun M, Lu S. Gumarontinib in patients with non-small-cell lung cancer harbouring MET exon 14 skipping mutations: a multicentre, single-arm, open-label, phase 1b/2 trial. EClinicalMedicine. 2023 Apr 6;59:101952. doi: 10.1016/j.eclinm.2023.101952. eCollection 2023 May.

    PubMed 37096188

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Glumetinib in people with C-Met Exon 14 Mutation, run by Haihe Biopharma Co., Ltd. at 44 sites in 3 countries.

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 28 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China, Japan, United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Shun LU, Doctor (+86-21-22200000ext2153, shun_lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: through study completion, an average of 1 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 NCT04270591, which also lists 13 linked publications.

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 1 Aug 2022.

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