NSCLCPhase 2NCT06534762
Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
A Phase 2 study testing Mirabegron in people with NSCLC and SCLC, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NSCLC, SCLC, Colorectal Cancer
- What is being tested?
- Mirabegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 1 Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily participate in the study, sign informed consent, and have good compliance;
- 18-65 years old (including 18 and 65 years old);
- solid tumors confirmed by histology and/or cytology, and advanced metastatic tumors that are not feasible for surgical resection;
- Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors;
- For subjects who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;
- Recovery of previous treatment-related AEs to National Cancer Institute Terminology Criteria for Common Adverse Events (NCI-CTCAE)≤ Grade 1 (excluding alopecia);
Show all 10Show fewer
- According to RECIST 1.1 standard, there is at least one measurable lesion assessed by the research center, and the measurable lesion should be a lesion that has not received local treatment such as radiotherapy (the lesion located in the region of previous radiotherapy can also be regarded as a measurable lesion that meets the requirements if progress is confirmed);
- ECOG physical condition: 0-1;
- Expected survival ≥ 12 weeks;
- The function of major organs is normal, I .e. the following criteria are met (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor [CSF] treatment has been received within 14 days before the first study drug administration): blood test (absolute value of neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin concentration ≥ 9g/dL); Liver function test (bilirubin ≤ 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase ≤ 2.5 ×ULN, AST and ALT ≤ 5 ×ULN in case of liver metastasis); renal function (serum creatinine ≤ 1.5 ×ULN, or creatinine clearance rate (CCr)≥ 60 ml/min); coagulation function, international normalized ratio (INR)≤ 1.5 ×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤ 1.5 ×ULN; thyroid function, thyroid-stimulating hormone (TSH)≤ the upper limit of normal (ULN); FT3 and FT4 levels should be examined if abnormal, and FT3 and FT4 levels are normal; (11) Women of childbearing age must have a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective contraception during the study period and within 3 months after the last dose of study medication (e. g. IUDs, contraceptives or condoms; surgical sterilization is required for male subjects whose partner is a woman of childbearing age, alternatively, an effective method of contraception is recommended for the duration of the study and for 3 months after the last study dose.
Who cannot join
- Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely healed, β3 adrenoceptor agonist and corresponding clinical research drugs;
- those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;
- Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc;
- symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks before treatment, or fever of unknown origin> 38.5°C during screening/first dose;
- have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Within 3 months before treatment, there were obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding> 30 mL within 3 months, hematemesis, black stool, hematochezia), hemoptysis (fresh blood> 5 mL within 4 weeks), etc. or a venous/venous thrombotic event within 6 months prior to treatment, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; or the need for long-term anticoagulant therapy with warfarin or heparin, or the need for long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day);
Show all 18Show fewer
- The tumor is found to invade large vascular structures during screening, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judge that there is a greater risk of bleeding;
- Active heart disease, including myocardial infarction, severe/unstable angina pectoris, 6 months before treatment. Echocardiography left ventricular ejection fraction <50%, arrhythmia poorly controlled;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring frequent drainage after appropriate intervention;
- Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function progression, decreased thyroid function; Note:(1) Subjects whose thyroid function can only be controlled by hormone replacement therapy can be included;(2) Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma has been completely resolved, and no intervention can be included after adulthood;(3) Patients with asthma who require medical intervention with bronchodilators cannot be included;
- received treatment with live attenuated vaccine within 28 days prior to the first administration of the study drug;
- The patient has a known history of psychotropic substance abuse, alcohol abuse or drug abuse; a history of definite neurological or psychiatric disorders, including epilepsy or dementia
- tuberculosis infection history;
- known human immunodeficiency virus (HIV) infection;
- Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must exclude active HBV infection, I .e., HBV DNA positive (>1 × 104 copies/mL or> 2000 IU/mL);
- Known hepatitis C virus infection (HCV) and HCV RNA positive (>1 x 103 copies/mL), or other hepatitis, cirrhosis];
- Patients with renal injury: GFR<30 mL/min 1.73m2 or patients requiring hemodialysis
- any other medical condition, clinically significant metabolic, physical, or laboratory abnormality, which, in the investigator's judgment, would reasonably suspect that the patient has a disease or condition that is not appropriate for the study drug (e. g., having seizures requiring treatment, bladder outlet obstruction, anxiety), or would interfere with the interpretation of the study results, or place the patient in a high-risk situation, or patients considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Liu Yang, M.D., 13666601475, yangliuqq2003@163.com
Minghua Ge, M.D.
About this study
Official title: Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study
This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time.
Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.
Read the detailed description
Cohort A non-small cell lung cancer (NSCLC):
A1 non-squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) pemetrexed(500mg/m2) cisplatin(75mg/m2) or carboplatin (AUC 5) q3w, 4-6 cycles of induction chemotherapy, Sintilimab or tislelizumab + pemetrexed maintenance, q3w; A2 squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) nab-paclitaxel (100mg/m2 d1/8/15) carboplatin (AUC 5) q3w,4-6 cycles, Sintilimab or tislelizumab maintenance, q3w; Cohort B Small cell lung cancer (SCLC) Serplulimab (4.5 mg/kg, D1) Carboplatin (AUC 5,D1) Etoposide (100 mg/m 2, D1-3),q3w, Cycle 4-6, Serplulimab maintained q3w Cohort C Colorectal cancer XELOX + bevacizumab (7.5 mg/kg,D1),q3w,8 cycles, bevacizumab + capecitabine maintenance, q3w; XELOX: oxaliplatin(130mg/m2 intravenous infusion> 2h D1), capecitabine (1000mg/m2 oral bid,D1-14),q3w; If the primary tumor is in the left colon or rectum, RAS/BRAF is wild type, cetuximab (500mg/m2,D1) + mFOLFOX6 is also admitted.
mFOLFOX6: oxaliplatin(85mg/m2, intravenous infusion 2h,D1) LV(400mg/m2, intravenous infusion 2h,D1) 5-FU (400mg, intravenous push, D1, then 1200mg/(m2 * d)X2 days continuous intravenous infusion), 12 cycles, bevacizumab + capecitabine maintenance, q3w Cohort D Pancreatic cancer GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1,8, 15,q4w,6-8 cycles Adjustable GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1, 8,q3w,6-8 cycles Cohort E Triple-Negative Breast Cancer TX regimen: docetaxel(75mg/m2 D1),q3w or nab-paclitaxel(100-150mg/m2 D1,qw),capecitabine(1000mg/m2 oral bid,D1-14),q3w,6-8 cycles; capecitabine maintenance, q3w (taxmen treatment sensitive) GP regimen: GEM(1000mg/m2 ,D1, 8) cisplatin(75mg/m2 ,divided into D1-3) q3w (taxane treatment failure) Cohort F Diffuse large B- cell lymphoma R-CHOP 6 cycles then R 2 cycles; R-CHOP: rituximab(375mg/m2,D0) cyclophosphamide(750mg/m2 D1),doxorubicin(40-50mg/m2,D1) vincristine(1.4mg/m2 D1 ,maximum dose 2mg) prednisone(100mg,D1-5 mg), q3w Cohort G Head and neck squamous cell carcinoma G1 Recurrent/metastatic squamous cell carcinoma of head and neck (non-nasopharyngeal carcinoma) PF: Cisplatin(100mg/m2 D1) or Carboplatin(AUC 5 D1), 5-Fu(1000mg/m2 d1-4),q3w TP: paclitaxel(175mg/m2 D1) cisplatin (75mg/m2 d1), q3w G2 Recurrent/Metastatic Nasopharyngeal Squamous Cell Carcinoma GP+Camrelizumab or Tislelizumab: cisplatin(80mg/m2 d1) gemcitabine (1000mg/m2 d1,8), then camrelizumab or tislelizumab 200mg,q3w maintenance
- Conditions
- NSCLC, SCLC, Colorectal Cancer, Pancreas Cancer, TNBC - Triple-Negative Breast Cancer, DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- Mirabegron
- Keywords
- Lung Cancer, Pancreas Cancer, Breast Cancer, B cell lymphoma, Colorectal Cancer, Carcinoma of Head and Neck, Miraberon
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Triple Negative Breast Neoplasms, Dendritic Cell Sarcoma, Interdigitating, Squamous Cell Carcinoma of Head and Neck, Lung Neoplasms, Breast Neoplasms, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronBiological
To explore the efficacy and safety of milaberon combined with standard treatment in advanced solid tumors
| Study group | Role | What they receive |
|---|---|---|
| Miraberon | Experimental | Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued. Receives: Biological: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall objective tumor response rate
Measured: 3 years
DLT
Dose-limiting toxicity
Measured: 3 years
Secondary outcomes (5)
DCR
Disease control rate
Measured: 3 years
DOR
duration of response
Measured: 3 years
TTR
Median time to remission
Measured: 3 years
OS
overall survival
Measured: 3 years
PFS
Progression free Survial
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start15 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minghua Ge, Zhejiang Provincial People's Hospital
- Investigators
- Liu Yang, M.D., Study director, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534762
- Sponsor's protocol ID
- Miraberon
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Zheng RS, Chen R, Han BF, Wang SM, Li L, Sun KX, Zeng HM, Wei WW, He J. [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231. doi: 10.3760/cma.j.cn112152-20240119-00035. Chinese.
PubMed 38468501Vasan N, Baselga J, Hyman DM. A view on drug resistance in cancer. Nature. 2019 Nov;575(7782):299-309. doi: 10.1038/s41586-019-1730-1. Epub 2019 Nov 13.
PubMed 31723286Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.
PubMed 21376230Wang R, Hu Q, Wu Y, Guan N, Han X, Guan X. Intratumoral lipid metabolic reprogramming as a pro-tumoral regulator in the tumor milieu. Biochim Biophys Acta Rev Cancer. 2023 Sep;1878(5):188962. doi: 10.1016/j.bbcan.2023.188962. Epub 2023 Aug 2.
PubMed 37541532Jin HR, Wang J, Wang ZJ, Xi MJ, Xia BH, Deng K, Yang JL. Lipid metabolic reprogramming in tumor microenvironment: from mechanisms to therapeutics. J Hematol Oncol. 2023 Sep 12;16(1):103. doi: 10.1186/s13045-023-01498-2.
PubMed 37700339Seki T, Yang Y, Sun X, Lim S, Xie S, Guo Z, Xiong W, Kuroda M, Sakaue H, Hosaka K, Jing X, Yoshihara M, Qu L, Li X, Chen Y, Cao Y. Brown-fat-mediated tumour suppression by cold-altered global metabolism. Nature. 2022 Aug;608(7922):421-428. doi: 10.1038/s41586-022-05030-3. Epub 2022 Aug 3.
PubMed 35922508O'Mara AE, Johnson JW, Linderman JD, Brychta RJ, McGehee S, Fletcher LA, Fink YA, Kapuria D, Cassimatis TM, Kelsey N, Cero C, Sater ZA, Piccinini F, Baskin AS, Leitner BP, Cai H, Millo CM, Dieckmann W, Walter M, Javitt NB, Rotman Y, Walter PJ, Ader M, Bergman RN, Herscovitch P, Chen KY, Cypess AM. Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity. J Clin Invest. 2020 May 1;130(5):2209-2219. doi: 10.1172/JCI131126.
PubMed 31961826Sun X, Sui W, Mu Z, Xie S, Deng J, Li S, Seki T, Wu J, Jing X, He X, Wang Y, Li X, Yang Y, Huang P, Ge M, Cao Y. Mirabegron displays anticancer effects by globally browning adipose tissues. Nat Commun. 2023 Nov 22;14(1):7610. doi: 10.1038/s41467-023-43350-8.
PubMed 37993438
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study
- ClinicalTrials.gov ID
- NCT06534762
- Acronym / sponsor ID
- Miraberon
- Conditions
- NSCLC, SCLC, Colorectal Cancer, Pancreas Cancer, TNBC - Triple-Negative Breast Cancer, DLBCL - Diffuse Large B Cell Lymphoma
- Keywords
- Lung Cancer, Pancreas Cancer, Breast Cancer, B cell lymphoma, Colorectal Cancer, Carcinoma of Head and Neck, Miraberon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time.
Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.
Detailed description
Cohort A non-small cell lung cancer (NSCLC):
A1 non-squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) pemetrexed(500mg/m2) cisplatin(75mg/m2) or carboplatin (AUC 5) q3w, 4-6 cycles of induction chemotherapy, Sintilimab or tislelizumab + pemetrexed maintenance, q3w; A2 squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) nab-paclitaxel (100mg/m2 d1/8/15) carboplatin (AUC 5) q3w,4-6 cycles, Sintilimab or tislelizumab maintenance, q3w; Cohort B Small cell lung cancer (SCLC) Serplulimab (4.5 mg/kg, D1) Carboplatin (AUC 5,D1) Etoposide (100 mg/m 2, D1-3),q3w, Cycle 4-6, Serplulimab maintained q3w Cohort C Colorectal cancer XELOX + bevacizumab (7.5 mg/kg,D1),q3w,8 cycles, bevacizumab + capecitabine maintenance, q3w; XELOX: oxaliplatin(130mg/m2 intravenous infusion> 2h D1), capecitabine (1000mg/m2 oral bid,D1-14),q3w; If the primary tumor is in the left colon or rectum, RAS/BRAF is wild type, cetuximab (500mg/m2,D1) + mFOLFOX6 is also admitted.
mFOLFOX6: oxaliplatin(85mg/m2, intravenous infusion 2h,D1) LV(400mg/m2, intravenous infusion 2h,D1) 5-FU (400mg, intravenous push, D1, then 1200mg/(m2 * d)X2 days continuous intravenous infusion), 12 cycles, bevacizumab + capecitabine maintenance, q3w Cohort D Pancreatic cancer GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1,8, 15,q4w,6-8 cycles Adjustable GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1, 8,q3w,6-8 cycles Cohort E Triple-Negative Breast Cancer TX regimen: docetaxel(75mg/m2 D1),q3w or nab-paclitaxel(100-150mg/m2 D1,qw),capecitabine(1000mg/m2 oral bid,D1-14),q3w,6-8 cycles; capecitabine maintenance, q3w (taxmen treatment sensitive) GP regimen: GEM(1000mg/m2 ,D1, 8) cisplatin(75mg/m2 ,divided into D1-3) q3w (taxane treatment failure) Cohort F Diffuse large B- cell lymphoma R-CHOP 6 cycles then R 2 cycles; R-CHOP: rituximab(375mg/m2,D0) cyclophosphamide(750mg/m2 D1),doxorubicin(40-50mg/m2,D1) vincristine(1.4mg/m2 D1 ,maximum dose 2mg) prednisone(100mg,D1-5 mg), q3w Cohort G Head and neck squamous cell carcinoma G1 Recurrent/metastatic squamous cell carcinoma of head and neck (non-nasopharyngeal carcinoma) PF: Cisplatin(100mg/m2 D1) or Carboplatin(AUC 5 D1), 5-Fu(1000mg/m2 d1-4),q3w TP: paclitaxel(175mg/m2 D1) cisplatin (75mg/m2 d1), q3w G2 Recurrent/Metastatic Nasopharyngeal Squamous Cell Carcinoma GP+Camrelizumab or Tislelizumab: cisplatin(80mg/m2 d1) gemcitabine (1000mg/m2 d1,8), then camrelizumab or tislelizumab 200mg,q3w maintenance
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miraberon | Experimental | Biological: MirabegronSubjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients voluntarily participate in the study, sign informed consent, and have good compliance;
- 18-65 years old (including 18 and 65 years old);
- solid tumors confirmed by histology and/or cytology, and advanced metastatic tumors that are not feasible for surgical resection;
- Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors;
- For subjects who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;
Key exclusion criteria (18 listed)
- Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely healed, β3 adrenoceptor agonist and corresponding clinical research drugs;
- those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;
- Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc;
- symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks before treatment, or fever of unknown origin> 38.5°C during screening/first dose;
- have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronTo explore the efficacy and safety of milaberon combined with standard treatment in advanced solid tumors | Biological | Miraberon |
Primary outcome
ORR
Time frame: 3 years
Overall objective tumor response rate
DLT
Time frame: 3 years
Dose-limiting toxicity
5 secondary outcomes
DCR
Time frame: 3 years
DOR
Time frame: 3 years
TTR
Time frame: 3 years
OS
Time frame: 3 years
PFS
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 38468501Zheng RS, Chen R, Han BF, Wang SM, Li L, Sun KX, Zeng HM, Wei WW, He J. [Cancer incidence and mortality in China, 2022]. Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231. doi: 10.3760/cma.j.cn112152-20240119-00035. Chinese.
- Background: PubMed 31723286Vasan N, Baselga J, Hyman DM. A view on drug resistance in cancer. Nature. 2019 Nov;575(7782):299-309. doi: 10.1038/s41586-019-1730-1. Epub 2019 Nov 13.
- Background: PubMed 21376230Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013.
- Background: PubMed 37541532Wang R, Hu Q, Wu Y, Guan N, Han X, Guan X. Intratumoral lipid metabolic reprogramming as a pro-tumoral regulator in the tumor milieu. Biochim Biophys Acta Rev Cancer. 2023 Sep;1878(5):188962. doi: 10.1016/j.bbcan.2023.188962. Epub 2023 Aug 2.
- Background: PubMed 37700339Jin HR, Wang J, Wang ZJ, Xi MJ, Xia BH, Deng K, Yang JL. Lipid metabolic reprogramming in tumor microenvironment: from mechanisms to therapeutics. J Hematol Oncol. 2023 Sep 12;16(1):103. doi: 10.1186/s13045-023-01498-2.
- Background: PubMed 35922508Seki T, Yang Y, Sun X, Lim S, Xie S, Guo Z, Xiong W, Kuroda M, Sakaue H, Hosaka K, Jing X, Yoshihara M, Qu L, Li X, Chen Y, Cao Y. Brown-fat-mediated tumour suppression by cold-altered global metabolism. Nature. 2022 Aug;608(7922):421-428. doi: 10.1038/s41586-022-05030-3. Epub 2022 Aug 3.
- Background: PubMed 31961826O'Mara AE, Johnson JW, Linderman JD, Brychta RJ, McGehee S, Fletcher LA, Fink YA, Kapuria D, Cassimatis TM, Kelsey N, Cero C, Sater ZA, Piccinini F, Baskin AS, Leitner BP, Cai H, Millo CM, Dieckmann W, Walter M, Javitt NB, Rotman Y, Walter PJ, Ader M, Bergman RN, Herscovitch P, Chen KY, Cypess AM. Chronic mirabegron treatment increases human brown fat, HDL cholesterol, and insulin sensitivity. J Clin Invest. 2020 May 1;130(5):2209-2219. doi: 10.1172/JCI131126.
- Background: PubMed 37993438Sun X, Sui W, Mu Z, Xie S, Deng J, Li S, Seki T, Wu J, Jing X, He X, Wang Y, Li X, Yang Y, Huang P, Ge M, Cao Y. Mirabegron displays anticancer effects by globally browning adipose tissues. Nat Commun. 2023 Nov 22;14(1):7610. doi: 10.1038/s41467-023-43350-8.
- Individual participant dataSharing planned: No
Related trials for NSCLC
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liu Yang, M.D. study director
Zhejiang Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirabegron in people with NSCLC and SCLC, run by Zhejiang Provincial People's Hospital 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 10 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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?
Contact Liu Yang, M.D. (13666601475, yangliuqq2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 years). The study lists 2 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 NCT06534762, which also lists 9 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 2 Aug 2024.