Clinical Trials List
Protocol NumberJ2R-MC-YAAD
NCT Number(ClinicalTrials.gov Identfier)NCT07169851
Active
2025-11-01 - 2027-08-22
Phase II
Recruiting5
A phase 2, double-blind, placebo-controlled trial evaluating LY3537021 in adult participants with chemotherapy-induced nausea and vomiting due to malignant disease.
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly Taiwan
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/06
Investigators and Locations
Co-Principal Investigator
- Kuo-Ting Lee Division of General Surgery
- Shang-Hung Chen Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Zhu-Jun Loh Division of General Surgery
- 楊舜如 Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 曹朝榮 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 陳冠宇 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Meng-Jer Hsieh Division of Hematology & Oncology
- 蔡郁棻 Division of Hematology & Oncology
- 柯建佑 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chia-Hsun Hsieh
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- Ming-Mo Hou Division of Hematology & Oncology
- Wen-Chi Chou Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- 黃文冠 Division of Hematology & Oncology
- Chan-Keng Yang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chemotherapy-induced nausea and vomiting
Objectives
The purpose of this trial is to confirm the efficacy and safety of LY35327021 in controlling chemotherapy-induced nausea and vomiting. Participants will continue the trial until all parts are completed, which may take approximately two months.
Test Drug
LY3537021
Active Ingredient
LY3537021
Dosage Form
subcutaneous injection
Dosage
mg/ml
Endpoints
The proportion of participants who achieved a complete response during the trial delay period was defined as those who did not vomit or use rescue medication 24 to 120 hours after their first chemotherapy infusion.
Inclution Criteria
Participants must meet all of the following applicable criteria to be enrolled in the trial:
Age
1. Must be 18 years of age or older at the time of signing the informed consent form, or the legal age of consent under the jurisdiction where the trial will be conducted.
Participant Type and Disease Characteristics
2. Histologically or cytologically confirmed cancer.
3. Scheduled to receive anthracycline and cyclophosphamide (AC) or platinum-based chemotherapy at a dose ≥ 70 mg/m² on Day 1 of each cycle.
4. Life expectancy greater than 6 months.
5. Performance status score of 0 to 2 from the East Coast Cancer Clinical Research Consortium.
6. In accordance with the National Comprehensive Cancer Network (NCCN) 2025 Edition 1 guidelines for chemotherapy-induced nausea and vomiting (CINV), the participant is able to receive treatment for CINV with 5-HT3 (5-hydroxytryptamine subtype 3) receptor antagonists, NK1 (neurokinin-1) receptor antagonists, and dexamethasone (a corticosteroid). Exceptions may be granted regarding dosage and schedule, subject to local instructions.
7. The participant has adequate hematopoietic and organ function and is able to receive platinum-based or AC treatment regimens as determined by applicable guidelines and the trial administrator.
8. All liver, kidney, and pancreatic laboratory parameters are adequate.
Contraception/Barrier Method Requirements
9. Willingness to adhere to contraceptive requirements.
The contraceptive method used by the participant should comply with local regulations regarding contraceptive methods used by participants in clinical trials. Please refer to the section "(VIII) Contraindications, Restrictions, and Compliance Required for Participants During the Trial" and the paragraph "If you or your sexual partner may become pregnant, the guidelines below apply."
Informed Consent
10. Able to sign informed consent, including complying with the Informed Consent Form (ICF) and the provisions and restrictions listed in this trial plan.
Age
1. Must be 18 years of age or older at the time of signing the informed consent form, or the legal age of consent under the jurisdiction where the trial will be conducted.
Participant Type and Disease Characteristics
2. Histologically or cytologically confirmed cancer.
3. Scheduled to receive anthracycline and cyclophosphamide (AC) or platinum-based chemotherapy at a dose ≥ 70 mg/m² on Day 1 of each cycle.
4. Life expectancy greater than 6 months.
5. Performance status score of 0 to 2 from the East Coast Cancer Clinical Research Consortium.
6. In accordance with the National Comprehensive Cancer Network (NCCN) 2025 Edition 1 guidelines for chemotherapy-induced nausea and vomiting (CINV), the participant is able to receive treatment for CINV with 5-HT3 (5-hydroxytryptamine subtype 3) receptor antagonists, NK1 (neurokinin-1) receptor antagonists, and dexamethasone (a corticosteroid). Exceptions may be granted regarding dosage and schedule, subject to local instructions.
7. The participant has adequate hematopoietic and organ function and is able to receive platinum-based or AC treatment regimens as determined by applicable guidelines and the trial administrator.
8. All liver, kidney, and pancreatic laboratory parameters are adequate.
Contraception/Barrier Method Requirements
9. Willingness to adhere to contraceptive requirements.
The contraceptive method used by the participant should comply with local regulations regarding contraceptive methods used by participants in clinical trials. Please refer to the section "(VIII) Contraindications, Restrictions, and Compliance Required for Participants During the Trial" and the paragraph "If you or your sexual partner may become pregnant, the guidelines below apply."
Informed Consent
10. Able to sign informed consent, including complying with the Informed Consent Form (ICF) and the provisions and restrictions listed in this trial plan.
Exclusion Criteria
Participants will be excluded from this trial if they meet any of the following criteria: Medical Conditions
11. Metastasis to the Central Nervous System (CNS), except for asymptomatic brain or spinal metastases receiving specific treatment.
12. Known hypersensitivity or contraindication to 5-HT3 receptor antagonists, NK1 receptor antagonists, or dexamethasone.
13. Diagnosed with uncontrolled diabetes mellitus, defined as glycated hemoglobin (HbA1c) ≥ 8% or a history of severe hypoglycemia within the past 3 months.
Exception: Participants with medically controlled type 1 or 2 diabetes currently receiving insulin or other antihyperglycemic agents.
14. Current evidence suggests a clinically significant cardiac condition or a related history, which may increase the risk of participation in the trial or potentially confound electrocardiogram (ECG) data analysis.
15. Conditions related to QT/QTcF (corrected QT interval).
16. A known family or personal history of medullary thyroid carcinoma or type 2 multiple endocrine neoplasia syndrome.
17. Signs or symptoms of thyroid tumors, such as a neck mass, dysphagia, dyspnea, or persistent hoarseness (without other identifiable cause), or elevated serum calcitonin levels > 35 ng/L.
18. Thyroid-stimulating hormone (TSH) levels exceeding the normal range according to local laboratory standards.
Exception: Participants receiving treatment for hypothyroidism and having been on a stable dose for at least 6 months prior to screening.
19. At screening, an active hepatitis B test result is defined as a positive hepatitis B surface antigen (HBsAg) and/or a positive hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) result. Unless required by local regulations, participants without a history of HBV do not need to undergo HBV screening.
Exception: Participants who have been treated for HBV/have chronic HBV and are HBsAg positive, provided that:
• they received an approved course of suppressive antiviral therapy before Cycle 1 Day 1 (C1D1);
• they were on the same antiviral therapy throughout the trial; and
• HBV DNA was undetectable for ≤ 14 days before C1D1.
20. Infection with Hepatitis C virus (HCV), defined as a positive anti-HCV antibody test, with certain exceptions. Unless required by local guidelines, participants without a history of HCV do not need to undergo HCV screening.
21. Known infection with Human Immunodeficiency Virus (HIV) and untreated, with certain exceptions. Unless required by local guidelines, HIV screening is not required.
22. Known active CMV infection confirmed by cytomegalovirus (CMV) PCR testing.
23. Current or significant medical history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or nervous system conditions that may:
• significantly alter drug absorption, metabolism, or elimination;
• pose a risk during experimental treatment; or
• interfere with data interpretation. 24. A history of nausea and vomiting due to other non-malignant medical conditions, potentially leading to nausea, retching, or vomiting, or a history of anticipatory nausea and vomiting.
25. Hypercalcemia as defined by local laboratory standards.
26. A history of long-term alcohol abuse, intravenous drug abuse, or illicit drug abuse within the year prior to screening.
27. Scheduled for bone marrow transplantation or stem cell rescue therapy.
28. Scheduled for major surgery during the trial.
29. Known contraindications or allergies to glucose-dependent insulinotropic peptide (GIP) analogs or related compounds, or a past tendency to cause allergies.
Previous/Concomitant Treatment
30. Scheduled for chemotherapy regimens, including multiple administrations during CINV observation on days 2-5 of each cycle.
31. Scheduled for abdominal or pelvic radiation therapy on days -5 to 6 of chemotherapy.
32. Prior exposure to any systemic anticancer treatment, including various types of malignancies that have previously achieved remission. In exceptional circumstances, patients exposed to low-emetic anticancer regimens and who have not experienced CINV may be permitted to participate with the approval of the trial commissioner.
33. Medications, herbal formulas, or alternative treatments received prior to the start of chemotherapy that are known or may have antiemetic activity.
24 hours before chemotherapy:
• Dopamine receptor antagonists
• H1 antihistamines or antimuscarinic drugs
• Benzodiazepines
• Cannabinoids
• Atypical antipsychotics, and
• Herbal formulas.
72 hours before chemotherapy:
• Systemic corticosteroids (topical and inhaled corticosteroids are permitted, with a daily dose of ≤10 mg prednisone or equivalent)
• NK-1 receptor antagonists
• Serotonin (5-HT3) antagonists, and
• Alternative procedures, including acupuncture and acupressure.
34. Treatment with GIP or glucagon-like peptide-1 (GLP-1) receptor agonists within 4 weeks prior to chemotherapy. For short-acting drugs, a shortened window period may be permitted with the approval of the trial commissioner.
35. A course of drug therapy is required that, according to local drug instructions, may result in clinically significant drug interactions with 5-HT3 receptor antagonists, NK1 receptor antagonists, and dexamethasone.
Concurrent Clinical Trial Experience
36. Currently participating in any other clinical trial involving the experimental intervention, or any other type of medical research deemed medically or scientifically incompatible with this trial by the trial commissioner.
37. Participating in a clinical trial involving the experimental intervention within 30 days prior to C1D1. If the half-life of the previous experimental intervention was longer, it must be within 3 months or 5 half-lives prior to C1D1 (whichever is longer).
Other Exclusion Criteria
38. Currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 30 days after the last dose of the experimental intervention.
11. Metastasis to the Central Nervous System (CNS), except for asymptomatic brain or spinal metastases receiving specific treatment.
12. Known hypersensitivity or contraindication to 5-HT3 receptor antagonists, NK1 receptor antagonists, or dexamethasone.
13. Diagnosed with uncontrolled diabetes mellitus, defined as glycated hemoglobin (HbA1c) ≥ 8% or a history of severe hypoglycemia within the past 3 months.
Exception: Participants with medically controlled type 1 or 2 diabetes currently receiving insulin or other antihyperglycemic agents.
14. Current evidence suggests a clinically significant cardiac condition or a related history, which may increase the risk of participation in the trial or potentially confound electrocardiogram (ECG) data analysis.
15. Conditions related to QT/QTcF (corrected QT interval).
16. A known family or personal history of medullary thyroid carcinoma or type 2 multiple endocrine neoplasia syndrome.
17. Signs or symptoms of thyroid tumors, such as a neck mass, dysphagia, dyspnea, or persistent hoarseness (without other identifiable cause), or elevated serum calcitonin levels > 35 ng/L.
18. Thyroid-stimulating hormone (TSH) levels exceeding the normal range according to local laboratory standards.
Exception: Participants receiving treatment for hypothyroidism and having been on a stable dose for at least 6 months prior to screening.
19. At screening, an active hepatitis B test result is defined as a positive hepatitis B surface antigen (HBsAg) and/or a positive hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) result. Unless required by local regulations, participants without a history of HBV do not need to undergo HBV screening.
Exception: Participants who have been treated for HBV/have chronic HBV and are HBsAg positive, provided that:
• they received an approved course of suppressive antiviral therapy before Cycle 1 Day 1 (C1D1);
• they were on the same antiviral therapy throughout the trial; and
• HBV DNA was undetectable for ≤ 14 days before C1D1.
20. Infection with Hepatitis C virus (HCV), defined as a positive anti-HCV antibody test, with certain exceptions. Unless required by local guidelines, participants without a history of HCV do not need to undergo HCV screening.
21. Known infection with Human Immunodeficiency Virus (HIV) and untreated, with certain exceptions. Unless required by local guidelines, HIV screening is not required.
22. Known active CMV infection confirmed by cytomegalovirus (CMV) PCR testing.
23. Current or significant medical history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or nervous system conditions that may:
• significantly alter drug absorption, metabolism, or elimination;
• pose a risk during experimental treatment; or
• interfere with data interpretation. 24. A history of nausea and vomiting due to other non-malignant medical conditions, potentially leading to nausea, retching, or vomiting, or a history of anticipatory nausea and vomiting.
25. Hypercalcemia as defined by local laboratory standards.
26. A history of long-term alcohol abuse, intravenous drug abuse, or illicit drug abuse within the year prior to screening.
27. Scheduled for bone marrow transplantation or stem cell rescue therapy.
28. Scheduled for major surgery during the trial.
29. Known contraindications or allergies to glucose-dependent insulinotropic peptide (GIP) analogs or related compounds, or a past tendency to cause allergies.
Previous/Concomitant Treatment
30. Scheduled for chemotherapy regimens, including multiple administrations during CINV observation on days 2-5 of each cycle.
31. Scheduled for abdominal or pelvic radiation therapy on days -5 to 6 of chemotherapy.
32. Prior exposure to any systemic anticancer treatment, including various types of malignancies that have previously achieved remission. In exceptional circumstances, patients exposed to low-emetic anticancer regimens and who have not experienced CINV may be permitted to participate with the approval of the trial commissioner.
33. Medications, herbal formulas, or alternative treatments received prior to the start of chemotherapy that are known or may have antiemetic activity.
24 hours before chemotherapy:
• Dopamine receptor antagonists
• H1 antihistamines or antimuscarinic drugs
• Benzodiazepines
• Cannabinoids
• Atypical antipsychotics, and
• Herbal formulas.
72 hours before chemotherapy:
• Systemic corticosteroids (topical and inhaled corticosteroids are permitted, with a daily dose of ≤10 mg prednisone or equivalent)
• NK-1 receptor antagonists
• Serotonin (5-HT3) antagonists, and
• Alternative procedures, including acupuncture and acupressure.
34. Treatment with GIP or glucagon-like peptide-1 (GLP-1) receptor agonists within 4 weeks prior to chemotherapy. For short-acting drugs, a shortened window period may be permitted with the approval of the trial commissioner.
35. A course of drug therapy is required that, according to local drug instructions, may result in clinically significant drug interactions with 5-HT3 receptor antagonists, NK1 receptor antagonists, and dexamethasone.
Concurrent Clinical Trial Experience
36. Currently participating in any other clinical trial involving the experimental intervention, or any other type of medical research deemed medically or scientifically incompatible with this trial by the trial commissioner.
37. Participating in a clinical trial involving the experimental intervention within 30 days prior to C1D1. If the half-life of the previous experimental intervention was longer, it must be within 3 months or 5 half-lives prior to C1D1 (whichever is longer).
Other Exclusion Criteria
38. Currently pregnant, breastfeeding, or planning to become pregnant during the trial or within 30 days after the last dose of the experimental intervention.
The Estimated Number of Participants
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Taiwan
42 participants
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Global
220 participants
