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UNKNOWNPHASE2

Study of HA121-28 in Patients With Non-Small Cell Lung Cancer

A Single-Arm, Multi-Centre, Open-Label Phase II Study of HA121-28 in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer

NCT05117658•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy and safety of HA121-28 tablets in patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily participate in this study and sign the informed consent form;
•2. Aged 18 \~ 75 years old (inclusive), male or female;
•3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer;
•4. RET gene fusion, as demonstrated by "Next-generation" sequencing(NGS) method in central laboratory with College of American Pathologists(CAP) or Clinical Laboratory Improvement Amendments(CLIA) certification;
•5. Progressive disease after at least one line of standard therapy (including patients with disease progression during or within 6 months of the end of adjuvant therapy);
•6. At least one measurable lesion according to RECIST 1.1 (for lesions previously treated with radiation, the lesion can be included as a measurable lesion only if there is clear disease progression after radiotherapy);
•7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
•8. Adequate organ function, laboratory tests meeting the following criteria:
•* Neutrophil count (ANC) ≥ 1.5 × 10\^9/L (no G-CSF for WBC-elevating therapy within 2 weeks prior to the laboratory test);
•* Platelet count (PLT) ≥ 75 × 10\^9/L (no platelet transfusion or other drugs to promote platelet production within 2 weeks prior to the laboratory test);
+6 more criteria

Exclusion Criteria

•1. Had a documented oncogenic driver gene alteration other than RET in NSCLC, ie, activating EGFR, BRAF, or KRAS mutation, MET exon 14 skipping mutation or high-level amplification, and ALK, ROS1, or NTRK1/2/3 gene fusions;
•2. Prior treatment with selective RET inhibitors (including investigational selective RET inhibitors, such as LOXO-292, BLU-667, RXDX-105, etc.);
•3. Patients who previously received any anti-tumor therapy (including but not limited to chemotherapy, radiotherapy and targeted therapy, etc.) within 4 weeks before the first use of the study drug; traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 2 weeks; local palliative radiotherapy for the relief of bone metastasis pain within 2 weeks;
•4. Abnormal coagulation function (INR \> 1.5 or APTT \> 1.5 × ULN); patients with bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy;
•5. Urine routine showed urine protein ≥ + + and 24 h urine protein \> 1.0 g;
•6. Patients who have undergone major surgical procedures within 4 weeks before the first dose or are expected to undergo major surgery during the study;
•7. Patients with central nervous system (CNS) metastases who present with progressive neurological symptoms or require an increase in corticosteroid dose to control their CNS disease. If a patient requires treatment with corticosteroids for CNS disease, the dose must be stable for two weeks prior to the first dose;
•8. Presence of poorly controlled pericardial, pleural, or peritoneal effusion;
•9. Interstitial pneumonia requiring steroid therapy, drug-induced pneumonitis, radiation pneumonitis (except for stable radiation pneumonitis);
•10. Significant cardiovascular disease, such as heart failure greater than New York Heart Association (NYHA) Class 2, unstable angina, serious arrhythmia, myocardial infarction or stroke within 6 months prior to the first dose, poorly controlled hypertension (defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg on multiple measurements while on medication);
+13 more criteria

Locations (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, China

Key Dates

Start Date

February 18, 2022

Primary Completion Date

October 1, 2023

Completion Date

October 1, 2023

Last Updated

August 4, 2022

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

HA121-28 tablet

DRUG

Contacts

Ruihua Xu, Ph.D

CONTACT

86-20-87343468 xurh@sysucc.org.cn

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of HA121-28 in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements