Nonsmall Cell Lung Cancer Clinical Trial
Official title:
A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HS-10365 as First-Line Treatment for Patients With Locally Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.
This is an open-label, single arm, multi-center Phase 2 study in participants with treatment-naïve locally advanced or metastatic RET fusion-positive non-small cell lung cancer, which is designed to investigate the anti-tumor activity, safety and pharmacokinetics (PK) of HS-10365 at the recommended phase 2 dose (RP2D). HS-10365 will be administered orally twice daily until the occurrence of disease progression, unacceptable adverse events, withdrawal of consent, death or the end of the study. Primary endpoint is objective response rate (ORR) by Independent Reading Committee (IRC). Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and PK in the study population. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01312337 -
Iressa for EGFR Mutation Negative Non-small Cell Lung Cancer (NSCLC)
|
Phase 2 | |
| Completed |
NCT05860582 -
A Study of [14C]GB491 in Male Healthy Subjects
|
Phase 1 | |
| Terminated |
NCT02669914 -
MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors
|
Phase 2 | |
| Completed |
NCT02562027 -
SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer
|
N/A | |
| Recruiting |
NCT05358249 -
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02954523 -
Dasatinib and Osimertinib (AZD9291) in Advanced Non-Small Cell Lung Cancer With EGFR Mutations
|
Phase 1/Phase 2 | |
| Terminated |
NCT03998189 -
Metabolic and Microbial Profiling of Lung Cancer
|
N/A | |
| Not yet recruiting |
NCT03258671 -
IMRT and Timing in Combination With EGFRTKI for Stage IV Non-small-cell Lung Cancer
|
N/A | |
| Recruiting |
NCT03838588 -
The Tracking Molecular Evolution for NSCLC (T-MENC) Study
|
||
| Active, not recruiting |
NCT04984811 -
NT-I7 in Combination With Atezolizumab in Previously Untreated, PD-L1-expressing, Locally Advanced or Metastatic NSCLC
|
Phase 2 | |
| Recruiting |
NCT05688280 -
Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With CRC, NSCLC, and STS
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02951611 -
Effects of Acupuncture Stimulation on Systemic Inflammation
|
N/A | |
| Recruiting |
NCT02974933 -
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02980536 -
cSMART Liquid Biopsy and Dynamic Monitor of NSCLC Patients in Inner-Mongolia China
|
||
| Completed |
NCT02972216 -
Post-marketing Surveillance Study of Docetaxel-Based Chemotherapy
|
Phase 4 | |
| Recruiting |
NCT02905591 -
A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC
|
Phase 2 | |
| Recruiting |
NCT05873439 -
Genomically Guided Radiation Dose Personalization in Locally Advanced NSCLC
|
Early Phase 1 | |
| Active, not recruiting |
NCT02981108 -
A Study to Evaluate Safety, PK and Efficacy of HS-10296 in Patients With NSCLC
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02299141 -
Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT04900935 -
Patient-centered, Optimal Integration of Survivorship and Palliative Care
|
N/A |