(R)-6-((3,3-DIFLUORO-1-METHYLPIPERIDIN-4-YL)OXY)-N-(3-ETHYNYL-2-FLUOROPHENYL)-7-METHOXYQUINAZOLIN-4-AMINE-FUMARATE (2:1) for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.\n- 10. Females should be using adequate contraceptive measures.\n- 11. Male patients should be willing to use barrier contraception i.e., condoms.\n- 12. Patient must be stable on no more than 2 mg of dexamethasone.\n- 2. Male or female aged ≥18 years old.\n- 3. Histological or cytological confirmation diagnosis of NSCLC.\n- 4. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.\n- 5. Evidence of radiological disease progression.\n- 6. Documented EGFR mutation\n- 7. Patients must have confirmation of C797S mutation positive status.\n- 8.Eastern Cooperative Oncology Group (ECOG) 0-1.\n- 9. At least one lesion, not previously irradiated and not chosen for biopsy during the study."}

Exclusion criteria

• {"criterion_text":"- 1 Treatment with more than 2 prior lines of treatment for advanced NSCLC.Treatment with Osimertinib within 8 days of the first dose of study treatment.\n- 10. History of hypersensitivity of WSD0922-FU.\n- 11. Males and females of reproductive potential who are not using an effective method of birth control.\n- 12. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n- 13. Known intracranial hemorrhage which is unrelated to tumor.\n- 14. Seizures requiring a change.\n- 15. Patient must not take enzyme-inducing anticonvulsants treatment.\n- 2. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.\n- 3. Symptomatic brain complications that require urgent neurosurgical or medical intervention.\n- 4. Leptomeningeal metastasis.\n- 5.Any evidence of severe or uncontrolled systemic diseases.\n- 6.Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.\n- 7. Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 480 msec, obtained from electrocardiograms (ECGs); Any clinically important abnormalities in rhythm; Any factors that increase the risk of QTc prolongation.\n- 8. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n- 9.Inadequate bone marrow reserve or organ function as demonstrated."}

Primary endpoints

• {"endpoint_text":"- To determine the recommended phase 2 dose [RP2D] and Objective Response Rate (ORR).","definition_or_measurement_approach":"Objective Response Rate (ORR) assessed by RECIST v1.1; determination of RP2D (recommended Phase 2 dose)."}

Secondary endpoints

• {"endpoint_text":"- 1. To further assess the efficacy of WSD0922-FU in terms of: - Progression Free Survival (PFS) - Duration of Response (DoR) - Disease Control Rate (DCR) - Change in Tumor Size - Overall Survival (OS)","definition_or_measurement_approach":"Efficacy measured using standard oncology endpoints: PFS, DoR, DCR, change in tumor size and OS (no further measurement detail provided in the record)."}

France

Earliest CTIS Part Ii Submission Date

16-06-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

154

Number Of Sites

5

Number Of Participants

10

Primary sponsor

Full Name

Wayshine Biopharm Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaron (Chengdu) Clinical Services Co. Ltd.

Responsibilities

PK testing

Name

Syneos Health Inc.

Responsibilities

codes 1,11,12,13,5,8

Name

Syneos Health IVH UK Limited

Responsibilities

codes 1,11,12,13,5,8

Name

Bioclinica Inc.

Responsibilities

Independent review committee (IRC)

Third parties

• {"country":"China","full_name":"Pharmaron (Chengdu) Clinical Services Co. Ltd.","duties_or_roles":"PK testing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Samples logistics","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Burning Rock Dx LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Guangdong Janus Medical Technology Co. Ltd.","duties_or_roles":"codes 10,3,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Independent review committee (IRC)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"Syneos Health IVH UK Limited","duties_or_roles":"codes 1,11,12,13,5,8","organisation_type":"Pharmaceutical company"}