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A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC

ConditionNon Small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWayshine Biopharm, Inc.

About this trial

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥Age 18, gender is not limited;

Locally advanced or metastatic NSCLC confirmed by pathology;

Patients who have been genetically tested to carry EGFR sensitive mutations;

Blood/Tissue samples must be provided for testing;

Disqualifiers

Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.

Have previously received more than two EGFR-TKI inhibitors for part A;

Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.

Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Osimertinib (Tagrisso®)

    Drug

    Drug: Osimertinib Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: Osimertinib Given PO, 80mg, once daily

  • WSD0922-FU

    Drug

    Drug: WSD0922-FU Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: WSD0922-FU Given PO

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Dose escalation (WSD0922-FU and Osimertinib)Experimental treatment 2 interventions
Group B: Dose expansion (WSD0922-FU and Osimertinib)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC

Safety (incidence and severity of adverse events \[AE\])

Time frame
12 months
2

PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC

ORR

Time frame
every 6 weeks, up to 2 years

Secondary outcomes

1

To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer

Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs)

Time frame
12 months
2

Disease Control Rate (DCR)

the percentage of patients who have a best overall response of CR or PR or SD

Time frame
every 6 weeks, up to 24 months
3

Duration of Response (DoR)

proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression

Time frame
every 6 weeks, up to 24 months
4

PFS

proportion of patients with the time from randomization until the date of objective disease progression or death

Time frame
every 6 weeks, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wayshine Biopharm, Inc.

Lead sponsor

Source ClinicalTrials.gov
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