Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdvenchen Pharmaceuticals, LLC.

About this trial

This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .

Eligibility criteria

Qualifiers

Male or female, 18 years of age or older

ECOG performance status of 0 or 1

Histologically or cytologically confirmed SCLC /NSCLC/RCC

Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1

Disqualifiers

Serious, non-healing wound, ulcer or bone fracture

Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment

Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels

Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease

Trial design

Treatments tested in this trial

  • AL8326 40 mg
  • AL8326 60 mg
  • AL8326 80 mg--stopped

Treatment groups

80 Participants
are divided into 5 treatment groups