RightFit
RecruitingPhase 2

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

A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests how safe AL8326 pills are and how well they work. It is for adults with small cell or non-small cell lung cancer, or renal cell cancer (a type of kidney cancer), that has come back, is advanced, or has spread. They have had their first standard treatment and need more treatment.

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 .

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able to do all usual activities, or limited only in hard physical activities (ECOG score 0 or 1).
  • Small cell lung cancer, non-small cell lung cancer, or renal cell cancer confirmed by a tissue or cell test.
  • At least one cancer area that can be measured using the study's rules.
  • Expected to live at least 3 months.

Who can't join

  • A serious wound, open sore, or broken bone that is not healing.
  • Major surgery within 28 days, or minor surgery within 7 days, before treatment.
  • Active bleeding or a high risk of bleeding, such as a blood-clotting problem or a tumor involving major blood vessels.
  • Serious heart or blood vessel disease. This includes uncontrolled high blood pressure; a heart attack or unstable chest pain within 6 months; heart failure rated class II or higher; a serious uneven heartbeat needing medicine; or blood vessel disease outside the heart rated grade II or higher.
  • Coughing up blood within 3 months before joining.
  • Use of medicines that strongly change how certain liver enzymes (CYP3A4, CYP2C9, or CYP2C19) work within 14 days before joining or during the study, unless needed for an emergency or life-threatening condition.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Major Inclusion Criteria: 1. Male or female, 18 years of age or older 2. ECOG performance status of 0 or 1 3. Histologically or cytologically confirmed SCLC /NSCLC/RCC 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1 5. Have a life expectancy of at least 3 months Major Exclusion Criteria: 1. Serious, non-healing wound, ulcer or bone fracture 2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment 3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels 4. 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 5. Hemoptysis within 3 months prior to enrollment 6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it. More information available upon request

Study sites (5)

AL

FL

IL

MO

OH