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AzTrials

Small Cell Lung CancerPhase 2NCT05363280

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 study testing AL8326 40 mg, AL8326 60 mg and AL8326 80 mg--stopped in people with Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), run by Advenchen Pharmaceuticals, LLC. at 7 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AL8326 40 mg, AL8326 60 mg and AL8326 80 mg--stopped
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
7 sitesin 2 countries
Study dates
1 Nov 2022to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Shiying Sprinzl contact

805-530-1550

shiyings@advenchen.com

Judy Chen contact

805-530-1550

Judyc@advenchen.com

7 sites in 2 countries

United States5 sites, 3 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Clinical Research Manager, 205-934-6454, annaburton@uabmc.edu

    Aakash Desai, MD

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Completed

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Cancer Answer Line (Taussig), 216-444-7923

    Lukas Delasos, MD

    Recruiting

  • Siteman Cancer Center, Washington University

    St Louis, Missouri, 63130

    314-747-7222, Patient_Care_Coordination_Center@bjc.org

    800-600-3606

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Withdrawn

Other trials in United States

Spain2 sites, 2 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    clinical study coordicator, • +34932746000, pedrorocha@vhio.net

    Pedro Filipe Simoees Da Rocha, MD

    Recruiting

  • Hospital Universitario Ramón Y Cajal

    Madrid

    Cliical study coordinator, (+34) 91 3368831

    María Eugenia Olmedo García, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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

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 .

Read the detailed description

This study is designed for two steps: Phase 2 Optimal Biological Dose (OBD) finding and Phase 2 expansion cohort study after OBD determination.

The Phase 2 study aims to find optimal biological dose (OBD) initially. Patients will be randomized to 3 different dosing groups in OBD finding cohorts. Each cohort will enroll 6-12 SCLC patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage. This OBD finding cohort will also evaluate the pharmacokinetic profile of AL8326.

OBD patient enrollment of 40 mg (n=12) and 60 mg (N=12) have been completed, waiting data maturing, 80 mg (n=4) has been stopped due to high intolerability. 40mg and 60mg cohort group can be expanded to an additional 6-12 patients in each cohort with only sparse PK sampling requirement if OBD is not able to be determined in early 12 patients of each cohort. Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma (RCC) are added to this protocol as additional expansion cohorts.

Being tested
AL8326 40 mg, AL8326 60 mg, AL8326 80 mg--stopped
Keywords
Recurrent small cell lung caner, Advanced small cell lung cancer, Metastatic Small lung cancer, ≥2nd Line treatment, Non small cell lung cancer, Renal Cell Carcinoma
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AL8326 40 mgDrug

    Taken AL3826 at 40mg QD orally

  • AL8326 60 mgDrug

    Taken AL3826 at 60mg QD orally

  • AL8326 80 mg--stoppedDrug

    Taken AL3826 at 80 mg QD orally

Study groups in NCT05363280
Study groupRoleWhat they receive
OBD finding cohort at low dose--completedExperimentalSubject in low dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Receives: Drug: AL8326 40 mg
OBD finding cohort at middle dose--completedExperimentalSubject in middle dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Receives: Drug: AL8326 60 mg
OBD finding cohort at high dose--completedExperimentalSubject in high dose group will receive AL8326 orally in each cycle until intolerable toxicity or disease progression or withdrawal . 6-12 subjects are in this group. Efficacy, safety and PK will be evaluated and compared within 3 different dosing group to define the final OBD.
Receives: Drug: AL8326 80 mg--stopped
Non-Small Cell Lung(NSCLC)Experimental≥2nd line NSCLC patient in 40 mg dose
Receives: Drug: AL8326 40 mg
Renal Cell Carcinoma( RCC )Experimental≥2nd line RCC patient in 60 mg dose
Receives: Drug: AL8326 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimal biological dose ( OBD )

    Determine the Optimal biological dose ( OBD ) via evaluation of dose limiting toxicity (DLT) events to decide the dosing using in expanded cohort

    Measured: 12 months

  2. Objective Response Rates (ORR)

    Evaluate the efficacy among 3 different dosing groups

    Measured: 12 month

  3. ORR evaluation for NSCLC and RCC

    ORR evaluation for NSCLC and RCC

    Measured: 24 month

Secondary outcomes (4)

  1. Duration of response ( DOR)

    DOR for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup;

    Measured: 36 month

  2. Progression-Free Survival (PFS)

    PFS for SCLC OBD group plus expansion cohort, NSCLC and RCC cohortgroup

    Measured: 36 month

  3. Pharmacokinetic endpoints

    Pharmacokinetic endpoints Maximum Plasma Concentration ( Cmax)

    Measured: 24 month

  4. Pharmacokinetic endpoint Area Under the Curve (AUC)

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start1 Nov 2022
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The phase 2 study aims to find optimal biological dose (OBD) for Phase 2 expansion cohort clinical study. Patients will be randomized to a 3 different dosing daily AL8326 groups ( low. middle. high) in 1:1:1 ratio in OBD finding cohorts. ----OBD patient enrollment of 40 mg (n=12) and 60 mg (N=12) have been completed, waiting data maturing, 80 mg (n=4) has been stopped due to high intolerability. A phase 2 expansion cohort will enroll SCLC--on hold NSCLC -≥2nd line treatment with up to n=15 patients in 40 mg RCC-≥2nd line treatment with up to n=15 patients in 60 mg
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363280
Sponsor's protocol ID
AL8326-US-001
Status last verified
Apr 2026
First submitted
22 Apr 2022
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AL8326 40 mg, AL8326 60 mg and AL8326 80 mg--stopped in people with Small Cell Lung Cancer and Renal Cell Carcinoma (RCC), run by Advenchen Pharmaceuticals, LLC. at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiying Sprinzl (805-530-1550, shiyings@advenchen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimal biological dose ( OBD ) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363280.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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