Trial Summary
What is the purpose of this trial?This trial tests the safety and effectiveness of AL8326, a medication taken by mouth, in patients with advanced small cell lung cancer who need additional treatment. The drug works by blocking proteins that help cancer cells grow.
Do I have to stop taking my current medications?The trial requires that you stop taking strong inhibitors or inducers of CYP3A4, CYP2C9, and CYP2C19 at least 14 days before enrolling and during the study, unless it's an emergency or life-threatening situation.
Is the drug AL8326 a promising treatment for small cell lung cancer?The information provided does not mention AL8326, so we cannot determine if it is a promising treatment for small cell lung cancer based on the given research articles.145710
What safety data is available for AL8326 in treating small cell lung cancer?The safety data for AL8326, also known as lurbinectedin, indicates that it has an acceptable and manageable safety profile at the approved dose of 3.2 mg/m2 every 3 weeks. This was observed in a phase II basket trial involving 105 adult patients with metastatic small cell lung cancer who had disease progression after platinum-based chemotherapy.1291112
What data supports the idea that AL8326 for Small Cell Lung Cancer (also known as: AL8326, AL8326) is an effective treatment?The available research does not provide specific data on AL8326 for Small Cell Lung Cancer. Instead, it discusses other treatments like amrubicin and irinotecan, which are used in combination with cisplatin for extensive-disease small cell lung cancer. These studies focus on comparing the effectiveness of these drugs, but there is no mention of AL8326 in the context of small cell lung cancer treatment.356810
Eligibility Criteria
This trial is for adults over 18 with small cell lung cancer (SCLC) who need second or later line treatment. They should have a life expectancy of at least 3 months, be able to perform daily activities with minimal assistance (ECOG status 0-1), and have measurable cancer lesions. Excluded are those with high bleeding risks, recent hemoptysis, unhealed wounds/fractures, major surgery within the past month, serious heart conditions, or using certain drugs affecting liver enzymes.Inclusion Criteria
My cancer is confirmed as small cell lung cancer through testing.
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
I do not have conditions that increase my risk of bleeding significantly.
I have a serious wound, ulcer, or bone fracture that isn't healing.
I do not have serious heart or blood vessel problems.
Treatment Details
The trial tests three different doses of AL8326 oral medication on patients with recurrent or advanced SCLC. AL8326 is a multi-targeted receptor Tyrosine Kinase Inhibitor (TKI). The goal is to find out how safe it is and how well it works in controlling the disease after first-line treatments haven't worked.
3Treatment groups
Experimental Treatment
Group I: OBD finding cohort at middle doseExperimental Treatment1 Intervention
Subject 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.
Group II: OBD finding cohort at low doseExperimental Treatment1 Intervention
Subject 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.
Group III: OBD finding cohort at high doseExperimental Treatment1 Intervention
Subject 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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
Siteman Cancer Center, Washington UniversitySaint Louis, MO
Northwestern UniversityEvanston, IL
University of Alabama at BirminghamBirmingham, AL
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Who is running the clinical trial?
Advenchen Pharmaceuticals, LLC.Lead Sponsor
References
Multicenter phase II trial of paclitaxel, cisplatin, and etoposide with concurrent radiation for limited-stage small-cell lung cancer. [2017]To investigate the feasibility, efficacy, and safety of adding paclitaxel to cisplatin/etoposide chemotherapy and concurrent thoracic radiotherapy (TRT) in treatment of limited-stage small-cell lung cancer (LD-SCLC).
Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer. [2020]This phase II study was conducted to evaluate the safety and efficacy of the combination of paclitaxel and topotecan for patients with extensive stage small-cell lung cancer (ED-SCLC).
Small cell lung cancer and targeted therapies. [2007]Small cell lung cancer is a chemosensitive malignancy, yet long-term survival remains elusive for the majority of patients. Here, we report on progress in evaluating novel targeted therapies for the treatment of this disease.
Evaluation of the recommended dose and efficacy of amrubicin as second- and third-line chemotherapy for small cell lung cancer. [2012]This study was conducted to evaluate the recommended dose and activity of amrubicin (AMR) as second- or third-line chemotherapy for small-cell lung cancer (SCLC).
[Combined modality therapy for small cell lung cancer patient with limited stage disease]. [2008]To investigate the efficacy of combined modality therapy for small cell lung cancer (SCLC) patient with limited stage disease (LD).
Treatment of limited small cell lung cancer: an old or new challenge? [2011]This review highlights how progress has been made in treating limited small cell lung cancer and outlines current challenges to overcome for improved cure rates.
Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062. [2013]The EORTC 08062 phase II randomised trial investigated the activity and safety of single agent amrubicin, cisplatin combined with amrubicin, and cisplatin combined with etoposide as first line treatment in extensive disease (ED) small cell lung cancer (SCLC).
Phase III study comparing amrubicin plus cisplatin with irinotecan plus cisplatin in the treatment of extensive-disease small-cell lung cancer: JCOG 0509. [2022]This randomized phase III trial was conducted to confirm noninferiority of amrubicin plus cisplatin (AP) compared with irinotecan plus cisplatin (IP) in terms of overall survival (OS) in chemotherapy-naive patients with extensive-disease (ED) small-cell lung cancer (SCLC).
Safety of topotecan monotherapy for relapsed small cell lung cancer patients with pre-existing interstitial lung disease. [2015]To investigate the safety of intravenous topotecan monotherapy for relapsed small cell lung cancer (SCLC) patients with pre-existing interstitial lung disease (ILD).
Randomized phase 2 study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401). [2021]A cisplatin plus irinotecan (CPT-11) regimen is used for patients with extensive disease small cell lung cancer (ED-SCLC). Amrubicin (AMR) is primarily used for relapsed SCLC. The HOT1401/NJLCG1401 trial, an open-label randomized phase II trial, was designed to assess the benefit of maintenance therapy in patients with ED-SCLC who responded to induction therapy.
Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. [2022]Extensive-stage small-cell lung cancer (ES-SCLC) is associated with poor prognosis and treatment options are scarce. Immunotherapy has shown robust clinical activity in ES-SCLC in previous phase 3 trials. We aimed to assess the efficacy and safety of adebrelimab (SHR-1316), a novel anti-PD-L1 antibody, with standard chemotherapy as a first-line treatment for ES-SCLC.
Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. [2023]Label="BACKGROUND">Lurbinectedin was approved by FDA and other health regulatory agencies for treating adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Safety profile at approved dose (3.2 mg/m2 every 3 weeks) was acceptable and manageable in 105 adult SCLC patients from a phase II basket trial. This study analyses safety data from several solid tumours treated at the lurbinectedin-approved dose.