A Phase Ib / IIA Study of AL8326 in Small Cell Lung Cancer

  • STATUS
    Recruiting
  • days left to enroll
    66
  • participants needed
    237
  • sponsor
    Advenchen Laboratories Nanjing Ltd.
Updated on 28 May 2021
Investigator
yingyin Li
Primary Contact
The affiliated hospital of Xuzhou medical university (0.0 mi away) Contact
+8 other location
etoposide
international normalized ratio
neutrophil count
carboplatin
gemcitabine
irinotecan
cancer chemotherapy
alopecia
vinorelbine
ifosfamide
topotecan

Summary

Based on indicators such as 24 week progression free survival (24 weeks PFS) in small cell lung cancer (SCLC) patients without disease progression after first-line platinum containing chemotherapy, objective response rate (ORR) in SCLC patients with recurrence or progression after first-line platinum containing chemotherapy, and orr in SCLC patients with recurrence or progression after second-line and above treatment,Evaluation of the effectiveness of al8326 monotherapy in small cell lung cancer.

Description

This trial is a multicenter, single arm, open label, nonrandomized, phase Ib / IIA trial that will evaluate the preliminary efficacy and safety of AL8326 in patients with small cell lung cancer (SCLC).Three treatment groups were used in this trial, and the study population, sample size, and basic design of each group were as follows:

Group A: Patients with small-cell lung cancer without disease progression (in remission [PR or Cr] or stable disease [SD] status) after first-line platinum containing chemotherapy were included, with a total sample size expected to be 79 patients.

Group B: Patients who relapsed or progressed after first-line platinum containing chemotherapy regimens, with a total sample size expected to be 79 patients.

Group C: Patients with small cell lung cancer who have relapsed or progressed after at least one line of treatment (including first-line platinum containing therapy, second-line single agent or other) with a total sample size expected to be 79 patients.

Details
Condition Small Cell Lung Cancer, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment AL8326 tablets
Clinical Study IdentifierNCT04890795
SponsorAdvenchen Laboratories Nanjing Ltd.
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

All subjects or legal surrogates were required to give written, ethics committee approved informed consent prior to initiation of any screening procedures
Age 18 years, both genders, patients with histologically confirmed SCLC, and fulfilling the following criteria
Group A: Patients with small-cell lung cancer without disease progression (in
remission [PR or Cr] or stable disease [SD] status according to RECIST 1.1
criteria) after first-line platinum containing chemotherapy, including
extensive stage and limited stage who were not eligible for radical
radiotherapy, received four to six cycles of platinum containing chemotherapy
previously; Group B: Patients with small-cell lung cancer who have relapsed or
progressed after first-line platinum containing chemotherapy regimens; Group
C: Patients with small cell lung cancer who have relapsed or progressed after
at least one line of therapy (including first-line platinum containing
therapy, second-line single agent therapy, or other);Notes: platinum
containing chemotherapy regimens included etoposide + cisplatin, etoposide +
carboplatin, irinotecan + cisplatin, irinotecan + carboplatin, etoposide +
lobaplatin;Second line monotherapy regimens include topotecan, irinotecan
paclitaxel, docetaxel, gemcitabine, oral etoposide, vinorelbine, temozolomide
ifosfamide;Second line and beyond other treatments include small molecule
targeted agents, monoclonal antibodies, etc
\. ECOG (PS) score was 0,1
\. Life expectancy 12 weeks
\. Subjects in arm B / C had at least one measurable tumor lesion according
to response evaluation criteria in solid tumors (RECIST 1.1
\. The subject had adequate organ and bone marrow function meeting the
following laboratory test criteria
Bone marrow function: absolute neutrophil count (ANC) 1.510^9 / L (1500 / mm^3), platelets 8010^9/L
Hemoglobin 9.0 g / dl;Liver function: serum total bilirubin 1.5 times the upper limit of normal (ULN), with the exception of patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that manifests as elevated unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology)
Those without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5ULN, those with liver metastases, ALT and AST 5ULN
Renal function: serum creatinine 1.5ULN and a standard endogenous creatinine clearance 60 ml / min estimated by the Cockcroft Gault formula, CCR (ml / min)
[(140 - age)Weight (kg)] / [72 SCR (mg / dl)], females as calculated0.85
Coagulopathy: international normalized ratio (INR) 1.5
Hemodynamically stable and left ventricular ejection fraction (LVEF) 50% as determined by echocardiography
Previous treatment with cytotoxic chemotherapy, traditional Chinese medicine, ending at least 4 weeks apart from first dose, receipt of nitroso or mitomycin at least 6 weeks apart, and TKI class molecularly targeted agents at least 4 weeks apart and having recovered to grade 1 from the toxic effects of previous chemotherapy, with the following exceptions: a.alopecia;b. Long term toxicity caused by radiotherapy, which could not be recovered after the judgment of the investigator;c. Platinum induced grade 2 and the following neurotoxicity such as hearing impairment (according to common terminology criteria for adverse events CTCAE V5.0)
Women of childbearing age and all male subjects must agree to use highly effective methods of contraception (condoms, contraceptive sponges, contraceptive gels, contraceptive membranes, IUDs, oral or injectable contraceptives, subcutaneous implants, etc.) for the duration of the study and for 3 months after discontinuation

Exclusion Criteria

Patients who had used AL8326 tablets in the past
Allergic to AL8326 or its analogues, or to any component in the prescription of AL8326
The patients with leptomeningeal history or leptomeningeal metastasis or central nervous system (CNS) metastasis at the time of screening had uncontrollable brain metastasis, spinal cord compression and cancerous meningitis within 8 weeks after the first medication, Patients with CNS metastasis or spinal cord compression whose clinical status is stable and does not need corticosteroid treatment and whose screening time is more than 4 weeks before treatment (including radiotherapy or surgery) are excluded
Patients with current or previous second tumor (except for fully treated basal cell carcinoma of skin or squamous cell carcinoma, cervical carcinoma in situ), unless radical treatment has been carried out and there is no evidence of recurrence and metastasis in the past 5 years
Those who have obvious gastrointestinal history or current diseases, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases that are difficult to control in recent 3 months, inability to swallow drugs or may affect the intake, transportation or absorption of drugs, or who have undergone total gastrectomy before
Patients with other important primary diseases, such as single drug uncontrolled hypertension (systolic blood pressure 160 mmHg and / or diastolic blood pressure 100 mmHg), arrhythmias that need clinical intervention (such as long QT syndrome, unmeasurable bazetts corrected QTc or male > 450 ms, female > 470 MS), abnormally prolonged arrhythmias caused by unstable coronary artery disease Patients with decompensated congestive heart failure (NYHA grade III or IV) or myocardial infarction, grade 2 or above thyroid disease, ascites or uncontrolled pleural effusion (CTCAE 5.0 2), history of thrombosis or stroke, autoimmune disease, and mental illness within 6 months before administration of the test drug
The patients with arteriovenous thrombotic events such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism in the first 6 months were screened
The tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade the important blood vessels during the follow-up study and cause fatal massive hemorrhage
Uncontrolled infection (within 2 weeks before the administration of the test drug)
Urine routine examination showed that urine protein was + +, and 24-hour urine protein was more than 1.0 G
The patients with grade 1 or more bleeding events (according to CTCAE 5.0 > grade 1), including gastrointestinal tract, respiratory system, tumor, urinary tract and cerebral hemorrhage, were screened
Patients treated with anticoagulants or vitamin K antagonists (such as warfarin, heparin or their analogues); Under the premise of prothrombin time international normalized ratio (INR) 1.5, it is allowed to use low-dose anticoagulants for preventive purposes, such as warfarin (not more than 1 mg daily, oral), low-dose heparin (not more than 12000 u daily) or low-dose aspirin (not more than 100 mg daily)
Hepatitis C virus (HCV) antibody, Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody test results of any one or more positive, or active hepatitis B patients (defined as HBV DNA 2000 IU / ml or HBV DNA 104 copies)
Patients who received any trial drug treatment within 30 days before signing the informed consent form
Patients who received red blood cell or platelet transfusion within 14 days before the first administration
Received major surgical treatment within 4 weeks before signing the informed consent (the patient must fully recover and stabilize before the start of treatment)
Patients with previous organ transplantation history or preparing for organ transplantation
Pregnant or lactating female patients
According to the judgment of the investigator, there are other reasons that are not suitable to participate in this study
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