An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing (NCT07141771) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing
100 participantsStarted 2025-12-31
Plain-language summary
Small-cell lung cancer (SCLC) has a high degree of malignancy and extremely poor prognosis, slow progress in the treatment of ES-SCLC, and a more ideal posterior therapy needs to be explored. This is an I / II, phase umbrella study to explore afterline treatment options following progression of frontline platinum-containing therapy for small cell lung cancer.
This study includes 2 parts:
Part 1 will enroll patients with end of first-line platinum-containing therapy and progression interval of less than 180 days or more of second-line therapy (no first-line relapse time required).
Part 2 will enroll patients with end of first-line platinum-containing therapy greater than 180 days.
Based on the optimal selection of patients with recurrent broad-stage small cell lung cancer with different molecular and clinical characteristics, we further explored different treatment modes suitable for different populations through umbrella cohort studies.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.The patient has sufficient important organ functions during screening (requiring no blood transfusion, no use of hematopoietic stimulating factors or human albumin preparations within 14 days prior to screening), and the specific definition is as follows:
✓. liver function: serum total bilirubin (Total bilirubin, TBIL) 1.5 Upper Normal Value (Upper limit of normal value, ULN), Patients with liver metastasis or with proven Gilbert syndrome, TBIL≤3×ULN. For subjects without liver metastases, Alanine aminotransferase (Alanine aminotransferase, ALT) and aspartate aminotransferase (Aspartate transferase, AST) ≤2.5×ULN, Subjects with liver metastases, ALT or AST 5 ULN;
✓. Renal function: creatinine clearance calculated according to the Cockcroft-Gault method (Clearance of creatinine, CCr) 60 mL/min;
✓. Coagulation: activated partial thromboplastin time (Activated partial thromboplastin time, APTT) and the international standardized ratio (International normalized ratio, INR) 1.5 ULN (subjects receiving anticoagulation are within treatment range);
✓. cardiac function criteria: echocardiogram (Echocardiography, ECHO) showed a left ventricular ejection fraction (LVEF) greater than 50%.
✓
What they're measuring
1
ORR
Timeframe: each cycle is 21 or28 days,from the first use until the date of first documented progression or date of death from any cause or start new anti-tumor therapy or withdraw ICF or the study is over，whichever came first, assessed up to 24 months
Trial details
NCT IDNCT07141771
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. characteristics of transcription factor subtypes:
✓. (1) SCLC-A and N types belong to neuroendocrine types, and SCLC-P and-I are cells with non-neuroendocrine subtypes. SCLC-A and N had significantly higher expression of neuroendocrine markers (chromaffin A (CgA) and synaptic vesicle protein (Syn)), while SCLC-P and I highly expressed the neuroendocrine inhibitory gene RE1 silent transcription factor (REST).
Exclusion criteria
✕. Acute toxicity associated with prior anti-tumor therapy for 4 weeks prior to the first dose did not return to grade NCI CTCAE v5.0 1 or the baseline level specified by the entry criteria (excluding alopecia or fatigue).
✕. The following drugs or herbal supplements cannot be stopped within 3 weeks before and during the study: (1) strong inducers or inhibitors of CYP3A4; (2) drugs mainly metabolized by CYP3A4;
✕. The subject does not agree to secondary biopsy or cannot obtain enough tissue specimens for full exon sequencing, transcriptome sequencing, and multiple fluorescent immunohistochemical testing.
✕. Mean corrected QT interval (Corrected QT interval, QTc, Fridericia's correction) from 12-lead ECG (12-Electrocardiograph, ECG)\> 470 ms (3 repeats). Various clinically significant cardiac rhythm, conduction, and resting ECG morphology abnormalities, such as complete left bundle branch block, degree III conduction block, degree II conduction block, and PR interval\> 250 ms. Various factors that may increase the risk of QTc extension or arrhythmic events, such as cardiac failure, hypokalemia, congenital long QT syndrome, long QT syndrome in immediate family history or unexplained sudden death under 40 years of age, are using any medication with known QT interval extension.
✕. Acute or chronic active hepatitis B \[defined as hepatitis B surface antigen (HbsAg) and/or hepatitis B core antibody (HbcAb) positive and hepatitis B virus (HBV) DNA copy number ≥ 1 × 10\]3 copies per mL or ≥ 200 IU/mL.
✕. Acute or chronic active hepatitis C (HCV), or HCV antibody positive and HCV-RNA levels greater than the upper central reference limit.