An Exploratory Study of Lurbinectedin With Radiotherapy in Locally-advanced SCLC After First-line Therapy

NCT06501976 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NCC4493
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

This exploratory trial aims to determine if it is safe to use radiotherapy and lurbinectedin to treat locally-advanced SCLC after first-line therapy. This study will enroll patients with thoracic disease but no distant metastases after first line treatment failure. Lurbinectedin kills tumor cells by blocks transcription and damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Traditional chemotherapy and radiotherapy is a routine medical treatment for locally-advanced SCLC, but the combination is always toxic. This trial may help understand if treating patients with lurbinectedin and radiotherapy could cause less side effects.

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events of radio therapy with lurbinectedin

  ≥grade 4 treatment related adverse events within 30 days of final RT fraction; Any treatment related adverse events leading to dose delays or reductions of lurbinectedin; Any treatment related serious adverse events .

  30 days following treatment completion

Secondary Outcomes (2)

• Progression free survival (PFS)

  From protocol treatment initiation to disease progression or death, assessed up to 24 months

• Overall survival (OS)

  From treatment initiation to death, , assessed up to 24 months

Study Arms (1)

Experimental Treatment: Lurbinectedin combined with Thoracic Radiotherapy

EXPERIMENTAL

Patients receive 2 cycles of lurbinectedin 2.6 mg/m2 combined with thoracic radiotherapy followed by 2 cycles of lurbinectedin 2.6 mg/m2 alone. Patients receive lurbinectedin intravenously (IV) over 1 hour on day 1 of each cycle.

Drug: Lurbinectedin; Radiation: Radiation Therapy

Interventions

Lurbinectedin DRUG

2.6 mg/m2 , Given IV, every 21 days

Also known as: PM01183, Zepzelca

Experimental Treatment: Lurbinectedin combined with Thoracic Radiotherapy

Radiation Therapy RADIATION

Thoracic radiotherapy

Experimental Treatment: Lurbinectedin combined with Thoracic Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has fully understood this study, voluntarily signed a written informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;
• Age ≥ 18 years, Male/female participants;
• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2;
• With pathologically confirmed diagnosis of Limited Stage SCLC(LS-SCLC),with local progression (mainly thoracic progression) after first-line chemotherapy with or without immunotherapy, but without distant metastasis; (Currently immunotherapy + chemotherapy is not the standard treatment for LS-SCLC);
• Has sufficient bone marrow, liver, kidney, and metabolic function, i.e., the functional levels of organs meet the following requirements:
• Platelets (PLT) ≥ 100×10\^9/L;
• Hemoglobin (Hb) ≥ 90 g/L;
• Absolute neutrophil (ANC) ≥ 2.0×10\^9/L;
• Regardless of whether liver metastasis is present, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0× upper limit of normal (ULN);
• Alkaline phosphatase (ALP) ≤ 5×ULN;
• Total bilirubin (TBIL) ≤ 1.5×ULN, and direct bilirubin ≤ 1.0×ULN;
• Serum creatinine ≤ 1.5×ULN or creatinine clearance rate ≥ 30 mL/min (calculated using the Cockcroft-Gault formula);
• Creatine phosphokinase (CPK) ≤ 2.5×ULN;
• Albumin ≥ 3.0 g/dL.
• A female of childbearing potential (FCBP) must have a negative serum pregnancy test prior to study entry. Woman of childbearing potential (WOCBP) must use adequate contraception during the test drug treatment period and for 6 months after the final dose. Male patients (with partners of WOCBP) must use adequate contraception for the duration of study participation, and 4 months after completion of administration.

You may not qualify if:

• With concurrent brain metastasis, a history of spinal cord compression, or meningeal metastasis;
• With bone metastases;
• Patients with obstructive atelectasis, superior vena cava syndrome requiring surgical/ endoscopic/ interventional treatment; suspected or confirmed pulmonary embolism patients; those with uncontrollable large amounts of pleural effusion, ascites, or pericardial effusion;
• Patients known to be allergic to any component of the test drug;
• Pregnancy or breastfeeding or WOCBP who has a positive serum pregnancy test;
• Comorbidities Requirements:
• Has unstable angina, myocardial infarction, congestive heart failure (CHF) classified as New York Heart Association (NYHA) II or higher, or other clinically significant cardiovascular diseases currently or within the past year prior to screening;
• Patients with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;
• Patients with severe arrhythmias requiring medication;
• Patients with active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks prior to administration;
• Patients with evidence of bleeding tendencies or coagulation disorders;
• Patients with other significant diseases judged unsuitable for entry by the investigator.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Nan Bi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Bi, MD

CONTACT

+010 87787692; binan_email@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 15, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share