Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

NCT06496048 | Recruiting Phase 3 DMC

• 1 other identifier: LY01017/CT-CHN-302
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

Conditions

Relapsed Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS will be calculated calculated from the date of randomization until the date of death or the last contact date (in which case, OS time will be censored at that date)

  from the date of randomization until the date of death or the last contact date, up to 12 months after randomization of the last enrolled subject

Secondary Outcomes (4)

• Progression-free survival by IRC (Independent Review Committee)

  Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject

• Progression-free survival by IA (Investigator Assessment)

  Time Frame: From the date of randomization to the date of progressive disease, death or last tumor assessment or further anticancer treatment, up to 12 months after randomization of the last enrolled subject

• Overall response rate by IRC

  From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject

• Overall response rate by IA

  From the date of randomization to the date of death or the date of progressive disease, up to 12 months after randomization of the last enrolled subject

Other Outcomes (9)

• Overall survival rate at 12 month

  At 12 months

• Overall survival rate at 24 months

  At 24 months

• Progression-free survival rate at 6 months by IRC

  At 6 months

Study Arms (3)

Lurbinectedin monotherapy

EXPERIMENTAL

Drug: Lurbinectedin

Lurbinectedin + Irinotecan combined therapy

EXPERIMENTAL

Drug: Irinotecan; Drug: Lurbinectedin

Topotecan

ACTIVE COMPARATOR

Drug: Topotecan

Interventions

Lurbinectedin DRUG

Lurbinectedin 3.2 mg/m2 administered by infusion on Day 1 of each cycle (q3wk)

Also known as: PM01183

Lurbinectedin monotherapy

Irinotecan DRUG

Irinotecan 75 mg/m² intravenously Days 1 \& 8 q3wk

Lurbinectedin + Irinotecan combined therapy

Topotecan DRUG

Topotecan 1.2 mg/m² intravenously Days 1-5 q3wk

Topotecan

Eligibility Criteria

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

You may qualify if:

• Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.
• Men or women ≥18 years of age.
• Histologically or cytologically confirmed SCLC.
• Life expectancy ≥12 weeks.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).
• One prior line of etoposide + platinum chemotherapy with/without anti-PD-1 or anti-PD-L1 (Note: at least 70% of the patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)
• Chemotherapy-free interval (CTFI, i.e., the time from the last dose of first-line platinum-based chemotherapy to the occurrence of disease progression) ≥30 days.
• At least one measurable lesion (in accordance with RECIST 1.1 criteria).
• Adequate organ function as defined below:
• Hemoglobin ≥ 9.0 g/dL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 109/L, and platelet count ≥ 100 × 109/L.
• Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN.
• Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN.
• Albumin ≥ 3.0 g/dL.
• Calculated creatinine clearance (CrCL) ≥ 40 mL/min (using the Cockcroft-Gault formula, as detailed in Appendix IV).
• ≥ 3 weeks since the last anti-tumor therapy and recovery of adverse events (AEs) related to prior anti-tumor therapy to Grade ≤ 1, as judged by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) (Except for anemia; and recovery to Grade ≤ 2 for sensory neuropathy, asthenia and alopecia).

You may not qualify if:

• Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.
• Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).
• Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).
• Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).
• Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and/or therapeutic) at other sites within 2 weeks prior to randomization.
• Patients with limited-stage disease who plan to receive local or regional treatment (including PCI, thoracic radiotherapy, or both) during the study (Note: patients with extensive-stage disease may receive radiotherapy during the study if they meet the requirements as described in Section 5.8.1).
• Patients who, at the screening visit, are about to receive radiotherapy, such as for painful bone metastasis and/or risk of spinal cord compression. Patients who have a history of bone marrow and/or stem cell transplantation and allogeneic transplantation.
• Having received a live vaccine or attenuated live vaccine within 30 days before the first dose of the investigation medicinal product (inactivated vaccines are allowed).
• Concomitant diseases:
• Having unstable angina pectoris, myocardial infarction, congestive heart failure (CHF) of New York Heart Association (NYHA) class II or above, or clinically significant heart valve diseases within one year prior to screening.
• Having symptomatic arrhythmia, or arrhythmia with unstable control and requiring continuous treatment at screening.
• Patients requiring continuous oxygen inhalation within 2 weeks prior to randomization.
• Patients with confirmed or suspected diffuse interstitial lung disease or pulmonary fibrosis.
• Patients who have rapidly increasing pleural or pericardial effusion with significant symptoms, and/or need prompt local therapy within 7 days, at screening.
• Hepatic cirrhosis with the Child-Pugh score (see Appendix II for the scoring criteria) of B or C.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Jilin Provincial Tumor Hospital

Jilin, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

PM 01183; Irinotecan; Topotecan

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)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Ying Chen, Doctor

  Jilin Provincial Tumor Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunjiao Wu, Doctor

CONTACT

+86186431121295651; 2956519672@.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: September 14, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)