Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC

NCT07547332 | Not Yet Recruiting Phase 2

• 1 other identifier: Lungmate-045
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-arm, investigator-initiated clinical study (IIT) designed to evaluate the efficacy and safety of nab-paclitaxel combined with local radiotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after first-line treatment. Small cell lung cancer (SCLC) is an aggressive type of lung cancer, and extensive-stage SCLC (ES-SCLC) refers to its advanced stage. For patients whose cancer progresses after first-line treatment, there are very limited effective second-line and later-line treatment options. Commonly used clinical regimens such as topotecan and lurbinectedin only provide modest improvements in tumor response and survival, and often cause severe hematological toxicities (represented by bone marrow suppression). This leaves patients in a persistent dilemma of "insufficient efficacy and limited tolerability", highlighting a clear unmet medical need for better treatment options in this population. Against this background, this study explores a comprehensive treatment strategy using nab-paclitaxel as the chemotherapy backbone, combined with local radiotherapy in eligible patients. Nab-paclitaxel is a nanoparticle albumin-bound form of paclitaxel, with a relatively controllable toxicity profile and manageable administration in clinical practice. Local radiotherapy may create a synergistic effect by improving the tumor immune microenvironment and enhancing local tumor control, with the goal of providing better evidence for a "chemotherapy ± local therapy" combination as a second-line treatment option.

Conditions

Small Cell Lung Cancer; Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Keywords

small cell lung cancer; sclc; extensive stage small cell lung cancer; es-sclc

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Defined as the time from the first dose to the first occurrence of disease progression (assessed by the investigator per RECIST v1.1) or death from any cause, whichever occurred first

  up to 30 months

Secondary Outcomes (3)

• Overall Survival (OS)

  up to 60 months

• Objective Response Rate (ORR)

  up to 30 months

• Duration of Response (DOR)

  up to 30 months

Study Arms (1)

Albumin-bound Paclitaxel Combined with Local Therapy

OTHER

The treatment period consisted of 6 cycles of albumin-bound paclitaxel at a dose of 260 mg/m² via IV infusion on a Q3W schedule. (Optional) Concurrent or sequential local therapy was administered until disease progression or unacceptable toxicities. Local therapy regimen: * Radiation timing: Radiotherapy could be administered concurrently or sequentially with albumin-bound paclitaxel, determined by the radiation oncologist based on the patient's performance status (PS), tumor burden/location, chemotherapy tolerance, bone marrow reserve (neutrophil/platelet counts), and risk of acute radiation toxicity (e.g., CNS, GI tract). * Radiation fields: Target fields must cover at least 1 pathologically/ radiologically confirmed progressive lesion, prioritizing: ① Intrapulmonary primary lesion + ipsilateral hilar/mediastinal lymph node metastases (if residual/progressive); ② Symptomatic metastases; ③ Lesions at risk of severe complications. Excessive irradiation to normal tissues was strictly p

Radiation: Albumin-bound Paclitaxel Combined with Local Therapy; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel

Interventions

Albumin-bound Paclitaxel Combined with Local Therapy RADIATION

The treatment period consisted of 6 cycles of albumin-bound paclitaxel at a dose of 260 mg/m² via IV infusion on a Q3W schedule. (Optional) Concurrent or sequential local therapy was administered until disease progression or unacceptable toxicities. Local therapy regimen: * Radiation timing: Radiotherapy could be administered concurrently or sequentially with albumin-bound paclitaxel, determined by the radiation oncologist based on the patient's performance status (PS), tumor burden/location, chemotherapy tolerance, bone marrow reserve (neutrophil/platelet counts), and risk of acute radiation toxicity (e.g., CNS, GI tract). * Radiation fields: Target fields must cover at least 1 pathologically/ radiologically confirmed progressive lesion, prioritizing: ① Intrapulmonary primary lesion + ipsilateral hilar/mediastinal lymph node metastases (if residual/progressive); ② Symptomatic metastases; ③ Lesions at risk of severe complications. Excessive irradiation to normal tissues was strictly pr

Albumin-bound Paclitaxel Combined with Local Therapy

Albumin-Bound Paclitaxel /nab-Paclitaxel DRUG

The treatment period consisted of 6 cycles of albumin-bound paclitaxel at a dose of 260 mg/m² via IV infusion on a Q3W schedule. (Optional) Concurrent or sequential local therapy was administered until disease progression or unacceptable toxicities.

Albumin-bound Paclitaxel Combined with Local Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Written informed consent has been signed. (2) Male or female, aged 18-75 years. (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• (4) Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the Veterans Administration Lung Group (VALG) staging system.
• (5) Patients with ES-SCLC who have received at least one prior line of systemic therapy.
• (6) Patients with previously treated asymptomatic central nervous system (CNS) metastases are eligible if all of the following criteria are met:
• Only supratentorial and cerebellar metastases (i.e., no metastases in the midbrain, pons, medulla oblongata, or spinal cord);
• No requirement for ongoing corticosteroid therapy for CNS disease;
• No stereotactic radiotherapy within 7 days prior to randomization;
• No disease progression observed on imaging from completion of CNS-directed therapy through screening;
• ⑤ If new asymptomatic CNS metastases are detected on screening imaging, patients must receive radiotherapy and/or resection of CNS lesions. After such treatment, these patients may be randomized without additional brain scans if all other eligibility criteria are satisfied.
• (7) Presence of measurable disease as defined by RECIST v1.1. A previously irradiated lesion may be considered measurable only if clear disease progression has occurred after radiotherapy and the lesion is not the only site of disease.
• (8) Adequate hematologic and end-organ function as defined by laboratory results obtained within 14 days prior to randomization:
• Absolute neutrophil count (ANC) ≥ 1500 cells/μL without granulocyte colony-stimulating factor support; lymphocyte count ≥ 500 cells/μL;
• Platelet count ≥ 100,000/μL without transfusion; hemoglobin ≥ 9.0 g/dL (may be achieved by transfusion); ③ International normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN). This criterion applies only to patients not receiving anticoagulation. Patients on anticoagulation must be on a stable dose; ④ Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 2.5 × ULN, except: Patients with confirmed liver metastases: AST and/or ALT ≤ 5 × ULN; Patients with confirmed liver or bone metastases: alkaline phosphatase ≤ 5 × ULN;
• Serum bilirubin ≤ 1.25 × ULN. For patients with known Gilbert's disease, serum bilirubin ≤ 3 × ULN is permitted;
• Serum creatinine ≤ 1.5 × ULN. (9) Patients must provide a pre-treatment tumor tissue sample during the study. Any available tumor tissue sample is acceptable. Submission may be completed after enrollment.

You may not qualify if:

• Patients meeting any of the following criteria are ineligible:
• Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during screening or on prior imaging.
• Spinal cord compression not radically treated with surgery and/or radiotherapy, or previously diagnosed spinal cord compression without clinical evidence of stable disease for at least 1 week prior to randomization.
• Leptomeningeal metastases. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently); indwelling catheters are not permitted.
• Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium, serum calcium \> 12 mg/dL, or corrected serum calcium \> ULN).
• History of malignancy other than SCLC within 5 years prior to randomization, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS \> 90%) and curative potential after treatment, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer with radical surgery, or ductal carcinoma in situ with radical surgery.
• Pregnant or lactating women, or women planning pregnancy during the study period.
• History of severe allergic, hypersensitivity, or anaphylactic reactions to chimeric, humanized, or human antibodies or fusion proteins.
• Known hypersensitivity to any component of biologic medicinal products produced in Chinese hamster ovary (CHO) cells or to the study drug formulation.
• History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, and glomerulonephritis.
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid hormone replacement therapy are eligible.
• Patients with type 1 diabetes mellitus controlled on a stable insulin regimen are eligible.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo only (patients with psoriatic arthritis are excluded) may be enrolled if:
• Rash involves \< 10% of body surface area; ② Disease is well controlled at baseline requiring only low-potency topical corticosteroids; ③ No acute exacerbation of underlying disease in the past 12 months (no requirement for PUVA, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high-potency or oral corticosteroids).
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, or active pneumonitis on screening chest CT scan.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

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)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Peng Zhang DR.

CONTACT

+8615221538837; zhangpeng1121@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician, Department of Thoracic Surgery

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 23, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 23, 2026

Record last verified: 2026-01