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Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC

NCT07547332 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

RADIATION

Albumin-bound Paclitaxel Combined with Local Therapy

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

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

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.

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2028-01-01
Completion
2030-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07547332 on ClinicalTrials.gov