Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
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;
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Albumin-bound Paclitaxel Combined with Local Therapy
RadiationThe 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 /nab-Paclitaxel
DrugThe 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.
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: Albumin-bound Paclitaxel Combined with Local TherapyOther 2 interventions
Trial outcomes
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
Time frame
up to 30 monthsSecondary outcomes
1
Overall Survival (OS)
The time from the first dose to death from any cause.
Time frame
up to 60 months2
Objective Response Rate (ORR)
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator using RECIST v1.1.
Time frame
up to 30 months3
Duration of Response (DOR)
The time from the first documented objective response to disease progression (assessed by the investigator per RECIST v1.1) or death from any cause, whichever occurred first.
Time frame
up to 30 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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