Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC (NCT07547332) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC
84 participantsStarted 2026-04-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (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 no…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: up to 30 months
Trial details
NCT IDNCT07547332
SponsorShanghai Pulmonary Hospital, Shanghai, China