Metronomic Oral Paclitaxel Plus PD-1/ PD-L1 Inhibitor Maintenance in Advanced Lung Cancer (PULSE Study) (PULSE)
sunnuntai 2. elokuuta 2026 päivittänyt: Yue-Yin Pan, Anhui Provincial Cancer Hospital
Efficacy and Safety of Metronomic Oral Paclitaxel Plus an Immune Checkpoint Inhibitor as Maintenance Therapy After First-Line Induction in Advanced Squamous Non-Small Cell Lung Cancer and Extensive-Stage Small Cell Lung Cancer: A Multicenter, Multi-Cohort Exploratory Study
This study will evaluate the efficacy and safety of metronomic oral paclitaxel combined with a PD-1 or PD-L1 inhibitor as maintenance therapy in patients with advanced lung cancer whose disease has not progressed after first-line chemoimmunotherapy.
The study will include two independently analyzed cohorts. Cohort A will include patients with advanced squamous non-small cell lung cancer(sqNSCLC), and Cohort B will include patients with extensive-stage small cell lung cancer(ES-SCLC). All participants will receive oral paclitaxel three times weekly together with the same immune checkpoint inhibitor used during first-line induction therapy, whenever feasible.
The primary outcome is progression-free survival. Other outcomes include tumor response, overall survival, adverse events, treatment tolerability, and quality of life. Approximately 107 participants will be enrolled across multiple study centers.
Tutkimuksen yleiskatsaus
Tila
Tila
Rekrytointi
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
Immune checkpoint inhibitor-based chemoimmunotherapy is a standard first-line treatment for advanced squamous non-small cell lung cancer and extensive-stage small cell lung cancer. However, many patients experience disease progression shortly after completing the chemotherapy component and entering the maintenance phase. More effective and tolerable maintenance strategies are therefore needed.
Metronomic chemotherapy uses relatively low doses of cytotoxic treatment administered repeatedly over time. In addition to direct antitumor activity, metronomic paclitaxel may modulate the tumor immune microenvironment and enhance the effects of immune checkpoint inhibition. An oral paclitaxel formulation may also be more suitable for long-term maintenance treatment than intravenous paclitaxel because it avoids repeated intravenous infusions.
This is a prospective, open-label, multicenter, nonrandomized, multi-cohort exploratory study. Participants must have completed four cycles of standard first-line chemoimmunotherapy and achieved complete response, partial response, or stable disease without disease progression.
Cohort A will enroll approximately 67 participants with advanced squamous non-small cell lung cancer(sqNSCLC). Cohort B will enroll approximately 40 participants with extensive-stage small cell lung cancer(ES-SCLC). Both cohorts will receive oral paclitaxel solution at 100 mg/m² per dose, administered orally three times weekly, together with a PD-1 or PD-L1 inhibitor administered every 3 weeks according to the approved or guideline-recommended regimen. The maintenance immune checkpoint inhibitor should generally remain the same as that used during induction therapy.
Treatment will continue until radiographic disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. Tumor assessments will generally be performed every 6 weeks, and safety assessments will generally be performed every 3 weeks.
The primary endpoint is progression-free survival measured from the first dose of oral paclitaxel. The two cohorts will be analyzed independently, and no formal efficacy comparison between the two cohorts is planned. Exploratory analyses will evaluate circulating tumor DNA, peripheral immune-cell subsets, inflammatory and immune-related factors, and PD-1/PD-L1-related biomarkers.
Opintotyyppi
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
107
Vaihe
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Tian Tian, MD, PhD
- Puhelinnumero: +86-0551-65327751
- Sähköposti: drtiantian@ustc.edu.cn
Tutki yhteystietojen varmuuskopiointi
- Nimi: Yueyin Pan, MD, PhD
- Puhelinnumero: +86-0551-65327751
- Sähköposti: panyueyin@ustc.edu.cn
Opiskelupaikat
-
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Anhui
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Hefei, Anhui, Kiina, 230031
- Rekrytointi
- Anhui Cancer Hospital
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Ottaa yhteyttä:
- Yueyin Pan, MD; PhD
- Puhelinnumero: 0551-65327751
- Sähköposti: panyueyin@ustc.edu.cn
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Inclusion Criteria:
- 1. The participant has been fully informed about the study, voluntarily agrees to participate, provides written informed consent, and is willing to comply with long-term follow-up and study medication management.
- 2. Age 18 to 75 years, inclusive.
- 3. The participant meets the disease-specific requirements for either Cohort A or Cohort B: - Cohort A: Histologically and/or cytologically confirmed squamous non-small cell lung cancer(sqNSCLC), clinical stage IIIB to IV, unresectable and not suitable for definitive chemoradiotherapy, without actionable driver-gene alterations, and treatment-naive before initiation of first-line induction therapy. - Cohort B: Histologically and/or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC), defined according to the eighth edition of the American Joint Committee on Cancer staging system as stage IV disease, including any T, any N, and M1a, M1b, or M1c disease, or T3 to T4 disease due to multiple pulmonary nodules or disease that is too extensive or bulky to be included within a tolerable definitive radiotherapy field.
- 4. The participant has completed the required first-line induction regimen: - Cohort A: Completion of four cycles of a PD-1 or PD-L1 inhibitor plus cisplatin or carboplatin and paclitaxel or nab-paclitaxel, with a best induction response of complete response (CR), partial response (PR), or stable disease (SD) and no evidence of disease progression. - Cohort B: Completion of four cycles of a PD-1 or PD-L1 inhibitor plus cisplatin or carboplatin and etoposide, with a best induction response of CR, PR, or SD and no evidence of disease progression.
- 5. The last dose of first-line induction treatment was administered no more than 28 days before the first study treatment.
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 7. Estimated life expectancy of at least 3 months.
- 8. Adequate bone marrow and organ function, including: - Absolute neutrophil count (ANC) of at least 1.5 × 10⁹/L, platelet count of at least 100 × 10⁹/L, and hemoglobin of at least 90 g/L, without blood transfusion, growth-factor support, or erythropoietin within 14 days before assessment. - International normalized ratio (INR) and/or prothrombin time (PT) no greater than 1.5 times the upper limit of normal (ULN), and activated partial thromboplastin time (APTT) no greater than 1.5 times ULN. Participants receiving anticoagulation are eligible if coagulation parameters are within the expected therapeutic range.- Total serum bilirubin no greater than 1.5 times ULN; for participants with Gilbert syndrome, total bilirubin no greater than 3 times ULN. - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 2.5 times ULN, or no greater than 5 times ULN in participants with documented liver metastases.- Serum creatinine no greater than 1.5 times ULN and creatinine clearance of at least 60 mL/min for participants who received cisplatin or greater than 45 mL/min for participants who received carboplatin, calculated using the Cockcroft-Gault formula. - Serum amylase and/or lipase no greater than 1.5 times ULN.
- 9. At least one measurable lesion according to RECIST v1.1 before initiation of first-line induction therapy. Participants who achieve a CR and have no measurable lesion at maintenance-study entry remain eligible for progression-free survival (PFS) follow-up.
- 10. Participants with central nervous system (CNS) metastases may be enrolled if previous CNS metastases have received local treatment with surgery and/or radiotherapy at least 2 weeks before enrollment, neurological symptoms are absent or stable, and treatment-related adverse events have recovered to grade 1 or lower. Participants should not require ongoing antiepileptic treatment. If corticosteroids are clinically required, the dose must be stable and no greater than 10 mg/day prednisone or equivalent.
- 11. Participants of reproductive potential must agree to use an effective method of contraception during the study and for at least 3 months after the last study treatment. Women of childbearing potential must have a negative serum or urine pregnancy test before enrollment.
Exclusion Criteria:
- 1. Known hypersensitivity to oral paclitaxel, an immune checkpoint inhibitor, or any component of the study drugs.
- 2. Requirement for long-term treatment with a strong P-glycoprotein inhibitor that cannot be discontinued during the study.
- 3. A gastrointestinal disorder within 6 months before the first study treatment that may substantially interfere with oral drug absorption, including complete intestinal obstruction. Previous gastrectomy alone is not an exclusion criterion.
- 4. Active autoimmune disease or a history of autoimmune disease, including but not limited to interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, or nephritis. Participants with vitiligo, well-controlled type 1 diabetes mellitus, or hypothyroidism requiring only hormone-replacement therapy may be enrolled.
- 5. Any of the following during previous immune checkpoint inhibitor (ICI) treatment: - Immune-related pneumonitis, immune-related myocarditis, or immune-related neurological toxicity of any grade. - Other grade 3 or higher immune-related adverse events (irAE) that have not recovered to grade 1 or lower or to baseline. - Grade 3 or higher irAE during first-line induction that have not recovered to grade 1 or lower or to baseline. - Permanent discontinuation of the ICI because of immune-related toxicity.
- 6. Major surgery within 28 days before the first study treatment without adequate recovery, or planned major surgery during the study.
- 7. Active hepatitis, active tuberculosis, or another serious infection requiring systemic treatment, including active hepatitis C virus (HCV) infection, except for participants who are HCV antibody-positive but RNA-negative; active hepatitis B virus (HBV) infection with positive HBV surface antigen and HBV DNA greater than 2,000 IU/mL; bacteremia; or severe infectious pneumonia.
- 8. Uncontrolled or serious cardiovascular disease, including: - Myocardial infarction, unstable angina, congestive heart failure of New York Heart Association class 2 or higher, or another serious cardiac disorder within 6 months before the first study treatment. - A clinically significant electrocardiographic (ECG) abnormality, including clinically significant arrhythmia or corrected QT interval greater than 450 milliseconds.- Left ventricular ejection fraction below 50% on echocardiography.
- 9. Inability or unwillingness to comply with protocol requirements, or any condition that, in the investigator's judgment, makes the participant unsuitable for study participation.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseiden lukumäärä
2
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
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Kokeellinen: Cohort A: Advanced Squamous Non-Small Cell Lung Cancer(sqNSCLC)
Participants with histologically or cytologically confirmed, unresectable stage IIIB to IV squamous non-small cell lung cancer(sqNSCLC) who are not candidates for definitive chemoradiotherapy and who have completed four cycles of first-line treatment with a PD-1 or PD-L1 inhibitor, a platinum agent, and paclitaxel or nab-paclitaxel without disease progression will receive metronomic oral paclitaxel plus maintenance immune checkpoint inhibition.
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Muut nimet:
The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, eg.
Tislelizumab, Pembrolizumab, Camrelizumab and Penpulimab, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.
The maintenance PD-1/PD-L1 inhibitor should generally be the same agent used during first-line induction treatment.
Muut nimet:
|
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Kokeellinen: Cohort B: Extensive-Stage Small Cell Lung Cancer(ES-SCLC)
Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer(ES-SCLC) who have completed four cycles of first-line treatment with a PD-1 or PD-L1 inhibitor, a platinum agent, and etoposide without disease progression will receive metronomic oral paclitaxel plus maintenance immune checkpoint inhibition.
|
Muut nimet:
The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, eg.
Tislelizumab, Pembrolizumab, Camrelizumab and Penpulimab, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.
The maintenance PD-1/PD-L1 inhibitor should generally be the same agent used during first-line induction treatment.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Progression-Free Survival (PFS)
Aikaikkuna: First dose up to approximately 24 months
|
PFS is defined as the time from the date of the first oral paclitaxel administration to the first occurrence of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurred first.
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First dose up to approximately 24 months
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Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Objective Response Rate(ORR)
Aikaikkuna: First dose up to approximately 12 months
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ORR is defined as the proportion of participants whose best overall response during maintenance treatment is a complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1.
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First dose up to approximately 12 months
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12-Week PFS rate
Aikaikkuna: 12 weeks
|
The proportion of participants who are alive and have not experienced radiographic disease progression at 12 weeks after initiation of maintenance treatment.
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12 weeks
|
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Disease Control Rate (DCR)
Aikaikkuna: First dose up to approximately 12 months
|
DCR is defined as the proportion of participants whose best overall response during maintenance treatment is CR, PR or stable disease (SD) according to RECIST v1.1
|
First dose up to approximately 12 months
|
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Duration of Response (DoR)
Aikaikkuna: First dose up to approximately 12 months
|
DoR is defined for participants who achieve a CR or PR as the time from the first documented objective response to radiographic disease progression or death from any cause, whichever occurs first.
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First dose up to approximately 12 months
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Overall Survival (OS)
Aikaikkuna: First dose up to approximately 36 months
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OS is defined as the time from the first oral paclitaxel administration to death from any cause.
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First dose up to approximately 36 months
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Incidence of Adverse Events (AE)
Aikaikkuna: First dose up to approximately 36 months
|
The number and proportion of participants experiencing treatment-emergent AEs (TEAE), serious AEs (SAE), treatment-related AEs (TRAE), grade 3 or higher AEs (AE), and AEs resulting in treatment interruption, dose reduction, permanent treatment discontinuation, hospitalization, or death.
AE will be graded according to the CTCAE 5.0.
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First dose up to approximately 36 months
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Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Symptom Score
Aikaikkuna: Baseline, Week 6, Week 12, Week 24, every 12 weeks thereafter, and at the end-of-treatment visit, assessed up to 36 months
|
EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001).
All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100.
A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems.
A ≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
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Baseline, Week 6, Week 12, Week 24, every 12 weeks thereafter, and at the end-of-treatment visit, assessed up to 36 months
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Change From Baseline in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC Quality-of-Life Lung Cancer Module (QLQ-LC13) Symptom Score
Aikaikkuna: Baseline and Weeks 6, 12, and 24, every 12 weeks thereafter, and at the end-of-treatment visit, up to 36 months
|
The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001).
All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100.
A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems.
A≥10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998).
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Baseline and Weeks 6, 12, and 24, every 12 weeks thereafter, and at the end-of-treatment visit, up to 36 months
|
Muut tulostoimenpiteet
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percent Change From Baseline in Plasma Circulating Tumor DNA (ctDNA) Maximum Variant Allele Frequency (VAF) at Week 12
Aikaikkuna: Baseline and Week 12 (±14 days) after initiation of maintenance treatment
|
Plasma ctDNA will be assessed using paired blood samples collected at baseline and at Week 12 after initiation of maintenance treatment using the same prespecified next-generation sequencing panel. Among participants with at least one tumor-associated variant detectable at baseline, the maximum VAF among the baseline-tracked variants will be reported as a percentage at both time points. Percent change from baseline will be calculated as: [(Week 12 maximum VAF - baseline maximum variant allele frequency) / baseline maximum VAF] × 100. Negative values indicate a reduction in molecular tumor burden, whereas positive values indicate an increase. |
Baseline and Week 12 (±14 days) after initiation of maintenance treatment
|
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Change From Baseline in Tumor Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) at Week 12
Aikaikkuna: Baseline and Week 12 (±14 days) after initiation of maintenance treatment
|
Tumor PD-L1 expression will be assessed in paired tumor tissue samples collected at baseline and at Week 12 after initiation of maintenance treatment using the same validated immunohistochemistry (IHC) assay. PD-L1 expression will be reported as the tumor proportion score, defined as the percentage of viable tumor cells showing partial or complete membranous staining. The TPS ranges from 0% to 100%. Change from baseline will be calculated in percentage points as the Week 12 tumor proportion score minus the baseline tumor proportion score. Positive values indicate increased PD-L1 expression. This exploratory assessment will be performed in participants with evaluable paired tumor tissue samples. Post-treatment PD-L1 testing is optional for participants in Cohort B.This assessment will be performed only in participants with evaluable paired tumor tissue samples. |
Baseline and Week 12 (±14 days) after initiation of maintenance treatment
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Change From Baseline in Neutrophil-to-Lymphocyte Ratio (NLR) at Week 12
Aikaikkuna: Baseline and Week 12 (±14 days) after initiation of maintenance treatment
|
The NLR will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count obtained from the same complete blood count assessment. The NLR is unitless. Change from baseline will be calculated as the Week 12 NLR minus the baseline NLR ratio. Positive values indicate an increase in the NLR. |
Baseline and Week 12 (±14 days) after initiation of maintenance treatment
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Sponsori
Tutkijat
Tutkijat
- Päätutkija: Yueyin Pan, MD, PhD, AnHui Provincial Cancer Hospital
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
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- Zappa C, Mousa SA. Non-small cell lung cancer: current treatment and future advances. Transl Lung Cancer Res. 2016 Jun;5(3):288-300. doi: 10.21037/tlcr.2016.06.07.
- Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.
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- Jin Li et al. Paclitaxel oral solution versus paclitaxel injection as second-line therapy in advanced gastric cancer: A randomized, open-label, non-inferiority phase 3 trial.JCO 42, 4051-4051(2024).
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Hengityselinten sairaudet
- Keuhkosairaudet
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Keuhkojen kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Pienisoluinen keuhkosyöpä
- Orgaaniset kemikaalit
- Hiilivety
- Sykloparaffiinit
- Hiilivedyt, aliisykliset
- Hiilivedyt, sykliset
- Terpeenit
- Taksoidit
- Syklodekaanit
- Diterpeenit
- Paklitakseli
- pembrolitsumabi
- kamrelitsumabi
- penpulimabi
- tislelitsumabi
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 2026-LLYJ-0070
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
PÄÄTTÄMÄTÖN
IPD-suunnitelman kuvaus
Individual participant-level data are not currently planned to be made publicly available.
Aggregate study results may be presented at scientific meetings or published in peer-reviewed journals in accordance with applicable privacy, ethical, and institutional requirements.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
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