Non-Small-Cell Lung CancerNCT07599163
Oral Paclitaxel as Neoadjuvant Therapy in Elderly NSCLC: A Phase II Trial
A study testing Paclitaxel Oral Solution in people with Non-Small-Cell Lung Cancer and Neoadjuvant Therapy, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer, Neoadjuvant Therapy, Paclitaxel
- What is being tested?
- Paclitaxel Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2026to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 70-85 years, any gender
- ECOG performance status 0-1
- Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC)
- No distant metastasis, deemed resectable with curative intent
- Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology
- Adequate function of major organs, defined as:
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- Bone marrow: ANC ≥1.5×10⁹/L, platelet ≥100×10⁹/L, hemoglobin ≥9 g/dL
- Liver function: total bilirubin ≤1.5×ULN; ALT, AST ≤2.5×ULN
- Renal function: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; urine protein < +; if +, 24-h urine protein < 500 mg
- Normal blood glucose or well-controlled diabetes
- Pulmonary function: baseline FEV1 ≥2 L; if FEV1 < 2 L, postoperative predicted FEV1 > 800 mL confirmed by surgical evaluation
- Cardiac function: no myocardial infarction, unstable angina, severe arrhythmia, or cardiac insufficiency within the past 1 year
- Patients and families are fully informed and voluntarily provide written informed consent
Who cannot join
- Previous lobectomy, radiotherapy, or systemic antitumor therapy
- Synchronous other malignancy with <5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)
- History of active autoimmune disease or requirement for systemic immunosuppressive therapy
- Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B/C with active replication, or syphilis
- Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment
- Previous interstitial lung disease, drug-induced pneumonitis, or radiologic evidence of active interstitial lung disease
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- Uncontrolled massive pleural effusion or pericardial effusion
- Major surgery, severe trauma, or other investigational drug therapy within 4 weeks
- Recent vaccination with antitumor vaccines or live vaccines
- Other conditions deemed inappropriate for enrollment or likely to affect trial outcomes by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer
This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.
- Conditions
- Non-Small-Cell Lung Cancer, Neoadjuvant Therapy, Paclitaxel
- Being tested
- Paclitaxel Oral Solution
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Oral SolutionDrug
Oral Paclitaxel Solution: 200 mg/m² administered on a 21-day cycle, with oral doses given on Day 1 and Day 8 of each cycle, taken twice daily (morning and evening).
Immunotherapy: Anti-PD-1 or anti-PD-L1 monoclonal antibodies will be administered in combination. The specific agent will be selected by the investigator in accordance with the Standard of Care (SOC), and the dosing regimen will be implemented in line with the drug's official prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Oral Solution | Experimental | Not described Receives: Drug: Paclitaxel Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
pCR refers to the absence of viable residual tumor cells in surgically resected tissue samples after treatment
Measured: up to 30 months
Secondary outcomes (1)
Adverse Reaction Incidence Rate
It refers to the proportion of subjects with treatment-related adverse reactions among all enrolled subjects during the study period, which is applied to evaluate the clinical safety of the intervention measure.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start8 Jun 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599163
- Sponsor's protocol ID
- Lungmate-046
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter Clinical Study of Oral Paclitaxel Solution as Neoadjuvant Therapy in Elderly Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07599163
- Acronym / sponsor ID
- Lungmate-046
- Conditions
- Non-Small-Cell Lung Cancer, Neoadjuvant Therapy, Paclitaxel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, single-arm Phase II clinical trial, aiming to explore the safety and preliminary efficacy of oral paclitaxel solution combined with immune checkpoint inhibitors as a neoadjuvant regimen in elderly patients aged 70-85 years with non-small cell lung cancer (NSCLC). A total of 75 eligible elderly NSCLC patients who need neoadjuvant treatment are planned to be enrolled. The study takes Shanghai Pulmonary Hospital as the main center, Zhejiang Cancer Hospital and Guangdong Provincial People's Hospital as sub-centers, adopts a single-arm study design, and the research subjects are elderly NSCLC patients who need neoadjuvant treatment. The core indicators for efficacy evaluation include pathological complete response rate (pCR), major pathological response rate (MPR, residual tumor cells ≤10%), imaging response rate (according to RECIST 1.1 criteria), 2-year event-free survival rate (EFS), 2-year overall survival rate (OS), surgical resection rate, and R0 resection rate; safety evaluation mainly observes the incidence of adverse events. The statistical methods adopt the relevant specifications for single-arm exploratory studies. Efficacy analysis is carried out in the full analysis set and per-protocol set, and safety analysis is performed using the safety analysis set; for continuous variables, paired t-test or Wilcoxon signed-rank test is used according to the distribution; categorical variables are analyzed descriptively; for the main rate-type outcome indicators, the incidence rate and 95% confidence interval (Clopper-Pearson method) are reported; survival outcome indicators are estimated using the Kaplan-Meier method and relevant parameters are reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Oral Solution | Experimental | Drug: Paclitaxel Oral Solution |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Age 70-85 years, any gender
- ECOG performance status 0-1
- Pathologically confirmed non-small cell lung cancer (NSCLC), clinical stage IIA-IIIB (8th edition AJCC)
- No distant metastasis, deemed resectable with curative intent
- Negative for sensitive driver mutations including EGFR, ALK, and ROS1 by molecular pathology
Key exclusion criteria (10 listed)
- Previous lobectomy, radiotherapy, or systemic antitumor therapy
- Synchronous other malignancy with <5 years of cure (except carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin)
- History of active autoimmune disease or requirement for systemic immunosuppressive therapy
- Active infection requiring systemic therapy, including active tuberculosis, HIV infection, chronic hepatitis B/C with active replication, or syphilis
- Severe cardiac, hepatic, renal, or metabolic disease that cannot tolerate surgery or study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Oral SolutionOral Paclitaxel Solution: 200 mg/m² administered on a 21-day cycle, with oral doses given on Day 1 and Day 8 of each cycle, taken twice daily (morning and evening). Immunotherapy: Anti-PD-1 or anti-PD-L1 monoclonal antibodies will be administered in combination. The specific agent will be selected by the investigator in accordance with the Standard of Care (SOC), and the dosing regimen will be implemented in line with the drug's official prescribing information. | Drug | Paclitaxel Oral Solution |
Primary outcome
Pathological Complete Response (pCR)
Time frame: up to 30 months
pCR refers to the absence of viable residual tumor cells in surgically resected tissue samples after treatment
1 secondary outcome
Adverse Reaction Incidence Rate
Time frame: up to 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Oral Solution in people with Non-Small-Cell Lung Cancer and Neoadjuvant Therapy, run by Shanghai Pulmonary Hospital, Shanghai, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact peng zhang (13512185932, zhangpeng1121@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.