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Taking people in ChinaPhase 4

Oral paclitaxel with immunotherapy and radiotherapy before surgery for older adults with lung cancer

Tests oral paclitaxel, immunotherapy and radiation before surgery in older lung cancer patients.

Key facts

Who runs it
Shanghai Pulmonary Hospital, Shanghai, China
Where
Guangzhou, Hangzhou, Lishui, Shanghai, and Suqian, ChinaSee the 5 sites
Trial code
Registry title
Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC
Status
Recruiting
Phase
Phase 4
People taking part
78 people, planned
Started
25 Jun 2026
Expected to end
31 Oct 2028
Type of study
Interventional, 3 groups
Treatments tested
  • Oral Paclitaxel Solution
  • PD-1/PD-L1 inhibitor
  • Stereotactic Body Radiotherapy (SBRT)
  • Radical Lung Cancer Surgery
Record updated
10 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 70 or older with lung cancer (non-small cell type) that can be removed by surgery. They get oral paclitaxel, an immunotherapy drug and focused radiotherapy before surgery.

Age
70 years or older
Sex
All sexes can join
Disease stage
Non-small cell lung cancer, clinical stage IIA-IIIB, with no spread to distant organs. The tumour must be removable by surgery and treatable with stereotactic body radiotherapy. ECOG performance status 0 or 1.
Earlier treatment
Cannot have had earlier lung surgery (lobectomy), chest radiotherapy or drug treatment for cancer.
Biomarker or test result
No sensitizing changes in the EGFR, ALK or ROS1 genes, or in other tested genes that can be targeted by treatment.

Main reasons for not taking part

  • Another cancer now, or one treated less than 5 years ago (some skin and cervical cancers excepted)
  • Active autoimmune disease, or past autoimmune disease needing drugs that suppress the immune system
  • Active infection needing treatment, active tuberculosis, HIV, active hepatitis B or C, or active syphilis
  • History of interstitial lung disease or drug-induced pneumonitis
  • Major surgery, severe injury or another investigational drug within 4 weeks before joining

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • Age 70 years or older, regardless of sex
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed non-small cell lung cancer, clinical stage IIA-IIIB according to the 8th edition of the AJCC staging system
  • No evidence of distant metastasis and considered suitable for radical lung cancer surgery
  • The primary lung lesion is suitable for stereotactic body radiotherapy
  • No sensitizing driver alterations in EGFR, ALK, ROS1, or other tested actionable genes
  • Adequate major organ function, including all of the following:
  • Absolute neutrophil count at least 1.5 × 10\^9/L, platelet count at least 100 × 10\^9/L, and hemoglobin at least 9 g/dL
  • Total bilirubin no more than 1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase no more than 2.5 × the upper limit of normal
  • Serum creatinine no more than 1.5 × the upper limit of normal or creatinine clearance at least 60 mL/min
  • Urine protein less than 1+; if urine protein is 1+, 24-hour urine protein must be less than 500 mg
  • Blood glucose within the normal range or stable glycemic control in participants with diabetes
  • Baseline forced expiratory volume in 1 second (FEV1) at least 2 L; if FEV1 is less than 2 L, the predicted postoperative FEV1 must be greater than 800 mL as assessed by a thoracic surgeon
  • No myocardial infarction within the previous year, no unstable angina, no symptomatic severe arrhythmia, and no cardiac insufficiency
  • The participant has been fully informed and voluntarily provides written informed consent

Who cannot take part

  • Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy
  • Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment
  • Recent receipt of an anticancer vaccine or live vaccine
  • Another concurrent malignancy or a history of another malignancy cured less than 5 years before enrollment, except adequately treated cervical carcinoma in situ or basal cell or squamous cell carcinoma of the skin
  • Active autoimmune disease or a history of autoimmune disease requiring systemic immunosuppressive treatment
  • Active infection requiring systemic treatment, active tuberculosis, human immunodeficiency virus infection, active hepatitis B or hepatitis C, active syphilis, or another active transmissible infection specified by the protocol
  • Severe cardiac, hepatic, renal, or metabolic disease that precludes surgery or study treatment
  • History of interstitial lung disease or drug-induced pneumonitis, or imaging evidence of active interstitial lung disease
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study or may interfere with interpretation of the study results
  • Uncontrolled large pleural effusion or pericardial effusion

Where in China

  • Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Jiatao Zhang, MD, PhDNot yet recruiting
  • Zhejiang Cancer HospitalHangzhou, ChinaContact: Weimin Mao, MD, PhDNot yet recruiting
  • Lishui People's HospitalLishui, ChinaContact: Yonghui Wang, MD, PhDNot yet recruiting
  • Shanghai Pulmonary HospitalShanghai, ChinaContact: Xiaoling Xu, MD, PhDTaking people
  • The Affiliated Suqian Hospital of Xuzhou Medical UniversitySuqian, ChinaContact: Linchun Wen, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

his multicenter, open-label, single-arm phase I/II trial will evaluate the safety, tolerability, and preliminary efficacy of oral paclitaxel solution combined with an immune checkpoint inhibitor and concurrent stereotactic body radiotherapy (SBRT) as neoadjuvant therapy in patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer (NSCLC) without sensitizing EGFR, ALK, or ROS1 alterations.

Read full original descriptionShow less

In Phase I, a 3+3 dose-escalation design will evaluate oral paclitaxel at 80, 120, and 160 mg/m² administered orally on Days 1 and 8 of each cycle, divided into morning and evening doses, in combination with an investigator-selected anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT at 8 Gy in 3 fractions. Phase II will expand enrollment at the recommended Phase II dose (RP2D). The principal efficacy outcome is pathologic complete response after surgery. Other outcomes include major pathologic response, radiographic response, event-free survival, overall survival, surgical resection and R0 resection rates, and exploratory biomarker changes.

The 3 groups in the trial

  • Phase 1 Dose-Escalation CohortTreatment being tested

    Participants enrolled in Phase 1 will receive oral paclitaxel solution in combination with an anti-PD-1 monoclonal antibody and stereotactic body radiation therapy (SBRT). Oral paclitaxel solution will be evaluated at sequential dose levels of 80 mg/m², 120 mg/m², and 160 mg/m² using a conventional 3+3 dose-escalation design. The primary objective of this cohort is to evaluate the safety and tolerability of the combination regimen and to determine the recommended Phase 2 dose (RP2D) of oral paclitaxel solution. Tumor response and surgical feasibility will be assessed after completion of the protocol-specified treatment.

    Treatment: Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor, Stereotactic Body Radiotherapy (SBRT), and Radical Lung Cancer Surgery

  • Phase 2 Cohort A - Operable CohortTreatment being tested

    Participants enrolled in Phase 2 Cohort A will be patients considered eligible for curative-intent surgery after multidisciplinary evaluation. Participants will receive oral paclitaxel solution at the RP2D established in Phase 1, in combination with an anti-PD-1 monoclonal antibody and SBRT. After completion of the protocol-specified neoadjuvant treatment, participants will undergo tumor response assessment and surgical evaluation. Participants who remain operable will proceed to curative-intent surgical resection.

    Treatment: Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor, Stereotactic Body Radiotherapy (SBRT), and Radical Lung Cancer Surgery

  • Phase 2 Cohort B - Inoperable CohortTreatment being tested

    Participants enrolled in Phase 2 Cohort B will be patients considered unsuitable for curative-intent surgery after multidisciplinary evaluation. Participants will receive oral paclitaxel solution at the RP2D established in Phase 1, in combination with an anti-PD-1 monoclonal antibody and radiotherapy. Participants will receive protocol-specified non-surgical, definitive-intent treatment and will undergo radiographic tumor response assessment and long-term survival follow-up.

    Treatment: Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor, and Stereotactic Body Radiotherapy (SBRT)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter, Open-Label, Single-Arm Phase I/II Study of Oral Paclitaxel Solution Combined With an Immune Checkpoint Inhibitor and Concurrent Stereotactic Body Radiotherapy as Neoadjuvant Treatment in Older Patients With Resectable Stage IIA-IIIB Non-Small Cell Lung Cancer
Plain-language title
Oral paclitaxel with immunotherapy and radiotherapy before surgery for older adults with lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
10 August 2026