NSCLC (Non-small Cell Lung Cancer)Phase 4NCT07754812
Oral Paclitaxel Solution With Immunotherapy and Concurrent SBRT as Neoadjuvant Treatment for Older Adults With NSCLC
A Phase 4 study testing Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor and Stereotactic Body Radiotherapy (SBRT) in people with NSCLC (Non-small Cell Lung Cancer), run by Shanghai Pulmonary Hospital, Shanghai, China at 5 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesChina
- Study dates
- 25 Jun 2026to 31 Oct 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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 join
- Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy.
- 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.
Show all 10Show fewer
- Uncontrolled large pleural effusion or pericardial effusion.
- Major surgery, severe trauma, or treatment with another investigational drug within 4 weeks before enrollment.
- Recent receipt of an anticancer vaccine or live vaccine.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 519041
Jiatao Zhang, MD, PhD, +86-20-8382-7812, zhangjiatao@gdph.org.cn
Jiatao Zhang, MD, PhD
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Weimin Mao, MD, PhD, +86-571-88122222, zjzlyy@39.net
Weimin Mao, MD, PhD
- Not yet recruiting
Lishui People's Hospital
Lishui, Zhejiang, 323000
Yonghui Wang, MD, PhD, +86-578-2780222, hospital@mail.lsptt.zj.cn
Yonghui Wang, MD, PhD
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Xiaoling Xu, MD, PhD, +86-21-65115006, xuxl@zjcc.org.cn
Xiaoling Xu, MD, PhD
- Not yet recruiting
The Affiliated Suqian Hospital of Xuzhou Medical University
Suqian, Jiangsu, 223800
Linchun Wen, MD, PhD, +86-527-84239153, sqrmyyb@163.com
Linchun Wen, MD, PhD
About this study
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
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.
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.
Read the detailed description
Older patients with NSCLC may have reduced organ reserve, more comorbidities, and a higher risk of toxicity from standard platinum-based chemotherapy, intensive radiotherapy, or multimodality treatment. The study is designed to explore a potentially lower-intensity neoadjuvant regimen that combines oral paclitaxel solution, immune checkpoint blockade, and precision radiotherapy.
Phase I will use a conventional 3+3 dose-escalation design. Oral paclitaxel solution will be evaluated at 80, 120, and 160 mg/m² on Days 1 and 8 of each cycle, administered in divided morning and evening doses. An anti-PD-1 or anti-PD-L1 monoclonal antibody will be selected by the investigator according to standard of care and administered according to the approved prescribing information. Concurrent SBRT will be delivered at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected nodal regions. The Phase I objective is to evaluate safety and identify the RP2D.
Phase II will enroll additional participants at the RP2D to evaluate antitumor activity and feasibility. Participants who remain suitable for radical lung cancer surgery are intended to undergo resection after completion of neoadjuvant treatment. The study will assess pathologic response, radiographic response, surgical feasibility, event-free survival, overall survival, and changes in immune cell subsets, circulating tumor DNA, and PD-L1 expression.
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Being tested
- Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor, Stereotactic Body Radiotherapy (SBRT), Radical Lung Cancer Surgery
- Keywords
- Elderly patients, Neoadjuvant therapy, Oral paclitaxel solution, Immune checkpoint inhibitor, SBRT, Resectable NSCLC, Pathologic complete response
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Paclitaxel SolutionDrug
Also called Oral paclitaxel, Liporaxel, DHP107
Phase I dose levels: 80 mg/m², 120 mg/m², and 160 mg/m², administered orally on Days 1 and 8 of each cycle in divided morning and evening doses. Phase II: oral paclitaxel solution at the RP2D.
PD-1/PD-L1 inhibitorDrug
An PD-1/PD-L1 inhibitor selected by the investigator according to standard of care and administered according to the approved prescribing information
Stereotactic Body Radiotherapy (SBRT)Radiation
SBRT at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected lymph node regions.
Radical Lung Cancer SurgeryProcedure or surgery
Participants considered operable after neoadjuvant therapy are intended to undergo radical lung cancer surgery.
Stereotactic Body Radiotherapy (SBRT)Radiation
Participants considered inoperable after neoadjuvant therapy are intended to continue SBRT at radical dose assessed by department of radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose-Escalation Cohort | Experimental | 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. Receives: Drug: Oral Paclitaxel Solution; Drug: PD-1/PD-L1 inhibitor; Radiation: Stereotactic Body Radiotherapy (SBRT); Procedure: Radical Lung Cancer Surgery |
| Phase 2 Cohort A - Operable Cohort | Experimental | 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. Receives: Drug: Oral Paclitaxel Solution; Drug: PD-1/PD-L1 inhibitor; Radiation: Stereotactic Body Radiotherapy (SBRT); Procedure: Radical Lung Cancer Surgery |
| Phase 2 Cohort B - Inoperable Cohort | Experimental | 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. Receives: Drug: Oral Paclitaxel Solution; Drug: PD-1/PD-L1 inhibitor; Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate in Phase 2
The percentage of participants in the Phase 2 operable cohort who achieve a CR according to RECIST v1.1, at the protocol-specified preoperative tumor assessment.
A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in the short axis to less than 10 mm.
Participants who discontinue treatment, experience disease progression, become unable to undergo the planned response assessment, or have no evaluable post-baseline tumor assessment will be classified as not having achieved a CR.
Measured: 2 weeks (±14 days) after surgery or radical radiotherapy
Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAE) in Phase 1
The percentage of participants in the Phase 1 dose-escalation cohort who experience at least one Grade 3 or higher TRAE during the safety assessment period.
Adverse events will be graded according to the CTCAE 5.0. The relationship of each adverse event (AE) to oral paclitaxel solution, the anti-PD-1 antibody, radiotherapy, or the combination regimen will be assessed by the investigator.
Measured: First dose up to 1 week (±7 days) after neoadjuvant therapy
Secondary outcomes (4)
CR Rate in Phase 1
The percentage of participants in the Phase 1 dose-escalation cohort who achieve a CR according toRECIST v1.1.
A CR is defined as the disappearance of all target lesions, with any pathological lymph nodes having a reduction in the short axis to less than 10 mm.
Measured: 2 weeks (±14 days) after surgery
Two-Year Event-Free Survival (EFS) Rate
The percentage of participants in the Phase 1/2 who remain alive and event-free at 2 years after first dose up.
An event is defined as any of the following:
Disease progression that precludes planned curative-intent treatment; Local, regional, or distant disease progression or recurrence; Death from any cause. Participants without an event will be censored at the date of their last adequate disease assessment.
Measured: 2 years
Two-Year Overall Survival (OS) Rate
The percentage of participants in the Phase 2 who are alive at 2 years after first dose. Participants who are alive or whose survival status is unknown at the data cutoff will be censored at the date they were last known to be alive.
Measured: 2 years
Incidence of AE
The percentage of participants in Phase 2 who experience treatment-emergent adverse events (TEAE), TRAE, Grade 3 or higher AE, serious adverse events (SAE), immune-related adverse events(irAE), or radiation-related AE.
Adverse events will be graded according to CTCAE 5.0. Postoperative complications occurring during the protocol-specified postoperative safety period will also be summarized.
Measured: First dose up to 1 week (±7 days) after neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start25 Jun 2026
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NSCLC (Non-small Cell Lung Cancer)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I uses a 3+3 dose-escalation design to determine the recommended Phase II dose of oral paclitaxel solution in combination with an immune checkpoint inhibitor and concurrent SBRT. Phase II is a single-arm expansion at the recommended Phase II dose to evaluate efficacy and feasibility.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Xu, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xiaoling Xu, MD, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754812
- Sponsor's protocol ID
- K26-560
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.
PubMed 34086039Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.
PubMed 39305910Liu J, Huang X, Yang Y, Lv W, Wang Y, Xia P, Hu J. Comparison of efficacy and safety of neoadjuvant immunochemotherapy in young and elderly patients with IIA-IIIB non-small-cell lung cancer in real-world practice. BMC Pulm Med. 2024 Nov 29;24(1):592. doi: 10.1186/s12890-024-03417-8.
PubMed 39614293Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.
PubMed 38512301Chang JY, Lin SH, Dong W, Liao Z, Gandhi SJ, Gay CM, Zhang J, Chun SG, Elamin YY, Fossella FV, Blumenschein G, Cascone T, Le X, Pozadzides JV, Tsao A, Verma V, Welsh JW, Chen AB, Altan M, Mehran RJ, Vaporciyan AA, Swisher SG, Balter PA, Fujimoto J, Wistuba II, Feng L, Lee JJ, Heymach JV. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial. Lancet. 2023 Sep 9;402(10405):871-881. doi: 10.1016/S0140-6736(23)01384-3. Epub 2023 Jul 18.
PubMed 37478883Theelen WSME, Chen D, Verma V, Hobbs BP, Peulen HMU, Aerts JGJV, Bahce I, Niemeijer ALN, Chang JY, de Groot PM, Nguyen QN, Comeaux NI, Simon GR, Skoulidis F, Lin SH, He K, Patel R, Heymach J, Baas P, Welsh JW. Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Respir Med. 2021 May;9(5):467-475. doi: 10.1016/S2213-2600(20)30391-X. Epub 2020 Oct 20.
PubMed 33096027Verma S, Breadner D, Mittal A, Palma DA, Nayak R, Raphael J, Vincent M. An Updated Review of Management of Resectable Stage III NSCLC in the Era of Neoadjuvant Immunotherapy. Cancers (Basel). 2024 Mar 27;16(7):1302. doi: 10.3390/cancers16071302.
PubMed 38610980
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07754812
- Acronym / sponsor ID
- K26-560
- Conditions
- NSCLC (Non-small Cell Lung Cancer)
- Keywords
- Elderly patients, Neoadjuvant therapy, Oral paclitaxel solution, Immune checkpoint inhibitor, SBRT, Resectable NSCLC, Pathologic complete response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 10 Aug 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.
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.
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.
Detailed description
Older patients with NSCLC may have reduced organ reserve, more comorbidities, and a higher risk of toxicity from standard platinum-based chemotherapy, intensive radiotherapy, or multimodality treatment. The study is designed to explore a potentially lower-intensity neoadjuvant regimen that combines oral paclitaxel solution, immune checkpoint blockade, and precision radiotherapy.
Phase I will use a conventional 3+3 dose-escalation design. Oral paclitaxel solution will be evaluated at 80, 120, and 160 mg/m² on Days 1 and 8 of each cycle, administered in divided morning and evening doses. An anti-PD-1 or anti-PD-L1 monoclonal antibody will be selected by the investigator according to standard of care and administered according to the approved prescribing information. Concurrent SBRT will be delivered at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected nodal regions. The Phase I objective is to evaluate safety and identify the RP2D.
Phase II will enroll additional participants at the RP2D to evaluate antitumor activity and feasibility. Participants who remain suitable for radical lung cancer surgery are intended to undergo resection after completion of neoadjuvant treatment. The study will assess pathologic response, radiographic response, surgical feasibility, event-free survival, overall survival, and changes in immune cell subsets, circulating tumor DNA, and PD-L1 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase I uses a 3+3 dose-escalation design to determine the recommended Phase II dose of oral paclitaxel solution in combination with an immune checkpoint inhibitor and concurrent SBRT. Phase II is a single-arm expansion at the recommended Phase II dose to evaluate efficacy and feasibility.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose-Escalation Cohort | Experimental | Drug: Oral Paclitaxel Solution, Drug: PD-1/PD-L1 inhibitor, Radiation: Stereotactic Body Radiotherapy (SBRT), Procedure: Radical Lung Cancer SurgeryParticipants 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. |
| Phase 2 Cohort A - Operable Cohort | Experimental | Drug: Oral Paclitaxel Solution, Drug: PD-1/PD-L1 inhibitor, Radiation: Stereotactic Body Radiotherapy (SBRT), Procedure: Radical Lung Cancer SurgeryParticipants 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. |
| Phase 2 Cohort B - Inoperable Cohort | Experimental | Drug: Oral Paclitaxel Solution, Drug: PD-1/PD-L1 inhibitor, Radiation: Stereotactic Body Radiotherapy (SBRT)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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (10 listed)
- Prior lobectomy, thoracic radiotherapy, or systemic antitumor therapy.
- 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.
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 |
|---|---|---|
| Oral Paclitaxel SolutionAlso: Oral paclitaxel, Liporaxel, DHP107Phase I dose levels: 80 mg/m², 120 mg/m², and 160 mg/m², administered orally on Days 1 and 8 of each cycle in divided morning and evening doses. Phase II: oral paclitaxel solution at the RP2D. | Drug | Phase 1 Dose-Escalation Cohort, Phase 2 Cohort A - Operable Cohort, Phase 2 Cohort B - Inoperable Cohort |
| PD-1/PD-L1 inhibitorAn PD-1/PD-L1 inhibitor selected by the investigator according to standard of care and administered according to the approved prescribing information | Drug | Phase 1 Dose-Escalation Cohort, Phase 2 Cohort A - Operable Cohort, Phase 2 Cohort B - Inoperable Cohort |
| Stereotactic Body Radiotherapy (SBRT)SBRT at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected lymph node regions. | Radiation | Phase 1 Dose-Escalation Cohort, Phase 2 Cohort A - Operable Cohort, Phase 2 Cohort B - Inoperable Cohort |
| Radical Lung Cancer SurgeryParticipants considered operable after neoadjuvant therapy are intended to undergo radical lung cancer surgery. | Procedure or surgery | Phase 1 Dose-Escalation Cohort, Phase 2 Cohort A - Operable Cohort |
| Stereotactic Body Radiotherapy (SBRT)Participants considered inoperable after neoadjuvant therapy are intended to continue SBRT at radical dose assessed by department of radiotherapy. | Radiation | Phase 2 Cohort B - Inoperable Cohort |
Primary outcome
Complete Response (CR) Rate in Phase 2
Time frame: 2 weeks (±14 days) after surgery or radical radiotherapy
The percentage of participants in the Phase 2 operable cohort who achieve a CR according to RECIST v1.1, at the protocol-specified preoperative tumor assessment. A CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in the short axis to less than 10 mm. Participants who discontinue treatment, experience disease progression, become unable to undergo the planned response assessment, or have no evaluable post-baseline tumor assessment will be classified as not having achieved a CR.
Incidence of Grade 3 or Higher Treatment-Related Adverse Events (TRAE) in Phase 1
Time frame: First dose up to 1 week (±7 days) after neoadjuvant therapy
The percentage of participants in the Phase 1 dose-escalation cohort who experience at least one Grade 3 or higher TRAE during the safety assessment period. Adverse events will be graded according to the CTCAE 5.0. The relationship of each adverse event (AE) to oral paclitaxel solution, the anti-PD-1 antibody, radiotherapy, or the combination regimen will be assessed by the investigator.
4 secondary outcomes
CR Rate in Phase 1
Time frame: 2 weeks (±14 days) after surgery
Two-Year Event-Free Survival (EFS) Rate
Time frame: 2 years
Two-Year Overall Survival (OS) Rate
Time frame: 2 years
Incidence of AE
Time frame: First dose up to 1 week (±7 days) after neoadjuvant therapy
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 10 Aug 2026.
- Results publication: PubMed 34086039Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4;7(9):1-9. doi: 10.1001/jamaoncol.2021.2301. Online ahead of print.
- Results publication: PubMed 39305910Zhao ZR, Liu SL, Zhou T, Chen G, Long H, Su XD, Zhang X, Fu JH, Lin P, Zhang LJ, Rong TH, Wu JD, Li ZC, Su HL, Chen JY, Yang YP, Lin YB, Xi M, Yang H. Stereotactic body radiotherapy with sequential tislelizumab and chemotherapy as neoadjuvant therapy in patients with resectable non-small-cell lung cancer in China (SACTION01): a single-arm, single-centre, phase 2 trial. Lancet Respir Med. 2024 Dec;12(12):988-996. doi: 10.1016/S2213-2600(24)00215-7. Epub 2024 Sep 18.
- Results publication: PubMed 39614293Liu J, Huang X, Yang Y, Lv W, Wang Y, Xia P, Hu J. Comparison of efficacy and safety of neoadjuvant immunochemotherapy in young and elderly patients with IIA-IIIB non-small-cell lung cancer in real-world practice. BMC Pulm Med. 2024 Nov 29;24(1):592. doi: 10.1186/s12890-024-03417-8.
- Results publication: PubMed 38512301Sorin M, Prosty C, Ghaleb L, Nie K, Katergi K, Shahzad MH, Dube LR, Atallah A, Swaby A, Dankner M, Crump T, Walsh LA, Fiset PO, Sepesi B, Forde PM, Cascone T, Provencio M, Spicer JD. Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 May 1;10(5):621-633. doi: 10.1001/jamaoncol.2024.0057.
- Results publication: PubMed 37478883Chang JY, Lin SH, Dong W, Liao Z, Gandhi SJ, Gay CM, Zhang J, Chun SG, Elamin YY, Fossella FV, Blumenschein G, Cascone T, Le X, Pozadzides JV, Tsao A, Verma V, Welsh JW, Chen AB, Altan M, Mehran RJ, Vaporciyan AA, Swisher SG, Balter PA, Fujimoto J, Wistuba II, Feng L, Lee JJ, Heymach JV. Stereotactic ablative radiotherapy with or without immunotherapy for early-stage or isolated lung parenchymal recurrent node-negative non-small-cell lung cancer: an open-label, randomised, phase 2 trial. Lancet. 2023 Sep 9;402(10405):871-881. doi: 10.1016/S0140-6736(23)01384-3. Epub 2023 Jul 18.
- Results publication: PubMed 33096027Theelen WSME, Chen D, Verma V, Hobbs BP, Peulen HMU, Aerts JGJV, Bahce I, Niemeijer ALN, Chang JY, de Groot PM, Nguyen QN, Comeaux NI, Simon GR, Skoulidis F, Lin SH, He K, Patel R, Heymach J, Baas P, Welsh JW. Pembrolizumab with or without radiotherapy for metastatic non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Respir Med. 2021 May;9(5):467-475. doi: 10.1016/S2213-2600(20)30391-X. Epub 2020 Oct 20.
- Results publication: PubMed 38610980Verma S, Breadner D, Mittal A, Palma DA, Nayak R, Raphael J, Vincent M. An Updated Review of Management of Resectable Stage III NSCLC in the Era of Neoadjuvant Immunotherapy. Cancers (Basel). 2024 Mar 27;16(7):1302. doi: 10.3390/cancers16071302.
- 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.
Xiaoling Xu, MD, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Paclitaxel Solution, PD-1/PD-L1 inhibitor and Stereotactic Body Radiotherapy (SBRT) in people with NSCLC (Non-small Cell Lung Cancer), run by Shanghai Pulmonary Hospital, Shanghai, China at 5 sites in 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 15 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoling Xu, MD, PhD (+86-21-65115006, xuxl@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate in Phase 2 (time frame: 2 weeks (±14 days) after surgery or radical radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07754812, which also lists 7 linked publications.
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 10 Aug 2026.