A Phase 4 interventional study of Oral Paclitaxel Solution and PD-1/PD-L1 inhibitor in NSCLC (Non-small Cell Lung Cancer), sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 5 sites in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 4, Interventional, and Treatment
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.
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 78 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Oral Paclitaxel Solution · Drug: PD-1/PD-L1 inhibitor · Radiation: Stereotactic Body Radiotherapy (SBRT) · Procedure: Radical Lung Cancer Surgery
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.
Drug: Oral Paclitaxel Solution · Drug: PD-1/PD-L1 inhibitor · Radiation: Stereotactic Body Radiotherapy (SBRT) · Procedure: Radical Lung Cancer Surgery
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.
Drug: Oral Paclitaxel Solution · Drug: PD-1/PD-L1 inhibitor · Radiation: Stereotactic Body Radiotherapy (SBRT)
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.
Also known as: Oral paclitaxel, Liporaxel, DHP107
Drug page: Immune checkpoint inhibitors
An PD-1/PD-L1 inhibitor selected by the investigator according to standard of care and administered according to the approved prescribing information
SBRT at 8 Gy per fraction for 3 fractions to the primary lung tumor and selected lymph node regions.
Participants considered operable after neoadjuvant therapy are intended to undergo radical lung cancer surgery.
Participants considered inoperable after neoadjuvant therapy are intended to continue SBRT at radical dose assessed by department of radiotherapy.
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.
Time frame: 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.
Time frame: First dose up to 1 week (±7 days) after neoadjuvant therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First dose up to 1 week (±7 days) after neoadjuvant therapy
Change From Baseline in Circulating Tumor DNA (ctDNA)
Changes in ctDNA levels and molecular residual disease status will be evaluated from baseline to protocol-specified post-treatment and follow-up assessments. The association between ctDNA clearance or persistence and CR, EFS, and OS will be explored separately in Phase 2 Cohorts A and B.
Time frame: At baseline, and 1 week (±7days) after completion of neoadjuvant therapy,
Change From Baseline in PD-L1 Expression
Changes in tumor PD-L1 expression from baseline to the available post-treatment tissue assessment will be evaluated using the protocol-specified immunohistochemical assay. The association between baseline or post-treatment PD-L1 expression and CR will be explored separately in Phase 2 Cohorts A and B.
Time frame: At baseline, and 1 week (±7days) after completion of neoadjuvant therapy,
Change From Baseline in Tumor and Peripheral Immune Cell Subsets
Changes in protocol-specified tumor-infiltrating and peripheral immune cell subsets will be evaluated from baseline to post-treatment assessments. Exploratory analyses will assess the association between changes in immune cell subsets and CR, EFS, and OS separately in Phase 2 Cohorts A and B.
Time frame: At baseline, and 1 week (±7days) after completion of neoadjuvant therapy,
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Oct 2028, 28 months after the start.
Of 43 phase 4 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 48. This study's planned 28 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Paclitaxel
Carcinoma, Non-Small-Cell Lung →
Shanghai Pulmonary Hospital, Shanghai, China →