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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC

Phase II Clinical Trial Evaluating Whole Agonist-Stimulated T (WAST) Cells in Combination With Docetaxel as a Second-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) Resistant to PD-1 Inhibitors

WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC (NCT07330050) is a Phase 2 interventional studying NSCLC (Non-small Cell Lung Cancer), sponsored by Tianjin Medical University Cancer Institute and Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against NSCLC (Non-small Cell Lung Cancer) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 31 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - At screening, patients must meet the following diagnostic and treatment criteria: 1) diagnosed by tissue sample (biopsy-confirmed) NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months; - At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm; - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening; - Adequate bone marrow reserve at screening, defined as: Absolute neutrophil count (ANC) \>1.5×10⁹/L; Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥100g/L; - your organs (liver, kidneys, etc.) are working well enough based on blood tests at screening, meeting the following criteria: Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation \>91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN; - Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment. Who Should NOT Join This Trial: - Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic cancer that has spread to the brain, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * At screening, patients must meet the following diagnostic and treatment criteria: 1) Histologically or cytologically confirmed NSCLC, 2) Advanced NSCLC as determined by imaging according to AJCC V8, 3) Disease progression after first-line treatment with a PD-1 inhibitor; Expected survival time greater than 3 months; * At screening, measurable target lesions on imaging with the longest diameter greater than 1.0 cm; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening; * Adequate bone marrow reserve at screening, defined as: Absolute neutrophil count (ANC) \>1.5×10⁹/L; Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin (HGB) ≥100g/L; * Adequate organ function at screening, meeting the following criteria: Aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 ULN if due to tumor infiltration); Alanine aminotransferase (ALT) ≤2.5 times ULN (≤5 ULN if due to tumor infiltration); Total serum bilirubin ≤1.5 times ULN (≤3 ULN if due to tumor infiltration); Serum creatinine (Scr) ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; Minimum lung reserve level, defined as ≤Grade 1 dyspnea and oxygen saturation \>91% without supplemental oxygen; International Normalized Ratio (INR) ≤1.5 times ULN, and activated partial thromboplastin time (APTT) ≤1.5 times ULN; * Women of childbearing potential must have a negative urine pregnancy test, and any male or female patient capable of having children must agree to use effective contraception throughout the study and for at least 1 year after the last dose of study treatment. Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases at screening (patients with asymptomatic CNS metastases, or those who have been treated locally and are stable without symptoms for 4 weeks, are eligible); * History of CNS disorders prior to screening, such as epilepsy, cerebrovascular ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes, psychiatric disorders, or any autoimmune diseases affecting the CNS; * Received immunotherapy, targeted therapy, chemotherapy, or radiotherapy within 4 weeks before screening, and deemed unsuitable for enrollment by the investigator; * Discontinued systemic corticosteroid therapy less than 72 hours before cell infusion; however, physiological replacement doses of steroids (e.g., prednisone \<10 mg/day or equivalent) are allowed; * Any history of adoptive cell therapy prior to screening; * History of organ/tissue transplantation prior to screening; * Known active systemic autoimmune diseases under treatment prior to screening; * At screening, meets any of the following criteria: Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; Hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive, with HBV-DNA copy numbers above the lower limit of quantification; Hepatitis C antibody (HCV-Ab) positive; Treponema pallidum antibody (TP-Ab) positive; HIV antibody test positive; EBV-DNA, CMV-DNA copy numbers above the lower limit of quantification; * Undergone major surgery within 4 weeks prior to screening and deemed unsuitable for enrollment by the investigator; * History of other malignancies within the past 2 years (except successfully treated non-melanoma skin cancer or in situ carcinoma); * At screening, meets any of the following cardiac conditions: Left ventricular ejection fraction (LVEF) ≤50% (by ECHO); New York Heart Association (NYHA) class III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) or pulmonary hypertension despite standard treatment; Myocardial infarction or cardiac surgery within 12 months prior to cell infusion; Clinically significant valvular heart disease; * Tumor involvement of the atrium or ventricle at screening; * History of pulmonary interstitial fibrosis or severe chronic obstructive pulmonary disease (COPD); * Presence of clinical emergencies requiring urgent intervention due to tumor obstruction or compression (e.g., bowel obstruction or vascular compression) at screening; * Active bleeding at screening; * History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening; * Vaccinated with live vaccines within 6 weeks prior to screening; * Active infection requiring treatment at screening; * Participation in another interventional clinical study within 4 weeks prior to screening;

Treatments Being Tested

BIOLOGICAL

Whole Agonist-Stimulated T (WAST) cells injection

WAST cells (≥4.0 × 10⁹ cells), intravenous infusion, d14, Q3W for 4 cycles.

DRUG

Docetaxel

75 mg/m², intravenous infusion, day 1, Q3W.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07330050), the sponsor (Tianjin Medical University Cancer Institute and Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07330050 clinical trial studying?

This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07330050?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07330050?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07330050. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07330050. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.