New drug cocktail aims to shrink lung tumors before surgery
NCT ID NCT07089199
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This phase 2 trial tests a combination of three drugs (tislelizumab, anlotinib, and nab-paclitaxel) given before surgery to people with stage III non-small cell lung cancer. The goal is to see if this approach can eliminate or greatly reduce the tumor before it is removed. The study plans to enroll 34 participants and will also monitor side effects and long-term outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab, anlotinib, and nab-paclitaxel
- What this could lead to
- If successful, this could lead to a new treatment approach to shrink tumors before surgery and improve outcomes for people with stage III non-small cell lung cancer.
- What could go wrong
- This is a small, early-phase trial with only 34 participants and no comparison group. The combination may cause significant side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition) 3. The tumor is resectable after assessment by the attending surgeon 4. EGFR/ALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer) 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. No previous treatment received 7. At least 1 measurable lesion as defined by RECIST v1.1 8. Be able to provide the Informed Consent Form (ICF), and be able to understand and agree to abide by the research requirements and assessment schedule 9. Good organ function; • Patients have not received blood transfusion or growth factor support therapy ≤ 14 days prior to sample collection during the screening period and: Absolute neutral cell count (ANC) ≥1.5 x 109/L Platelet ≥100 x 109/L Hemoglobin ≥90 g/L • Calculated creatinine clearance (CrCl) (Cockcroft-Gault formula) creatinine clearance ≥ 45 mL/min Serum total bilirubin ≤1.5 × upper limit of normal (ULN) (patients with Gilbert\&amp;#39;s syndrome must have total bilirubin \&amp;lt; 3 × ULN) AST and ALT≤ 2.5 x ULN Patients who did not receive anticoagulant therapy: International standardized ratio or activated partial thromboplastin time ≤ 1.5 × ULN 10. Women of childbearing age must take a serum pregnancy test within 3 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must agree to use highly effective methods of contraception during the study period and for 120 days after the last dose of the study drug Exclusion Criteria: 1. A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy. 2. Patients with known EGFR gene mutation, ALK rearrangement, ROS-1 fusion, RET fusion, HER-2 mutation, MET mutation, but if patients with squamous non-small cell lung cancer, the EGFR mutation status and ALK mutation status are unknown, it is not required to conduct tests during screening 3. There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction) 4. Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients. 5. Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor invasion of important blood vessels during treatment is likely to cause fatal bleeding. 6. Clinically significant hemoptysis (more than 50 ml per day) within 3 months before the study, or clinically significant bleeding symptoms or obvious bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding, gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above baseline, or suffering from vasculitis, etc.). 7. Vaccination with attenuated live vaccines within 4 weeks before the first dose or planned vaccination during the study period. 8. Patients who are expected to be unable to tolerate surgery, such as those with cardiopulmonary insufficiency. 9. Occurrence of or concurrent other malignancies within the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\]. 10. Patients with active viral hepatitis requiring treatment as determined by the investigator. 11. Active autoimmune diseases requiring systemic treatment, or long-term use of high doses of steroids or other immunomodulators, which the investigator assesses as affecting the study treatment. 12. Unhealed surgical incisions before the start of study treatment (small biopsy incisions can be included). 13. Active hepatitis B/C infection and human immunodeficiency virus (HIV) infection. 14. Arterial or venous thrombotic events within 6 months (such as cerebrovascular accident, deep vein thrombosis, pulmonary embolism, etc.) or severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, uncontrolled arrhythmias; heart failure above grade III-IV according to NYHA standards, or left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography. 15. Interstitial lung disease, uncontrolled systemic medical history, including diabetes, hypertension, acute lung disease, etc. 16. Active bleeding or coagulation dysfunction (INR \> 2.0, PT \> 16s), bleeding tendency or receiving thrombolytic, anticoagulant, antiplatelet therapy; any major surgery requiring general anesthesia within ≤ 28 days before the first dose. 17. Underlying medical conditions or alcohol/drug abuse that are unfavorable for the administration of study drugs, may affect the interpretation of results, or pose a high risk of treatment complications.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
RECRUITINGJinan, Shandong, China
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