Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Can… (NCT07089199) | Clinical Trial Compass
RecruitingPhase 2
Tislelizumab Combined With Anlotinib and Nab-paclitaxel in III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study
China34 participantsStarted 2025-07-25
Plain-language summary
This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-75 years old, gender is not limited;
. Histologically confirmed Stage III non-small cell lung cancer (AJCC Stage 8th edition)
. The tumor is resectable after assessment by the attending surgeon
. EGFR/ALK mutation negative or unknown (unknown only for squamous non-small cell lung cancer)
. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
. No previous treatment received
. At least 1 measurable lesion as defined by RECIST v1.1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pathological complete response (pCR)
Timeframe: Up to approximately 8 weeks following completion of neoadjuvant treatment
. 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
Exclusion criteria
. A history of received treatment for current lung cancer, including radiotherapy and all systemic antitumor agents, including chemotherapy, immunotherapy, targeted therapy or antiangiogenic therapy.
. 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
. There are multiple factors influencing patients taking oral medication (such as inability to swallow, chronic diarrhea, intestinal obstruction)
. Allergy to any study drug (Tislelizumab, Anlotinib, albumin-bound Paclitaxel) or excipients.
. 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.
. 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.).
. Vaccination with attenuated live vaccines within 4 weeks before the first dose or planned vaccination during the study period.
. Patients who are expected to be unable to tolerate surgery, such as those with cardiopulmonary insufficiency.