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NSCLCPhase 2TitANNCT07089199

Tislelizumab Combined With Anlotinib and Nab-paclitaxel in II-III Resectable Non-small Cell Lung Cancer : A Prospective, Single-Arm, Phase II Study

A Phase 2 study testing neoadjuvant therapy, Surgery and Adjuvant therapy in people with NSCLC and Tislelizumab, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 II-III non-small cell lung cancer.Finally, it provides new evidence-based… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC, Tislelizumab, Anlotinib
What is being tested?
neoadjuvant therapy, Surgery and Adjuvant therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
25 Jul 2025to 10 Jul 2028
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old, gender is not limited;
  • Histologically confirmed Stage II-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
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  • At least 1 measurable lesion as defined by RECIST v1.1
  • 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
  • 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\'s syndrome must have total bilirubin \< 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
  • 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

Who cannot join

  • 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.).
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  • 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.
  • 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)].
  • Patients with active viral hepatitis requiring treatment as determined by the investigator.
  • 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.
  • Unhealed surgical incisions before the start of study treatment (small biopsy incisions can be included).
  • Active hepatitis B/C infection and human immunodeficiency virus (HIV) infection.
  • 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.
  • Interstitial lung disease, uncontrolled systemic medical history, including diabetes, hypertension, acute lung disease, etc.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanguo Liu contact

18560081902

liuyanguo@sdu.edu.cn

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Yanguo Liu, 18560081902, liuyanguo@sdu.edu.cn

    Recruiting

Other trials in China

About this study

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 II-III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neoadjuvant therapyDrug

    tislelizumab （200mg，iv, q3w） + Anlotinib （10mg, orally, D1-14, q3w）+nab-paclitaxel（260mg/m2，q3w）3-4cycle

  • SurgeryProcedure or surgery

    Surgery should be performed 4 to 6 weeks after the last neoadjuvant therapy (at least 4 weeks after the end of anlotinib treatment).

  • Adjuvant therapyDrug

    Tislelizumab: 200mg, iv, Q3W, 1year at most(including preoperative treatment medication, a total of 17 cycles).

Study groups in NCT07089199
Study groupRoleWhat they receive
treatment armExperimentalParticipants received 3-4 cycles of Tislelizumab combined with anlotinib and nab-paclitaxel treatment, once every 3 weeks, for a maximum of 4 cycles. Patients who meet the surgical conditions will undergo surgery within 4 to 6 weeks after neoadjuvant therapy. After the operation, the patient entered the stage of single-agent adjuvant therapy with tislelizumab. The adjuvant therapy with tislelizumab lasted for one year (including preoperative treatment medication, a total of 17 cycles)
Receives: Drug: neoadjuvant therapy; Procedure: Surgery; Drug: Adjuvant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathological complete response (pCR)

    pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

    Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment

Secondary outcomes (5)

  1. Major Pathological Response (mPR) Rate

    mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

    Measured: Up to approximately 8 weeks following completion of neoadjuvant treatment

  2. R0 resection rate

    R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.

    Measured: usually 1 week after surgery

  3. Event-Free Survival(EFS)

    The time from the start of randomization (or the start of treatment in a one-arm trial) to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc.

    Measured: Up to 2years

  4. overall survival(OS)

    Time from randomization to death (from any cause)

    Measured: 3 years

  5. Safety and Tolerability

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start25 Jul 2025
  3. Primary completion10 Aug 2027 (estimated)
  4. Study completion10 Jul 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07089199
Sponsor's protocol ID
KYLL-202406(XZ)-009-2
Acronym
TitAN
Status last verified
Sep 2026
First submitted
20 Jul 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing neoadjuvant therapy, Surgery and Adjuvant therapy in people with NSCLC and Tislelizumab, run by Qilu Hospital of Shandong University at 1 site 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 10 inclusion and 17 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Yanguo Liu (18560081902, liuyanguo@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological complete response (pCR) (time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment). 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 NCT07089199.

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 13 Oct 2026.

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