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Pulmonary Pleomorphic CarcinomaPhase 2NCT05375734

Phase II, Single-arm Exploratory Clinical Study of Tislelizumab Combined With Anlotinib in the Treatment of Advanced Pulmonary Pleomorphic Carcinoma

A Phase 2 study testing Tislelizumab in combination with anlotinib in people with Pulmonary Pleomorphic Carcinoma and Immunotherapy, run by Second Affiliated Hospital of Nanchang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the efficacy and safety of tislelizumab in combination with anlotinib in patients with stage III and IV PSC . Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tislelizumab in combination with anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
17 Aug 2021to 28 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily participate in the study and sign informed consent;
  • Male or female patients aged between 18 and 80 years;
  • Patients with stage III or IV pulmonary sarcomatoid carcinoma that has been histologically or cytologically confirmed as inoperable or intolerant to radiotherapy and has at least one measurable lesion (according to RECIST V1.1 criteria);EGFR and ALK driver genes were negative.
  • Previous systemic antitumor therapy ≤2 times;
  • ECOG score: 0,1;
  • Life expectancy ≥12 weeks;
  • The main organs function normally, that is, they meet the following criteria:
  • 1) Blood examination standards should be met (no blood transfusion or blood products, g-CSF or other hematopoietic stimulating factors were used within the first 14 days) :HB ≥90 g/L；ANC ≥1.5×109/L (1500/m3)；PLT ≥100×109/L; 2) Biochemical tests shall meet the following standards:TBIL ≤1.5ULN；TBIL≤3ULN in subjects with liver metastases or with proven/suspected Gilbert's disease; ALT and AST≤2.5ULN, whereas ALT and AST≤5ULN in liver metastases. serum creatinine (Cr) ≤1.5ULN or endogenous creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula: CrCl (mL/min) =[(140- age) body weight (kg) F]/(SCr(mg/dL)72).Male F=1, female F=0.85, SCr= serum creatinine) (8) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ normal lower limit (50%); (9) Women of childbearing age must have used a reliable contraceptive method or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the trial drug.For men, consent is required to use an appropriate method of contraception or to have been surgically sterilized during the trial period and 8 weeks after the last administration of the trial drug.

Who cannot join

  • Previous antibodies or drugs targeting immune checkpoint pathways, including but not limited to anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies; (2) Treatment with systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor) within 4 weeks prior to randomization or within 5 half-lives of the drug, whichever is longer (cancer vaccine is allowed as part of previous treatment); (3) Imaging (CT or MRI) showed obvious pulmonary cavernous tumor; (4) History and complications
  • Patients with symptomatic brain metastasis, cancerous meningitis, spinal cord compression, or diseases of the brain or pia meningeal revealed by imaging CT or MRI examination during screening (patients with brain metastasis who had completed treatment 4 weeks before enrollment and had stable symptoms without progression could be enrolled, but were confirmed to have no symptoms of cerebral hemorrhage by craniocerebral MRI, CT or venography evaluation);
  • The patient is participating in other clinical studies (excluding non-interventional studies) or less than 4 weeks after the completion of treatment in the previous clinical study;
  • has had or is currently co-existing with other malignancies within the past 2 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 infiltrating basal membrane)];
  • Have an active, known or suspected autoimmune disease, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, hiv-positive history, or acquired immune deficiency syndrome (AIDS).
  • Randomize patients with any disease requiring systemic treatment with corticosteroids (prednisone >10 mg/ day or equivalent) or other immunosuppressive agents within the first 14 days of treatment.
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  • Patients who did not recover to NCI-CTCAE≤1 for adverse reactions related to previous anti-tumor therapy (except hair loss);
  • Suffering from serious cardiovascular diseases: grade ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia;Patients with grade ⅲ ~ ⅳ cardiac insufficiency according to NYHA standard, or left ventricular ejection fraction (LVEF) < 50% as indicated by color doppler echocardiography;
  • A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.Uncontrolled medium to large serous effusion (including pleural effusion, ascites, pericardial effusion), aggravated chronic obstructive pulmonary disease, and active lung infections and/or acute bacterial or fungal respiratory diseases requiring intravenous antibiotic treatment;
  • A known history of severe hypersensitivity to other monoclonal antibodies;
  • A known history of psychotropic drug abuse, alcoholism or drug abuse;
  • Active hepatitis that cannot be controlled after treatment (HEPATITIS B: HBsAg positive and HBV DNA≥1 x 103 copies /ml;Hepatitis C: HCV RNA positive and abnormal liver function);Co-infection with hepatitis B and c; (5) In the judgment of the researcher, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormal laboratory tests, or other factors that may affect the safety of the subjects, or family or social factors that may affect the collection of test data and samples.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Afiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

Other trials in China

About this study

Evaluate the efficacy and safety of tislelizumab in combination with anlotinib in patients with stage III and IV PSC .

Read the detailed description

This is a single-arm, prospective, open phase II clinical study to evaluate the efficacy and safety of tislelizumab in combination with anlotinib in patients with stage III and Stage IV PSC. The primary endpoint of this study was Objective Response Rate (ORR).

Being tested
Tislelizumab in combination with anlotinib

What participants receive

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

  • Tislelizumab in combination with anlotinibDrug

    Tislelizumab：200 mg，ivgtt，d1，Q3W anlotinib： 10mg P.O d1-d14, Q3W

Study groups in NCT05375734
Study groupRoleWhat they receive
treatment groupExperimentalTislelizumab combined with Anlotinib Tislelizumab：200 mg，ivgtt，d1，Q3W Anlotinib： 10mg P.O d1-d14, Q3W
Receives: Drug: Tislelizumab in combination with anlotinib

What is being measured

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

  1. Objective Response Rate, ORR

    ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.

    Measured: Until the disease progression, an average of 1 year

Secondary outcomes (3)

  1. Progression-free survival, PFS

    PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first PFS will be defined as the time from the date of treatment to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first

    Measured: rom date of treat until the date of first disease progression or date of death from any cause, whichever came first, assessed up to 2 years

  2. Disease Control Rate, DCR

    defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by the IRC based on RECIST v1.1 defined as the proportion of participants whose best overall response (BOR) is complete response, partial response or stable disease as determined by the IRC based on RECIST v1.1

    Measured: Until the disease progression, an average of 1 year

  3. Proportion of adverse events

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

    Measured: Up to approximately 12 months or end of treatment visit, whichever came first

Timeline

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

  1. First posted17 May 2022
  2. Study start17 Aug 2021
  3. Primary completion25 Jul 2025
  4. Study completion28 Sep 2025

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05375734
Sponsor's protocol ID
2021-PSC
Status last verified
May 2026
First submitted
10 Apr 2022
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeng Z, Huang W, Zeng F, Xiong L, Liu C, Chen Z, Zheng Y, Cai J, Huang L, Zhang X, Liu A. The Efficacy and Safety of Tislelizumab plus Anlotinib as First-line Treatment in Advanced Pulmonary Sarcomatoid Carcinoma: A Single-Arm Phase II Trial. Clin Cancer Res. 2026 Jun 15;32(12):2372-2380. doi: 10.1158/1078-0432.CCR-25-4770.

    PubMed 41894181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab in combination with anlotinib in people with Pulmonary Pleomorphic Carcinoma and Immunotherapy, run by Second Affiliated Hospital of Nanchang 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 28 May 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate, ORR (time frame: Until the disease progression, an average of 1 year). 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 NCT05375734, which also lists 1 linked publication.

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 28 May 2026.

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