Tislelizumab Combined With Tofacitinib and Docetaxel for NSCLC After Failure of First-Line Immunotherapy

November 4, 2026 updated by: Junqiang Zhang, Anhui Provincial Hospital

Tislelizumab Combined With Tofacitinib and Docetaxel for Locally Advanced or Metastatic NSCLC After Failure of First-Line Immunotherapy: A Prospective, Single-Arm, Multicenter Phase II Clinical Study

Tofacitinib is a pan-target JAK inhibitor that blocks the activation of immune cells by inhibiting the JAK1/2/3 signaling pathways. When used in combination with immune checkpoint inhibitors, it has the potential to enhance anti-tumor efficacy. This study aims to evaluate the efficacy and safety of Tislelizumab combined with Tofacitinib and Docetaxel in patients with locally advanced or metastatic NSCLC who have failed first-line immunotherapy. Additionally, the study seeks to explore potential genomic and immunological biomarkers of therapeutic response in the second-line treatment setting, providing a basis for subsequent research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with non-small cell lung cancer (NSCLC) confirmed through pathological histological examination.
  • Adenocarcinoma patients must be verified to lack driver gene mutations such as EGFR, ALK, ROS1, etc.; squamous carcinoma patients are exempt from this requirement.
  • In accordance with the 8th edition of the TNM staging classification of lung cancer by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, patients with histologically or cytologically confirmed locally advanced (stage IIIB/C) or metastatic (stage IV) NSCLC who are ineligible for surgical intervention or radical concurrent chemoradiotherapy.
  • Subjects who have previously received one PD-1/L1 inhibitor ± one platinum-based double-drug chemotherapy (either combined or sequential, with the sequence being inconsequential) and have demonstrated clinical benefit (PFS ≥ 84 days) following PD-1/L1 inhibitor treatment (with or without chemotherapy) before experiencing disease progression.
  • According to RECIST1.1 criteria, subjects must possess at least one radiologically measurable lesion. Tumor baseline radiological assessment should be conducted within 28 days prior to the initiation of medication.
  • Age range: 18 to 75 years.
  • ECOG performance status score of 0-1.
  • Normal function of major organs.
  • Women of childbearing potential must employ appropriate contraceptive measures from screening until 3 months post-study treatment cessation and must refrain from breastfeeding.
  • Patients must voluntarily participate in the study, sign informed consent, and demonstrate good compliance.

Exclusion Criteria:

  • Patients with prior exposure to JAK inhibitors.
  • Patients with active interstitial lung disease.
  • Presence of other active malignant tumors requiring concurrent treatment. Previous use of anti-tumor traditional Chinese medicine.
  • Evidence of severe or uncontrolled systemic diseases.
  • Clinically significant active infection.
  • Resting ECG showing clinically significant major abnormalities in rhythm, conduction, or morphology.
  • Myocardial infarction, coronary artery/peripheral artery bypass, or cerebrovascular accident within the past 3 months.
  • Insufficient bone marrow reserve or organ function.
  • Pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Previously or currently suffering from clinically active interstitial lung disease.
  • History of hypersensitivity to any active or inactive components of tislelizumab/tofacitinib or to drugs with similar chemical structure or same category as tislelizumab/tofacitinib.
  • Any severe or uncontrolled eye disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

Participants will receive tislelizumab combined with tofacitinib and docetaxel.
Drug: Tofacitinib Citrate Tablets

Tofacitinib citrate tablets will be given orally.

Drug: Tislelizumab

Tislelizumab will be administered as an IV infusion, 200mg, Q3W.

Drug: Docetaxel

Docetaxel will be administered per local SOC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response (ORR)
Time Frame: Up to approximately 1 year
Up to approximately 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Disease Control (DCR)
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Duration of Response (DoR)
Time Frame: Up to approximately 1 year
Up to approximately 1 year
Overall Survival (OS)
Time Frame: Up to 1 year
Up to 1 year
Incidence of Treatment-Emergent Adverse Events (TEAE)
Time Frame: Up to approximately 1 year
Up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025KY284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe