Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study assesses the safety and potential effectiveness of combining tislelizumab, tofacitinib, and docetaxel in patients with NSCLC that is locally advanced or metastatic and has progressed after initial immunotherapy. Tofacitinib blocks multiple JAK pathways, potentially enhancing anti-tumor activity when used with a checkpoint inhibitor. The trial will also explore genomic and immune biomarkers to understand who might respond better in the second-line setting. Eligible participants must have histologically confirmed NSCLC and meet staging and prior-treatment criteria, with adenocarcinoma patients lacking common driver mutations and squamous patients not required to be mutation-free. Primary outcomes focus on safety and preliminary efficacy signals, with exploratory biomarker analyses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Junqiang Zhang
• Email: yany1980@163.com
• Phone: +86 18955142161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.