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Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung Cancer

ConditionsNSCLC, Stage IIIANSCLC (non-small Cell Lung Cancer)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University

About this trial

To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2/III non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer

All patients received baseline PET/CT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging

Cytology/histology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer

For non-squamous cell carcinoma patients, if EGFR/ALK mutation status is unknown, tissue samples should be provided for EGFR/ALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR/ALK mutation status is unknown, testing is not required during screening

Disqualifiers

The patient presents with a confirmed or suspected autoimmune disorder.

Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto's thyroiditis who are hypothyroid but require only hormone replacement therapy may be included in the study if there are no obvious signs of relapse

Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone [or equivalent]/day) or received other immunosuppressive medications within 14 days prior to enrollment.

Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (≥10mg prednisolone [or equivalent]/day) can also be accepted for individuals lacking clear evidence of autoimmune disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Tislelizumab Combined With Chemotherapy

    Drug

    Tislelizumab 200mg Q3W，Platinum-containing dual drug chemotherapy

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: TislelizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Surgical conversion rate

After 3 cycles of Tislelizumab combined with chemotherapy, the number of patients who underwent surgical resection/number of patients enrolled

Time frame
Within 4-6 weeks (+7 days) after the third cycle of Tislelizumab combined with chemotherapy

Secondary outcomes

1

Major pathologic response(MPR)

Less than 10% of tumor cells remained in the pathological excision specimen

Time frame
Within one week after surgery
2

Pathologic Complete response（pCR）

No tumor cells were observed in pathological excision specimens

Time frame
Within one week after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: