RecruitingPhase 2NCT06065813

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer

The Efficacy and Safety of Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIB-IIIA Non-small Cell Lung Cancer


Sponsor

Northern Jiangsu People's Hospital

Enrollment

20 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • Patients must volunteer participating in clinical trial; patients fully understand and sign the Informed Consent Form (ICF)
  • \~ 70 years old, gender not limited
  • Histologically confirmed resectable stage IIA-IIIA NSCLC without prior treatment
  • Patients must have at least one "target" lesion" to be used to assess response on this protocol as defined by RECIST 1.1
  • Agree to provide PD-L1 immune tissue sections and corresponding pathology reports for biomarker evaluation (Tumor tissue samples must be fresh or archived samples obtained within 3 months before enrollment
  • Have a performance status of 0 or 1 on the ECOG Performance Scale
  • Patients must volunteer and be able to follow research plan visits, treatment plans, laboratory tests, and other research procedures
  • According to the surgeon's assessment, the total lung function can withstand the proposed lung resection
  • Within 3 days before medication,the serum of fertile woman must be tested by hcg,and the result is negative. Fertile women can use high effective method for contraception in the duration of clinical trail and 180 days after last Administration

Exclusion Criteria17

  • Locally advanced unresectable or metastatic disease
  • Non-small small lung cancer (NSCLC) involving the upper sulcus,large cell neuroendocrine cancer (LCNEC), sarcomatoid tumor
  • Patients with known EGFR mutations or ALK translocations, non-squamous carcinoma patients need to know the status of EGFR and ALK mutations
  • Early NSCLC with prior systemic anticancer therapy, including experimental drug therapy
  • Have a history of (non-infectious) pneumonia / interstitial lung disease requiring steroid therapy, or currently have pneumonia / interstitial lung disease requiring steroid therapy
  • Known history of active tuberculosis
  • Known to have active infection requiring systemic treatment
  • known or suspected autoimmune diseases or immunodeficiency, except: patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological dose hormone replacement therapy; patients with stable type 1 diabetes whose blood glucose is controlled
  • Active hepatitis B or C
  • Has a known history of Human Immunodeficiency Virus (HIV) .
  • Received live vaccine treatment within 30 days before drug administration; but inactivated viral vaccine for seasonal influenza is allowed
  • Peripheral neuropathy ≥ grade 2
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
  • Overly sensitive reaction to other monoclonal antibodies
  • Have a history of severe allergies to pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or their preventive medicine
  • Known to have serious or uncontrolled underlying disease
  • According to the investigator's judgment, the patient has a history or current evidence of any disease, treatment or laboratory abnormality that may confuse the test results, interfere with the participant's participation in the full trial, or not in the best interest of the participant to participate in the trial

Interventions

DRUGToripalimab

200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation

RADIATIONConventional segmental radiotherapy

the does of radiation will be 40-45Gy. The day of the first dose of Toripalimab and the first day of radiation must be the same day.

OTHERopreation

The operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab


Locations(1)

People's hospital of northern jiangsu

Yangzhou, Jiangsu, China

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NCT06065813


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