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

Northern Jiangsu People's Hospital

Status and phase

Enrolling

Phase 2

Conditions

Immunotherapy

Non-small Cell Lung Cancer

Radiotherapy

Neoadjuvant Therapy

Treatments

Radiation: Conventional segmental radiotherapy

Other: opreation

Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT06065813

LC-001

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients must volunteer participating in clinical trial; patients fully understand and sign the Informed Consent Form (ICF)
18 ~ 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
Good organ function: ANC ≥ 1500/μL; PLT ≥ 100000/μL; HB ≥ 10.0g/dL; CR ≤ 1.5 × ULN or CrCl ≥ 60 mL/min (Use Cock-Gault formula); TB ≤ 1.5 × ULN (For patients with total bilirubin levels > 1.5 × ULN, direct bilirubin is within normal limits); AST and ALT ≤ 2.5 × ULN; TSH is within normal limits. Note: If TSH is not within the normal range at baseline, if T3 and free T4 are within the normal range, then the patient can still meet the inclusion criteria. IN、RPT、APTT≤1.5×ULN
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 criteria

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