Clinical trial NCT06065813: Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
Official title: The Efficacy and Safety of Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIB-IIIA Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Neoadjuvant Therapy
Radiotherapy
Immunotherapy
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Junshi Bioscience Co., Ltd.
First posted: 2023-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Major pathologic response rates
timeFrame: 42months
measure: Event-free survival
timeFrame: 42months
Secondary outcomes:
measure: Overall survival
timeFrame: 42 months
measure: Pathologic complete response (pCR) rates
timeFrame: 42months
measure: Disease-free survival
timeFrame: 42 months
measure: Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
timeFrame: 42 months
Other outcomes:
measure: Biomarkers
timeFrame: 42 months
Locations:
city: Yangzhou
country: China
facility: People's hospital of northern jiangsu
state: Jiangsu
Study officials:
References: