To hear about similar clinical trials, please enter your email below
Trial Title:
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
NCT ID:
NCT06065813
Condition:
Non-small Cell Lung Cancer
Neoadjuvant Therapy
Radiotherapy
Immunotherapy
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14
doses of Toripalimab 30 days after operation
Arm group label:
Toripalimab
Other name:
JS001
Intervention type:
Radiation
Intervention name:
Conventional segmental radiotherapy
Description:
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.
Arm group label:
Toripalimab
Intervention type:
Other
Intervention name:
opreation
Description:
The operable patients will accept radical operated in 28-42 days after the third dose of
Toripalimab
Arm group label:
Toripalimab
Summary:
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA
Non-small Cell Lung Cancer
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
People's hospital of northern jiangsu
Address:
City:
Yangzhou
Zip:
225000
Country:
China
Status:
Recruiting
Contact:
Last name:
Buhai Wang, MD/PhD
Phone:
18051062288
Email:
wbhself@sina.com
Investigator:
Last name:
Buhai Wang, MD/PhD
Email:
Principal Investigator
Investigator:
Last name:
Yusheng Shu, MD/PhD
Email:
Principal Investigator
Investigator:
Last name:
Liqin Liu, master
Email:
Sub-Investigator
Investigator:
Last name:
Shichun Lu, master
Email:
Sub-Investigator
Investigator:
Last name:
Yichen Liang, MD
Email:
Sub-Investigator
Start date:
August 8, 2022
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Source:
Northern Jiangsu People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06065813
