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

NCT06065813 | Recruiting Phase 2

• 1 other identifier: LC-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer; Neoadjuvant Therapy; Radiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Major pathologic response rates

  Major pathological response rates assessed by independent center pathology

  42months

• Event-free survival

  The time from the beginning of enrollment to the occurrence of any events, including death, disease progression, change of chemotherapy regimen, change of chemotherapy, addition of other treatments, the occurrence of fatal or intolerant side effects and other events

  42months

Secondary Outcomes (4)

• Overall survival

  42 months

• Pathologic complete response (pCR) rates

  42months

• Disease-free survival

  42 months

• Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)

  42 months

Other Outcomes (1)

• Biomarkers

  42 months

Study Arms (1)

Toripalimab

EXPERIMENTAL

Drug: Toripalimab; Radiation: Conventional segmental radiotherapy; Other: opreation

Interventions

Toripalimab DRUG

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

Also known as: JS001

Toripalimab

Conventional segmental radiotherapy RADIATION

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.

Toripalimab

opreation OTHER

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

Toripalimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead
• Shanghai Junshi Bioscience Co., Ltd.: collaborator

Study Sites (1)

People's hospital of northern jiangsu

Yangzhou, Jiangsu, 225000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wang Buhai, doctor

CONTACT

18051062288; wbhself@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: October 4, 2023
• Study Start: August 8, 2022
• Primary Completion: May 30, 2026
• Study Completion: May 30, 2026
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)