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

NCT ID: NCT06065813

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2026-05-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

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

Conventional segmental radiotherapy

Intervention Type: 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.

opreation

Intervention Type: OTHER

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

Interventions

Toripalimab

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

Intervention Type: DRUG

Conventional 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.

Intervention Type: RADIATION

opreation

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

Intervention Type: OTHER

Other Intervention Names

JS001

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Buhai Wang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

People's hospital of northern jiangsu

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Buhai, doctor

Role: CONTACT

wbhself@sina.com

18051062288

Facility Contacts

Buhai Wang, MD/PhD

Role: primary

wbhself@sina.com

18051062288

Other Identifiers

LC-001

Identifier Type: -

Identifier Source: org_study_id