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

Primary Purpose

Non-small Cell Lung Cancer, Neoadjuvant Therapy, Radiotherapy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Conventional segmental radiotherapy
opreation
Sponsored by
Northern Jiangsu Province People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • People's hospital of northern jiangsuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toripalimab

Arm Description

Outcomes

Primary Outcome Measures

Major pathologic response rates
Major pathological response rates assessed by independent center pathology
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

Secondary Outcome Measures

Overall survival
Kaplan-Meier median estimates and curves will be used to describe OS survival functions
Pathologic complete response (pCR) rates
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review.
Disease-free survival
Some time until the tumor recurs or die for various reasons
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0

Full Information

First Posted
September 6, 2023
Last Updated
September 26, 2023
Sponsor
Northern Jiangsu Province People's Hospital
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06065813
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
May 30, 2026 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Jiangsu Province People's Hospital
Collaborators
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Neoadjuvant Therapy, Radiotherapy, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toripalimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
JS001
Intervention Description
200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation
Intervention Type
Radiation
Intervention Name(s)
Conventional segmental radiotherapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
opreation
Intervention Description
The operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab
Primary Outcome Measure Information:
Title
Major pathologic response rates
Description
Major pathological response rates assessed by independent center pathology
Time Frame
42months
Title
Event-free survival
Description
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
Time Frame
42months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Kaplan-Meier median estimates and curves will be used to describe OS survival functions
Time Frame
42 months
Title
Pathologic complete response (pCR) rates
Description
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review.
Time Frame
42months
Title
Disease-free survival
Description
Some time until the tumor recurs or die for various reasons
Time Frame
42 months
Title
Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs)
Description
Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0
Time Frame
42 months
Other Pre-specified Outcome Measures:
Title
Biomarkers
Description
PD-L1 expression of tissue specimens、TMB、WES and changes of ctDNA in peripheral blood
Time Frame
42 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Buhai, doctor
Phone
18051062288
Email
wbhself@sina.com
Facility Information:
Facility Name
People's hospital of northern jiangsu
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buhai Wang, MD/PhD
Phone
18051062288
Email
wbhself@sina.com
First Name & Middle Initial & Last Name & Degree
Buhai Wang, MD/PhD
First Name & Middle Initial & Last Name & Degree
Yusheng Shu, MD/PhD
First Name & Middle Initial & Last Name & Degree
Liqin Liu, master
First Name & Middle Initial & Last Name & Degree
Shichun Lu, master
First Name & Middle Initial & Last Name & Degree
Yichen Liang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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