Back to resultsA Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
Primary Purpose
Non-Small-Cell Lung Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1701+Paclitaxel+carboplatin
SHR-1701
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small-Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Voluntarily participate in the study and sign the informed consent form;
- 18 to 70 years old, both male and female;
- ECOG score: 0-1
- histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
- subjects who can provide fresh or archival tumor tissue;
- Measurable lesions available;
- Major organ function is basically normal;
- Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before randomization;
Exclusion Criteria:
- histologically or cytologically confirmed mixed SCLC and NSCLC;
- subjects who have malignant pleural effusion;
- Previous systemic anti-tumor therapy for NSCLC;
- Previous thoracic radiotherapy;
- Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose.
- Systemic immunostimulant therapy before the first dose;
- Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
- Subjects with autoimmune diseases;
- Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
- Known or suspected interstitial pneumonia;
- Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
- Severe cardiovascular and cerebrovascular diseases;
- Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
- Arteriovenous thrombotic events within 3 months before the first dose;
- Positive HIV test;
- Active hepatitis B or C;
- Evidence of active tuberculosis infection within 1 year before the first dose;
- Serious infection within 4 years before the first dose;
- History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
- Major surgeries other than diagnosis or biopsy within 28 days prior to first dose;
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
- History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
- Allergic to any component of the randomized treatment regimen;
- Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
- Subjects who has a known history of psychotropic drug abuse, alcoholism, or drug abuse
- Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment group A
Treatment group B
Arm Description
SHR-1701+Paclitaxel+carboplatin
SHR-1701
Outcomes
Primary Outcome Measures
ORR
Objective response rate
EFS
event free survival
Secondary Outcome Measures
OS
overall survival
EFS rate
event free survival rate
TDDM
time to death or distant metastasis
Adverse events(AEs)
Incidence of treatment-related AEs
Full Information
NCT ID
NCT04580498
First Posted
September 28, 2020
Last Updated
May 17, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04580498
Brief Title
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
Official Title
An Open-label, Multicenter Phase II Clinical Trial of SHR-1701 With or Without Chemotherapy in the Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR-1701 with or without chemotherapy in the treatment of unresectable stage III 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
SHR-1701+Paclitaxel+carboplatin
Arm Title
Treatment group B
Arm Type
Experimental
Arm Description
SHR-1701
Intervention Type
Drug
Intervention Name(s)
SHR-1701+Paclitaxel+carboplatin
Intervention Description
Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5
Intervention Type
Drug
Intervention Name(s)
SHR-1701
Intervention Description
Drug: SHR-1701 30mg/kg
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate
Time Frame
From the initiation of the first dose to 3 years
Title
EFS
Description
event free survival
Time Frame
From the initiation of the first dose to 3 years
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
From the initiation of the first dose to 3 years
Title
EFS rate
Description
event free survival rate
Time Frame
From the initiation of the first dose to 3 years
Title
TDDM
Description
time to death or distant metastasis
Time Frame
From the initiation of the first dose to 3 years
Title
Adverse events(AEs)
Description
Incidence of treatment-related AEs
Time Frame
From the initiation of the first dose to 90 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily participate in the study and sign the informed consent form;
18 to 70 years old, both male and female;
ECOG score: 0-1
histopathologically or cytologically confirmed, inoperable stage III squamous cell or non-squamous cell lung cancer;
subjects who can provide fresh or archival tumor tissue;
Measurable lesions available;
Major organ function is basically normal;
Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before randomization;
Exclusion Criteria:
histologically or cytologically confirmed mixed SCLC and NSCLC;
subjects who have malignant pleural effusion;
Previous systemic anti-tumor therapy for NSCLC;
Previous thoracic radiotherapy;
Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose.
Systemic immunostimulant therapy before the first dose;
Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
Subjects with autoimmune diseases;
Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
Known or suspected interstitial pneumonia;
Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
Severe cardiovascular and cerebrovascular diseases;
Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
Arteriovenous thrombotic events within 3 months before the first dose;
Positive HIV test;
Active hepatitis B or C;
Evidence of active tuberculosis infection within 1 year before the first dose;
Serious infection within 4 years before the first dose;
History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
Major surgeries other than diagnosis or biopsy within 28 days prior to first dose;
Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
Allergic to any component of the randomized treatment regimen;
Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
Subjects who has a known history of psychotropic drug abuse, alcoholism, or drug abuse
Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yilong Wu, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC
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