- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177497
SHR-1701 for Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III NSCLC
December 14, 2021 updated by: Xiaolong Fu, Shanghai Chest Hospital
A Phase II Trial of SHR-1701 Consolidation Therapy After Concurrent Chemoradiotherapy in Inoperable Stage III Non-small-cell Lung Cancer
This is a phase II, open-label, single arm study, aiming to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III non-small-cell lung cancer (NSCLC)
Study Overview
Detailed Description
The PACIFIC trial showed that durvalumab consolidation therapy significantly improved PFS and OS versus placebo for patients with unresectable stage III NSCLC after chemoradiotherapy.
Pacific regimen has become the standard of care for patients with unresectable stage III NSCLC.
SHR-1701, a novel bifunctional fusion protein composed of a mAb against PD-L1 fused with the extracellular domain of TGF-β receptor II, has demonstrated anti-tumor activity in early clinical trials.
In this study, the investigators aim to investigate the safety and efficacy of SHR-1701 consolidation therapy after concurrent chemoradiotherapy in inoperable stage III NSCLC.
Study Type
Interventional
Enrollment (Anticipated)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiao-Long Fu
- Phone Number: 13651635103
- Email: xlfu1964@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥18 years old and ≤75 years old, both male and female;
- Histologically or pathologically confirmed patients with stage III (according to the International Association for the Study of Lung Cancer and the Joint Committee on American Classification of Cancer TNM Staging System, Version 8), and to be inoperable determined by the investigator;
- The disease did not progress after receiving platinum-based concurrent chemoradiotherapy (at least 2 cycles, chemotherapy regimen: cisplatin/carboplatin combined with pemetrexed is recommended for non-squamous carcinoma, cisplatin/carboplatin combined with paclitaxel is recommended for squamous carcinoma), and the cumulative radiotherapy dose was 50-60Gy;
- ECOG PS score 0-1 points;
- The function of major organs is normal, the following standards are met: a) Routine blood examination(under 14 days without blood transfusion and no hematopoietic stimulating factor drugs for correction):hemoglobin (Hb) ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet (PLT) ≥100×10^9/L; white blood cell count (WBC) ≥3.0×10^9/L; b) Biochemical examination: alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN); serum total bilirubin(TBIL) ≤1.5×ULN; serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50ml/min; c) coagulation function: activated partial coagulation activity Enzyme time (APTT), international normalized ratio (INR), prothrombin time (PT)≤1.5×ULN; d) Doppler ultrasound assessment: left ventricular ejection fraction(LVEF)≥50%;
- The estimated survival time is at least 12 weeks;
- Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for men, it should be Surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug;
- The patient voluntarily participates and signs an informed consent form (or signed by a legal representative). It is expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.
Exclusion Criteria:
- Prior treatment with any anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies
- Driver gene mutations (EGFR mutation, ALK fusion, etc.)
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and C co-infection
- Suffer from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement) Can be included after treatment)); patients with childhood asthma that have been completely relieved and do not require any intervention or vitiligo after adulthood can be included, but patients who require medical intervention with bronchodilators cannot be included;
- Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required) within 2 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration;
- Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;
- Suffer from uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Patients with supraventricular or ventricular arrhythmia requiring clinical intervention
- Suffered from or accompanied with other systemic malignancies in the last 5 years, (except for cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer);
- Have received a preventive vaccine or attenuated vaccine within 4 weeks before the first Administration
- Those who are known to be allergic to any test drug or its excipients;
- Pregnant and lactating patients, and reproductive patients are unwilling to take effective contraceptive measures;
- Have a clear history of neurological or mental disorders, including epilepsy and dementia;
- Other circumstances deemed inappropriate by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: treatment arm
|
SHR-1701 administered by iv
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AE
Time Frame: From enrollment until confirmed disease progression; up to a maximum of approximately 2 years.
|
Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
|
From enrollment until confirmed disease progression; up to a maximum of approximately 2 years.
|
PFS
Time Frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
progression-free survival
|
Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
objective response rate
|
Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
DCR
Time Frame: Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
disease control rate
|
Tumor scans performed at baseline then every ~6 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression; up to a maximum of approximately 2 years.
|
OS
Time Frame: From baseline until death due to any cause; up to a maximum of approximately 4 years.
|
overall survival
|
From baseline until death due to any cause; up to a maximum of approximately 4 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xiao-Long Fu, Shanghai Chest Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2022
Primary Completion (Anticipated)
July 1, 2024
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
December 1, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
January 4, 2022
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
December 14, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- NSCLC-MT-IIT-SHR1701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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