Clinical trial NCT04580498: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: ORR
timeFrame: From the initiation of the first dose to 3 years
measure: EFS
timeFrame: From the initiation of the first dose to 3 years
Secondary outcomes:
measure: OS
timeFrame: From the initiation of the first dose to 3 years
measure: EFS rate
timeFrame: From the initiation of the first dose to 3 years
measure: TDDM
timeFrame: From the initiation of the first dose to 3 years
measure: Adverse events(AEs)
timeFrame: From the initiation of the first dose to 90 days after the last dose
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: