A Trial of SHR-1701 With or Without Chemotherapy in Patients With Stage III NSCLC

Non-Small-Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04580498
• Other study ID #: SHR-1701-II-205
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 10, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Est. completion date: March 1, 2025
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Drug:
• SHR-1701+Paclitaxel+carboplatin
Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5
• SHR-1701
Drug: SHR-1701 30mg/kg

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective response rate	From the initiation of the first dose to 3 years
Primary	EFS	event free survival	From the initiation of the first dose to 3 years
Secondary	OS	overall survival	From the initiation of the first dose to 3 years
Secondary	EFS rate	event free survival rate	From the initiation of the first dose to 3 years
Secondary	TDDM	time to death or distant metastasis	From the initiation of the first dose to 3 years
Secondary	Adverse events(AEs)	Incidence of treatment-related AEs	From the initiation of the first dose to 90 days after the last dose