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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: SHR-1701+Paclitaxel+carboplatin; Drug: SHR-1701

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A; SHR-1701+Paclitaxel+carboplatin	Drug: SHR-1701+Paclitaxel+carboplatin; Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5
Experimental: Treatment group B; SHR-1701	Drug: SHR-1701; Drug: SHR-1701 30mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	From the initiation of the first dose to 3 years
EFS	event free survival	From the initiation of the first dose to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	From the initiation of the first dose to 3 years
EFS rate	event free survival rate	From the initiation of the first dose to 3 years
TDDM	time to death or distant metastasis	From the initiation of the first dose to 3 years
Adverse events(AEs)	Incidence of treatment-related AEs	From the initiation of the first dose to 90 days after the last dose

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Yilong Wu, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: SHR-1701-II-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No