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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04580498
• Collaborator: (none)
• Enrollment: 122
• Arms: 2
• Anticipated Duration (Months): 28.5

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Cancer	Drug: SHR-1701+Paclitaxel+carboplatin; Drug: SHR-1701	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 15, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ORR [From the initiation of the first dose to 3 years]

   Objective response rate

2. EFS [From the initiation of the first dose to 3 years]

   event free survival

Secondary Outcome Measures

1. OS [From the initiation of the first dose to 3 years]

   overall survival

2. EFS rate [From the initiation of the first dose to 3 years]

   event free survival rate

3. TDDM [From the initiation of the first dose to 3 years]

   time to death or distant metastasis

4. Adverse events(AEs) [From the initiation of the first dose to 90 days after the last dose]

   Incidence of treatment-related AEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

• Principal Investigator: Yilong Wu, MD, Guangdong General Hospital & Guangdong Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04580498
• Other Study ID Numbers: SHR-1701-II-205
• First Posted: Oct 8, 2020
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Paclitaxel; Carboplatin

Study Results

No Results Posted as of Oct 8, 2020