Trials Sponsors Conditions Drugs Pricing

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

To evaluate the antitumor activity of Toripalimab injection (JS001) combined with Axitinib
The objective tumor reponse rate ((ORR)) evaluated by the investigator based on the solid tumor efficacy evaluation criteria (RECIST 1.1)
From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.

Secondary Outcomes (3)

To evaluate the efficacy of JS001 combined with Axitinib
From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.
To evaluate the safety of JS001 combined with Axitinib
From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.
To evaluate the correlation between programmed death receptor-ligand 1 (PD-L1) expression and anti-tumor response in tumor tissues.
From date of randomization untiL intolerable toxicity, or investigators determined subjects could not benefit from the study treatment, or subjects withdrew their informed consent or died, or the the drug had been used continuously for 2 years.

Study Arms (1)

JS001 combined with Axitinib

EXPERIMENTAL

JS001 combined with Axitinib in the treatment of advanced non-small cell lung cancer without activated EGFR mutation, ALK fusion and ROS fusion after or during first-line chemotherapy

Drug: Toripalimab injection combine with Axitinib

Interventions

Toripalimab injection combine with AxitinibDrug

The patients in the group will be infused intravenously with fixed dose of 240mg JS001 on the first day of each cycle. Oral Axitinib 5mg bid (recommended interval of about 12 hours) was given daily from the second day of the initial cycle

JS001 combined with Axitinib

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Toripalimab injection combine with Axitinib
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed the informed consent form (ICF);
Recurrent or advanced stage Ⅲ B or IV non-small cell lung cancer tested for EGFR mutation and ALK, ROS1 fusion gene, and all the driving gene was negative.

Sponsors & Collaborators

Li Zhang, MD
Otherlead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Li Zhang, MDCONTACT13902282893 zhangli@sysucc.org.cn

Yunpeng Zhang, MDCONTACT13928791406 yunpy@sysucc.org.cn

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmides

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

June 27, 2020

First Posted

July 7, 2020

Study Start

August 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

September 30, 2023

JS001 Combination Therapy in NSCLC Negative Driving Gene After First-line Chemotherapy.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

JS001 combined with Axitinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

JS001 combined with Axitinib

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations