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

NCT04459663 | Unknown Phase 2

• 1 other identifier: JS001-ISS -149/JS001-ISS -CO49
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, open, single-center clinical study to evaluate the efficacy and safety of 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. About 50 subjects will be included in this study and will be treated with JS001 combined with acitinib. Each cycle is 21 days.

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 Axitinib DRUG

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• At least one measurable lesion (according to RECIST 1.1);
• Failure of previous first-line standard chemotherapy:
• Patients who agreed to provide previously stored tumor tissue specimens or fresh biopsies of tumor lesions
• Age 18-75 years old, regardless of gender;
• ECOG score 0-1;
• Expected survival time ≥ 3 months;
• Laboratory test value must show enough organ function

You may not qualify if:

• Tumor histology or cytological pathology confirmed the presence of small cell lung cancer components, or sarcomatoid lesions;
• Those who did not have a driving gene test;
• Investigator believed that there was a clear bleeding tendency
• Subjects who are currently participating in and receiving treatment in other studies, less than 4 weeks
• Patients who had previously received second-line or more systemic chemotherapy for advanced NSCLC;
• Patients who had received hematopoietic stimulating factors, within one week before the start of the study.
• Uncontrollable or symptomatic hypercalcemia
• Within 6 months before receiving the study treatment, they received chest (lung) radiotherapy \> 30Gy, or received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.
• The adverse reactions of previous antineoplastic therapy have not yet recovered to CTCAE 5.0 grade ≤ 1 (except alopecia);
• Major surgery or radiotherapy has been performed within 4 weeks before joining the group or has not yet fully recovered from the previous operation
• Known active central nervous system (CNS) metastasis and / or cancerous meningitis;
• Spinal cord compression without radical treatment of surgery and / or radiotherapy;
• Uncontrolled tumor-related pain;
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;
• Evidence of active pneumonia was found;

Sponsors & Collaborators

• Li Zhang, MD: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)