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

NCT ID: NCT04459663

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS001 combined with Axitinib

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

Group Type: EXPERIMENTAL

Toripalimab injection combine with Axitinib

Intervention Type: 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

Interventions

Toripalimab injection combine with Axitinib

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed the informed consent form (ICF);

2. 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.

3. At least one measurable lesion (according to RECIST 1.1);

4. Failure of previous first-line standard chemotherapy:

5. Patients who agreed to provide previously stored tumor tissue specimens or fresh biopsies of tumor lesions

6. Age 18-75 years old, regardless of gender;

7. ECOG score 0-1;

8. Expected survival time ≥ 3 months;

9. Laboratory test value must show enough organ function

Exclusion Criteria

1. Tumor histology or cytological pathology confirmed the presence of small cell lung cancer components, or sarcomatoid lesions;

2. Those who did not have a driving gene test;

3. Investigator believed that there was a clear bleeding tendency

4. Subjects who are currently participating in and receiving treatment in other studies, less than 4 weeks

5. Patients who had previously received second-line or more systemic chemotherapy for advanced NSCLC;

6. Patients who had received hematopoietic stimulating factors, within one week before the start of the study.

7. Uncontrollable or symptomatic hypercalcemia

8. 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.

9. The adverse reactions of previous antineoplastic therapy have not yet recovered to CTCAE 5.0 grade ≤ 1 (except alopecia);

10. Major surgery or radiotherapy has been performed within 4 weeks before joining the group or has not yet fully recovered from the previous operation

11. Known active central nervous system (CNS) metastasis and / or cancerous meningitis;

12. Spinal cord compression without radical treatment of surgery and / or radiotherapy;

13. Uncontrolled tumor-related pain;

14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage ;

15. Evidence of active pneumonia was found;

16. Clinically uncontrolled active infections;

17. Uncontrollable major seizures or superior vena cava syndrome;

18. Past or present co-existence of other malignant tumors;

19. Liver diseases known to be of clinical significance;

20. Those who have previously used any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody and Axitinib;

21. Patients with active tuberculosis (TB);

22. Patients with any active autoimmune disease or history of autoimmune disease;

23. Any anti-infective vaccine;

24. Known (HIV) infection of human immunodeficiency virus;

25. The researchers believe that it can affect study compliance;

26. Patients who received systemic immunosuppressive drugs within the first 4 weeks of the first day of the first cycle;

27. History of severe allergy, anaphylaxis or other hypersensitivity to chimeric or humanized antibodies or fusion proteins;

28. Those who are known to be allergic to biological drugs;

29. Those who are known to be allergic to acitinib;

30. Patients with a history of arterial or venous thromboembolism;

31. Known hereditary or acquired bleeding and thrombotic tendencies;

32. Patients who have previously received allogeneic stem cell or parenchyma organ transplantation;

33. Pregnant or lactating women or women of childbearing age who were positive for serum pregnancy test before taking the drug for the first time

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Facility Contacts

Li Zhang, MD

Role: primary

zhangli@sysucc.org.cn

13902282893

Yunpeng Zhang, MD

Role: backup

yunpy@sysucc.org.cn

13928791406

Other Identifiers

JS001-ISS -149/JS001-ISS -CO49

Identifier Type: -

Identifier Source: org_study_id