Non-small Cell Lung CancerPhase 2NCT04459663
JS001 Combination Therapy in NSCLC Negative Driving Gene After First-line Chemotherapy.
A Phase 2 study testing Toripalimab injection combine with Axitinib in people with Non-small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Toripalimab injection combine with Axitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- ECOG score 0-1;
- Expected survival time ≥ 3 months;
- Laboratory test value must show enough organ function
Who cannot join
- 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.
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- 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;
- Clinically uncontrolled active infections;
- Uncontrollable major seizures or superior vena cava syndrome;
- Past or present co-existence of other malignant tumors;
- Liver diseases known to be of clinical significance;
- 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;
- Patients with active tuberculosis (TB);
- Patients with any active autoimmune disease or history of autoimmune disease;
- Any anti-infective vaccine;
- Known (HIV) infection of human immunodeficiency virus;
- The researchers believe that it can affect study compliance;
- Patients who received systemic immunosuppressive drugs within the first 4 weeks of the first day of the first cycle;
- History of severe allergy, anaphylaxis or other hypersensitivity to chimeric or humanized antibodies or fusion proteins;
- Those who are known to be allergic to biological drugs;
- Those who are known to be allergic to acitinib;
- Patients with a history of arterial or venous thromboembolism;
- Known hereditary or acquired bleeding and thrombotic tendencies;
- Patients who have previously received allogeneic stem cell or parenchyma organ transplantation;
- Pregnant or lactating women or women of childbearing age who were positive for serum pregnancy test before taking the drug for the first time
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, MD, 13902282893, zhangli@sysucc.org.cn
Yunpeng Zhang, MD, 13928791406, yunpy@sysucc.org.cn
About this study
Official title: A Single-arm, Single-center, Phase II Clinical Study to Investigate the Efficacy and Safety of JS001 Combined With Axitinib in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driving Gene After First-line Chemotherapy
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
- Being tested
- Toripalimab injection combine with Axitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Toripalimab injection combine with Axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Duration of response, disease control rate, time to reponse, and progression free survival, overall survival, 6-month progression-free survival ,6-month and 1-year survival.
Measured: 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
Overall incidence of adverse events (AE); The incidence of grade 3 or above AE; the incidence of severe adverse events (SAE); the incidence of drug-related AE; the incidence of AE resulting in permanent withdrawal of drugs; the incidence of AE leading to dose adjustment / suspension trial
Measured: 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.
To evaluate the changes of TBNK lymphocyte subsets and the correlation analysis of antitumor activity under the treatment of JS001 combined with acitinib tablets,and the possible predictive factors of curative effect by biomarker analysis, including but not limited to tumor tissue lymphocyte infiltration, PMBC, PD-L1, TMB (using NGS/WES method).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start31 Aug 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhang, MD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459663
- Sponsor's protocol ID
- JS001-ISS -149/JS001-ISS -CO49
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Phase II Clinical Study to Investigate the Efficacy and Safety of JS001 Combined With Axitinib in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driving Gene After First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT04459663
- Acronym / sponsor ID
- JS001-ISS -149/JS001-ISS -CO49
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Li Zhang, MDUniversity, hospital or other
- Study start
- 31 Aug 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS001 combined with Axitinib | Experimental | Drug: Toripalimab injection combine with AxitinibJS001 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (33 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab injection combine with AxitinibThe 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 | Drug | JS001 combined with Axitinib |
Primary outcome
To evaluate the antitumor activity of Toripalimab injection (JS001) combined with Axitinib
Time frame: 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.
The objective tumor reponse rate ((ORR)) evaluated by the investigator based on the solid tumor efficacy evaluation criteria (RECIST 1.1)
3 secondary outcomes
To evaluate the efficacy of JS001 combined with Axitinib
Time frame: 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
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab injection combine with Axitinib in people with Non-small Cell Lung Cancer, run by Li Zhang, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the antitumor activity of Toripalimab injection (JS001) combined with Axitinib (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.