Advanced Lung CancerPhase 1/2NCT05000684
Study of JS004 Combined With Toripalimab for Advanced Lung Cancer
A Phase 1/2 study testing JS004 in combination with toripalimab in people with Advanced Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites in China.
Trial summary
This is an open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer who have failed standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- JS004 in combination with toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesChina
- Study dates
- 27 Aug 2021to 31 Oct 2024
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the informed consent form voluntarily;
- Age greater than or equal to 18 years old at time of signing informed consent, males and females are included;
- Expected survival time is greater than or equal to 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed locally advanced (Stage III B/C), metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC);
- Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC, according to the Veterans Administration Lung Study Group (VALG) staging system);
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- At least one measurable lesion as a target lesion (RECIST v1.1 criteria);
- Agree to provide tumor tissue samples (provide fresh biopsy samples before treatment as far as possible，provide archived samples within 2 years for patients who cannot provide fresh biopsy samples before treatment;
- The subject has good organ function as indicated by screening laboratory results；
- Males of reproductive potential or females of childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine device or barrier method combined with spermicide) during the trial and continue contraception for 6 months after the end of treatment;
- Good compliance and cooperated with the follow-up；
Who cannot join
- Within 2 years prior to enrollment, had other active neoplasm malignancies except for the study disease, but excluding neoplasm malignancies expected to be cured after treatment (including but not limited to thyroid cancer, carcinoma cervix in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ after radical surgery after adequate treatment);
- Patients previously treated with anti-BTLA or anti-HVEM antibodies;
- Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
- Adverse reaction caused by prior treatment that has not recovered to CTCAE Grade 1 and below (except Grade 2 toxicity that is long-lasting, not recoverable, and does not increase safety risk);
- Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
- A large amount of hydrothorax or ascites or pericardial effusion with clinical symptoms or requiring symptomatic treatment;
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- Known history of Lung disorder: history of Interstitial pneumonia/drug-induced interstitial Pneumopathy or pneumonia, symptomatic Bronchospasm;
- Active infection requiring systemic therapy;
- A positive result for human immunodeficiency virus (HIV) antibody test;
- Known active tuberculosis (TB). For patients with suspicion of active TB should perform the test of chest X-ray, sputum, clinical signs and symptoms to exclude；
- Have a history of psychotropic drug abuse and unable to withdraw or have mental disorders;
- Pregnant or lactating woman;
- Known to be allergic to JS004 or toripalimab and its components;
- Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results；
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, 100029
Jilin Cancer Hospital
Changchun, Jilin, 130012
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab in Patients With Advanced Lung Cancer
This is an open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer who have failed standard therapy.
- Conditions
- Advanced Lung Cancer
- Being tested
- JS004 in combination with toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS004 in combination with toripalimabDrug
Also called JS004+JS001
Usage and dosage: 200mg of JS004 combined with 240mg of JS001 is given every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned | Experimental | Not described Receives: Drug: JS004 in combination with toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
Measured: 2 years
Secondary outcomes (13)
OS
Duration of Response
Measured: 2 years
DOR
Duration of Response
Measured: 2 years
DCR
Disease Control Rate
Measured: 2 years
PFS
Progression-free survival
Measured: 2 years
Cmax
Maximum Plasma Concentration
Measured: 2 years
Tmax
Time to Cmax
Measured: 2 years
AUC0-t
Area under the concentration versus time curve from time 0 to the last measurable concentration
Measured: 2 years
AUC0-inf
AUC from time 0 to infinity
Measured: 2 years
Kel
Elimination rate constant
Measured: 2 years
t1/2
Elimination half life time
Measured: 2 years
CL/F
Clearance
Measured: 2 years
Vd/F
Apparent volume of distribution
Measured: 2 years
Rac
Accumulation factor
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start27 Aug 2021
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000684
- Sponsor's protocol ID
- JS004-006-I/II-LC
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2021
- Last updated
- 20 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab in Patients With Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT05000684
- Acronym / sponsor ID
- JS004-006-I/II-LC
- Conditions
- Advanced Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Aug 2021 (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 an open-label phase I/II study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab in patients with advanced lung cancer who have failed standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned | Experimental | Drug: JS004 in combination with toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign the informed consent form voluntarily;
- Age greater than or equal to 18 years old at time of signing informed consent, males and females are included;
- Expected survival time is greater than or equal to 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed locally advanced (Stage III B/C), metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC);
Key exclusion criteria (14 listed)
- Within 2 years prior to enrollment, had other active neoplasm malignancies except for the study disease, but excluding neoplasm malignancies expected to be cured after treatment (including but not limited to thyroid cancer, carcinoma cervix in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ after radical surgery after adequate treatment);
- Patients previously treated with anti-BTLA or anti-HVEM antibodies;
- Patients previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
- Adverse reaction caused by prior treatment that has not recovered to CTCAE Grade 1 and below (except Grade 2 toxicity that is long-lasting, not recoverable, and does not increase safety risk);
- Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation in the past;
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 |
|---|---|---|
| JS004 in combination with toripalimabAlso: JS004+JS001Usage and dosage: 200mg of JS004 combined with 240mg of JS001 is given every 3 weeks | Drug | JS004 200 mg in combination with toripalimab 240 mg was administered every 3 weeks as planned |
Primary outcome
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed
Time frame: 2 years
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in vital signs, electrocardiogram, and laboratory tests
13 secondary outcomes
OS
Time frame: 2 years
DOR
Time frame: 2 years
DCR
Time frame: 2 years
PFS
Time frame: 2 years
Cmax
Time frame: 2 years
Tmax
Time frame: 2 years
AUC0-t
Time frame: 2 years
AUC0-inf
Time frame: 2 years
Kel
Time frame: 2 years
t1/2
Time frame: 2 years
CL/F
Time frame: 2 years
Vd/F
Time frame: 2 years
Rac
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JS004 in combination with toripalimab in people with Advanced Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 2 sites 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events (AE) and serious adverse events (SAE) were assessed (time frame: 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 20 Feb 2025.