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Advanced Lung CancerPhase 1/2NCT05664971

JS004 Combined With Toripalimab and With Standard Chemotherapy Treat Patients With Advanced Lung Cancer

A Phase 1/2 study testing Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection, Toripalimab and Docetaxel in people with Advanced Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab and with or without standard chemotherapy in patients with advanced lung cancer 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?
Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection, Toripalimab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteChina
Study dates
9 Feb 2023to 23 Oct 2025
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

  • Subjects are eligible for the study if they meet all of the following criteria:
  • Sign the informed consent form voluntarily;
  • Males or females ≥18 years at the time of signing the informed consent;
  • Expected survival ≥3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;
  • Pathologically confirmed locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), which is currently not suitable for local treatment such as radical surgery or radiotherapy; For subjects with non-squamous carcinoma, there is no EGFR sensitive mutation or ALK fusion; for subjects with squamous carcinoma, genetic testing is not mandatory
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  • Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC, according to the Veterans Administration Lung Study Group (VALG) staging), previously received no systemic anti-tumor therapy for ES-SCLC (Cohort 5); Subjects with limited-stage SCLC who have previously received systemic anti-tumor therapy cannot be enrolled;
  • The subject has at least one measurable lesion as a target lesion (RECIST v1.1 criteria,);
  • The subject agrees to provide tumor tissue samples ;
  • 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 during the trial and continue for 6 months after the end of treatment;
  • The subject has good compliance and cooperates with the follow-up.

Who cannot join

  • Subjects who met any of the following criteria will be excluded from the study:
  • For the third line and second line populations with advanced lung squamous carcinoma (Cohorts 1 and 2), subjects who have received systemic anti-tumor therapy within 3 weeks before the first dose of study drug, including: chemotherapy, targeted therapy, anti-vascular drug therapy, biological therapy, immunotherapy, radiotherapy or other treatments with investigational products
  • Any adverse reactions caused by previous treatments have not recovered to CTCAE (Version 5.0) Grade 1 or below ;
  • Symptomatic metastases to central nervous system.;
  • Subjects with poorly controlled tumor-related pain who require analgesic treatment must receive the treatment at a stable dose before participating in the study;
  • Hydrothorax or ascites or pericardial effusion with clinical symptoms or unstable condition after symptomatic treatment;
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  • Subjects previously discontinued treatment due to PD-1/PD-L1 inhibitor toxicity;
  • Known history of severe allergic reactions to JS004 or toripalimab and its components, scheduled chemotherapeutic drugs and their components;
  • Known active or suspected autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease;
  • History of interstitial lung disease or drug-induced interstitial lung disease or pulmonitis;
  • Received systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive drugs within 14 days before the first study dose;
  • Subjects with a past history of immunodeficiency, including those with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation, or have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
  • Had received live vaccines within 4 weeks before the first study dose;
  • Any major surgical procedure within 4 weeks before the first study dose. Planned major surgical procedure to be performed within 30 days after the first dose , or not fully recovered from the previous surgery;
  • Suffering from severe cardiovascular and cerebrovascular diseases;
  • Subjects with uncontrolled or serious underlying diseases, including but not limited to active infection requiring systemic antibiotic treatment;
  • Positive human immunodeficiency virus (HIV) antibody test, active hepatitis B or C;
  • Known active Pulmonary tuberculosis (TB)..
  • Any active malignancy other than the disease under study within the past 2 years, except for malignancies that can be expected to be cured after treatment;
  • Subjects who have a history of psychotropic drug abuse and are unable to withdraw or have mental disorder;
  • Pregnant or breastfeeding woman;
  • Other severe, acute or chronic medical or psychiatric disorders or laboratory abnormalities that, at the discretion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-BTLA Monoclonal Antibody (JS004) Injection Combined With Toripalimab and With Standard Chemotherapy in Patients With Advanced Lung Cancer

This is an open-label phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and initial efficacy of JS004 injection combined with toripalimab and with or without standard chemotherapy in patients with advanced lung cancer

Being tested
Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection, Toripalimab, Docetaxel, Pemetrexed, Cisplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant humanized anti-BTLA monoclonal antibody (JS004) injectionBiological

    200mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol

  • ToripalimabBiological

    240mg via IV infusion once every 3 weeks;JS004 will be administered in combination with toripalimab until disease progression or intolerable toxicity or up to 2 years of treatment or other reasons specified in the protocol

  • DocetaxelDrug

    60 or 75mg/m2 via IV infusion on Day 1 of a 21-day cycle, which may be maintained until disease progression

  • PemetrexedDrug

    500mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles; Subjects who have disease progression after 4 cycles may continue to receive maintenance treatment with pemetrexed

  • CisplatinDrug

    75mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

  • CarboplatinDrug

    AUC 5 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

  • PaclitaxelDrug

    175mg/m2 via IV infusion on Day 1 of a 21-day cycle for 4 cycles

  • EtoposideDrug

    100mg/m2 via IV infusion on Days 1, 2, and 3 of a 21-day cycle for 4 cycles

Study groups in NCT05664971
Study groupRoleWhat they receive
Cohort 1ExperimentalNSCLC-squamous carcinoma third line;JS004 200mg + JS001 240mg Q3w, maintained until disease progression
Receives: Biological: Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection; Biological: Toripalimab
Cohort 2ExperimentalNSCLC-squamous carcinoma second line;JS004 200mg + JS001 240 mg + docetaxel Q3w, maintained until disease progression
Receives: Biological: Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection; Biological: Toripalimab; Drug: Docetaxel
Cohort 3ExperimentalNSCLC-non-squamous carcinoma first line;JS004 200mg + JS001 240 mg + pemetrexed + carboplatin/cisplatin Q3w, for 4 cycles;JS004 200mg + JS001 240 mg + pemetrexed, maintained until disease progression
Receives: Biological: Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection; Biological: Toripalimab; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Cohort 4ExperimentalNSCLC-squamous cell carcinoma first line;JS004 200mg + JS001 240 mg + paclitaxel + carboplatin Q3w, for 4 cycles; JS004 200mg + JS001 240 mg, maintained until disease progression
Receives: Biological: Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection; Biological: Toripalimab; Drug: Carboplatin; Drug: Paclitaxel
Cohort 5ExperimentalSCLC first line;JS004 200mg + JS001 240 mg + etoposide + carboplatin/cisplatin Q3w, for 4 cycles; JS004 200mg + JS001 240 mg, maintained until disease progression
Receives: Biological: Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection; Biological: Toripalimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Incidence of adverse events (AEs)

    Measured: 2 years

  2. Incidence of SAEs

    Incidence of serious adverse events (SAEs)

    Measured: 2 years

  3. Incidence of irAEs

    Incidence of immune-related adverse events (irAEs)

    Measured: 2 years

  4. ORR

    Efficacy endpoint: objective response rate (ORR) based on RECIST v1.1 criteria

    Measured: 2 years

Secondary outcomes (11)

  1. DOR

    Efficacy endpoints: duration of response

    Measured: 2 years

  2. DCR

    Efficacy endpoints: disease control rate

    Measured: 2 years

  3. time to response (TTR)

    Efficacy endpoints: time to response

    Measured: 2 years

  4. PFS

    Efficacy endpoints: progression-free survival

    Measured: 2 years

  5. OS

    Efficacy endpoints: overall survival (OS)

    Measured: 2 years

  6. 1-year OS rate

    Efficacy endpoints: 1-Year overall survival (OS) rate

    Measured: 1 year

  7. Drug concentration in plasma

    drug concentration at different time points after administration in an individual subject

    Measured: 2 years

  8. incidence of ADA

    incidence of anti-drug antibodies (ADA)

    Measured: 2 years

  9. titer of ADA

    titer of anti-drug antibodies (ADA)

    Measured: 2 years

  10. incidence of Nab

    incidence of neutralizing antibodies (Nab)

    Measured: 2 years

  11. titer of Nab

    titer of neutralizing antibodies (Nab)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2022
  2. Study start9 Feb 2023
  3. Primary completion23 Oct 2025
  4. Study completion23 Oct 2025

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05664971
Sponsor's protocol ID
JS004-007-Ib/II-LC
Status last verified
Dec 2025
First submitted
28 Nov 2022
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection, Toripalimab and Docetaxel in people with Advanced Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. 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 12 inclusion and 22 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 2 Dec 2025. 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 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?

Incidence of adverse events (AEs) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05664971.

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 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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