AzTrials
AzTrials

Advanced Lung CancerPhase 2NCT07309276

A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer

A Phase 2 study testing JS212 for Injection, JS207 for Injection and Toripalimab in people with Advanced Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Lung Cancer
What is being tested?
JS212 for Injection, JS207 for Injection and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
864 participants
Where
1 siteChina
Study dates
23 Jan 2026to 11 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • The age between 18 and 75 years old, and any gender.
  • Local advanced, metastatic or recurrent NSCLC.
  • ES-SCLC.
  • According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), there must be at least one measurable lesion.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Expected survival period of ≥ 12 weeks.
Show all 10Show fewer
  • The functions of important organs meet the requirements.
  • Female participants with reproductive capacity (WOCBP) who have sexual life with an unsterilized male partner and who have signed the informed consent must have a negative serum pregnancy test result within 7 days before the first administration, and must agree to take effective contraceptive measures from the time of signing the ICF until 7 months after the last administration of the study.
  • Unsterilized male participants who have sexual life with a fertile female partner must agree to use the effective contraceptive measures after signing the ICF until 4 months after the last administration of the study. During this period, sperm donation is prohibited.
  • The participants voluntarily participate in this study and sign the informed consent.

Who cannot join

  • 1. Accompanying the following disease states:
  • Tumor histological or cytological pathological confirmation of combined large cell neuroendocrine carcinoma or sarcomatoid lesion, or NSCLC with small cell lung cancer component;
  • NSCLC patients with positive driver mutations;
  • Patients with known meningeal metastasis;
  • Patients with symptomatic brain metastases;
  • Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites;
Show all 37Show fewer
  • Unatable spinal cord compression;
  • 2. Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:
  • Within one month before the first use of the study drug, any clinically significant hemoptysis or tumor bleeding;
  • High bleeding risk; tumor invading important organs, high risks of perforation, esophageal-tracheal fistula, massive hemoptysis, etc.;
  • Obvious bleeding tendency or severe coagulation dysfunction history, etc;
  • Recent gastrointestinal perforation, gastrointestinal obstruction, trachea-esophageal fistula, abdominal fistula or intra-abdominal abscess, or currently having high-risk factors for hollow organ perforation/ fistula formation, or active inflammatory bowel disease, etc;
  • Presence of severe, non-healed or open wounds, active ulcers or untreated fractures;
  • Have poorly controlled hypertension;
  • Have used antiplatelet drugs or anticoagulant therapy within 14 days;
  • Have experienced a drug-related adverse event that led to permanent discontinuation of the medication during previous Bevacizumab and similar agent treatments;
  • 3. Have received any of the following treatments:
  • Immune-mediated treatments (only for part Two);
  • Have received any investigational drug within 4 weeks or 5 half-lives before the first use of the study drug;
  • Have been enrolled in another clinical study;
  • Have undergone major surgery within 4 weeks;
  • Have received local small-scale radiotherapy within 14 days;
  • 4.Have not recovered to ≤ CTCAE grade 1 toxicity or the level specified in the inclusion/exclusion criteria.
  • 5.Have known allergies to any study treatment or its excipients or have experienced an allergic reaction.
  • 6.Have experienced a drug-related AE that led to permanent discontinuation of the anti-PD-(L)1 antibody treatment.
  • 7.Have any of the following cardiac examination results:
  • Long QT;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • 8.Have a history of diagnosed or suspected ILD, drug-induced pneumonia, or other severe lung diseases.
  • 9.Have experienced a severe infection within 4 weeks.
  • 10.Have a history of immunodeficiency, or have a history of organ transplantation and allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation.
  • 11.Have active pulmonary tuberculosis infection.
  • 12.Have active hepatitis.
  • 13. Uncontrolled concurrent diseases.
  • 14. Participants who were diagnosed with any other malignant tumor within 5 years.
  • 15. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • 16. Other conditions for trial participation were not considered appropriate by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weilong Ni, Master contact

18851101030

weilong_ni@junshipharma.com

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Caicun Zhou, Ph.D, 13301825532, caicunzhoudr@163.com

    Caicun Zhou, Ph.D

    Recruiting

Other trials in China

About this study

This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.

Read the detailed description

Part One:

The plan involves including patients with previously failed standard treatments in advanced NSCLC and ES-SCLC. It consists of two phases: safety introduction and clinical expansion, covering cohorts 1 to 3.

The safety introduction phase will explore the safety of the following combined regimens in the target population:

Queue 1: JS212 + JS207 Queue 2: JS212 + Toripalimab Queue 3: JS212 + JS213

Part Two:

It is planned to include lung cancer patients who have not received any systemic anti-tumor treatment for advanced NSCLC and ES-SCLC in the past. If the SMC decides to further combine chemotherapy, the safety introduction phase should also include to ensure the safety of the subjects.

Being tested
JS212 for Injection, JS207 for Injection, Toripalimab, JS213 for Injection

What participants receive

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

  • JS212 for InjectionDrug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS207 for InjectionDrug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • ToripalimabDrug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS213 for InjectionDrug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

Study groups in NCT07309276
Study groupRoleWhat they receive
Queue 1: JS212 + JS207ExperimentalJS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS207 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
Receives: Drug: JS212 for Injection; Drug: JS207 for Injection
Queue 2: JS212 + ToripalimabExperimentalJS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. Toripalimab will be administered by intravenous infusion on Day 1 of each 21-day cycle.
Receives: Drug: JS212 for Injection; Drug: Toripalimab
Queue 3: JS212 + JS213ExperimentalJS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS213 will be administered by intravenous infusion on Day 1 of each 21-day cycle.
Receives: Drug: JS212 for Injection; Drug: JS213 for Injection

What is being measured

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

  1. ORR

    Objective response rate(ORR), assessed by BICR (RECIST v1.1)

    Measured: up to 6 years

Secondary outcomes (9)

  1. PFS

    Progression-free survival (PFS), assessed by investigators (RECIST v1.1)

    Measured: up to 6 years

  2. DoR

    Duration of response (DoR), assessed by BICR and investigators

    Measured: up to 6 years

  3. DCR

    Disease control rate (DCR), assessed by BICR and investigators

    Measured: up to 6 years

  4. OS

    overall survival (OS)

    Measured: up to 6 years

  5. Safety (AE)

    Incidence and severity of adverse events (AEs)

    Measured: up to 6 years

  6. Number of Participants With Abnormal Laboratory Values or clinical findings

    Abnormal laboratory or clinical findings

    Measured: up to 6 years

  7. dose-limiting toxicity（DLT）

    Incidence and severity of dose-limiting toxicity（DLT）

    Measured: up to 6 years

  8. blood concentrations of JS212, JS207,toriplimab, or JS213

    Evaluation of blood concentrations of JS212, JS207,toriplimab, or JS213

    Measured: up to 2 years

  9. ADA incidence

    Incidence and titers of anti-drug antibodies (ADA) for JS212,JS207,toriplimab, or JS213; neutralizing antibodies (NAb) if applicable.

    Measured: up to 4 years

Timeline

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

  1. First posted30 Dec 2025
  2. Study start23 Jan 2026
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion11 Nov 2028 (estimated)

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
864 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07309276
Sponsor's protocol ID
JS212-002-II-LC
Status last verified
May 2026
First submitted
15 Dec 2025
Last updated
18 May 2026
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 2 study testing JS212 for Injection, JS207 for Injection and Toripalimab 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 10 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weilong Ni, Master (18851101030, weilong_ni@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 6 years). 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 NCT07309276.

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 18 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in