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Taking people in ChinaPhase 2

Tests JS212 combinations in adults with advanced lung cancer

Tests JS212 with other drugs, with or without chemotherapy, in adults with advanced lung cancer.

Key facts

Who runs it
Shanghai Junshi Bioscience Co., Ltd.
Where
Shanghai, ChinaSee the site
Trial code
Registry title
A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer
Status
Recruiting
Phase
Phase 2
People taking part
864 people, planned
Started
23 Jan 2026
Expected to end
11 Nov 2028
Type of study
Interventional, 3 groups
Treatments tested
  • JS212 for Injection
  • JS207 for Injection
  • Toripalimab
  • JS213 for Injection
Record updated
18 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer (ES-SCLC) to test JS212 in combination therapy.

Age
18 to 75 years old.
Sex
All sexes can join.
Disease stage
Locally advanced, metastatic or recurrent NSCLC, or ES-SCLC. At least one measurable tumor lesion (RECIST v1.1). ECOG performance status 0 or 1. Expected survival of at least 12 weeks.
Earlier treatment
Cannot join if they had an investigational drug within 4 weeks or 5 half-lives, major surgery within 4 weeks, or local small-scale radiotherapy within 14 days. Side effects from earlier treatment must have eased to grade 1 or less.
Biomarker or test result
NSCLC with positive driver mutations cannot join.

Main reasons for not taking part

  • NSCLC with positive driver mutations
  • Symptomatic brain metastases or known meningeal metastasis
  • Interstitial lung disease, drug-induced pneumonia or other severe lung disease in the past
  • Immunodeficiency, organ transplant, or bone marrow or stem cell transplant
  • Pregnant, breastfeeding or planning pregnancy; another cancer within 5 years

The registry criteria, word for word

Show all 38 criteriaShow less

Who can take part

  • 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
  • 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 take part

  • Within one month before the first use of the study drug, any clinically significant hemoptysis or tumor bleeding
  • 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
  • Have received any of the following treatments:
  • Have received any investigational drug within 4 weeks or 5 half-lives before the first use of the study drug
  • 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:
  • Uncontrolled concurrent diseases
  • 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
  • Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:
  • 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
  • Have poorly controlled hypertension
  • Participants who were diagnosed with any other malignant tumor within 5 years
  • Other conditions for trial participation were not considered appropriate by the investigator
  • 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
  • NSCLC patients with positive driver mutations
  • Patients with known meningeal metastasis
  • Patients with symptomatic brain metastases
  • Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites
  • Unatable spinal cord compression
  • Presence of severe, non-healed or open wounds, active ulcers or untreated fractures
  • Immune-mediated treatments (only for part Two)
  • Have been enrolled in another clinical study
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Shanghai East HospitalShanghai, ChinaContact: Caicun Zhou, Ph.DTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Queue 1: JS212 + JS207Treatment being tested

    JS212 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.

    Treatment: JS212 for Injection and JS207 for Injection

  • Queue 2: JS212 + ToripalimabTreatment being tested

    JS212 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.

    Treatment: JS212 for Injection and Toripalimab

  • Queue 3: JS212 + JS213Treatment being tested

    JS212 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.

    Treatment: JS212 for Injection and JS213 for Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer
Plain-language title
Tests JS212 combinations in adults with advanced lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07309276, who can take part
Record updated
18 May 2026