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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Lung Cancer
• Intervention / Treatment: Drug: JS212 for Injection; Drug: JS207 for Injection; Drug: Toripalimab; Drug: JS213 for Injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 864
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weilong Ni, Master; Phone Number: 18851101030; Email: weilong_ni@junshipharma.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200120
      • Recruiting
      • Shanghai East Hospital
      • Contact: Caicun Zhou, Ph.D; Phone Number: 13301825532; Email: caicunzhoudr@163.com
      • Principal Investigator: Caicun Zhou, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The age between 18 and 75 years old, and any gender.
2. Local advanced, metastatic or recurrent NSCLC.
3. ES-SCLC.
4. According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), there must be at least one measurable lesion.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Expected survival period of ≥ 12 weeks.
7. The functions of important organs meet the requirements.
8. 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.
9. 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.
10. The participants voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. Accompanying the following disease states:

1. Tumor histological or cytological pathological confirmation of combined large cell neuroendocrine carcinoma or sarcomatoid lesion, or NSCLC with small cell lung cancer component;
2. NSCLC patients with positive driver mutations;
3. Patients with known meningeal metastasis;
4. Patients with symptomatic brain metastases;
5. Uncontrolled pleural effusion, pericardial effusion, or recurrent ascites;
6. Unatable spinal cord compression;

2. Participants in Cohort 1 and Cohort 4 need to exclude any of the following conditions:

1. Within one month before the first use of the study drug, any clinically significant hemoptysis or tumor bleeding;
2. High bleeding risk; tumor invading important organs, high risks of perforation, esophageal-tracheal fistula, massive hemoptysis, etc.;
3. Obvious bleeding tendency or severe coagulation dysfunction history, etc;
4. 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;
5. Presence of severe, non-healed or open wounds, active ulcers or untreated fractures;
6. Have poorly controlled hypertension;
7. Have used antiplatelet drugs or anticoagulant therapy within 14 days;
8. 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:

1. Immune-mediated treatments (only for part Two);
2. Have received any investigational drug within 4 weeks or 5 half-lives before the first use of the study drug;
3. Have been enrolled in another clinical study;
4. Have undergone major surgery within 4 weeks;
5. 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:

1. Long QT;
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Queue 1: JS212 + JS207; 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.	Drug: JS212 for Injection; Administered by intravenous infusion on Day 1 of each 21-day cycle.; Drug: JS207 for Injection; Administered by intravenous infusion on Day 1 of each 21-day cycle.
Experimental: Queue 2: JS212 + Toripalimab; 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.	Drug: JS212 for Injection; Administered by intravenous infusion on Day 1 of each 21-day cycle.; Drug: Toripalimab; Administered by intravenous infusion on Day 1 of each 21-day cycle.
Experimental: Queue 3: JS212 + JS213; 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.	Drug: JS212 for Injection; Administered by intravenous infusion on Day 1 of each 21-day cycle.; Drug: JS213 for Injection; Administered by intravenous infusion on Day 1 of each 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate(ORR), assessed by BICR (RECIST v1.1)	up to 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival (PFS), assessed by investigators (RECIST v1.1)	up to 6 years
DoR	Duration of response (DoR), assessed by BICR and investigators	up to 6 years
DCR	Disease control rate (DCR), assessed by BICR and investigators	up to 6 years
OS	overall survival (OS)	up to 6 years
Safety (AE)	Incidence and severity of adverse events (AEs)	up to 6 years
Number of Participants With Abnormal Laboratory Values or clinical findings	Abnormal laboratory or clinical findings	up to 6 years
dose-limiting toxicity（DLT）	Incidence and severity of dose-limiting toxicity（DLT）	up to 6 years
blood concentrations of JS212, JS207,toriplimab, or JS213	Evaluation of blood concentrations of JS212, JS207,toriplimab, or JS213	up to 2 years
ADA incidence	Incidence and titers of anti-drug antibodies (ADA) for JS212,JS207,toriplimab, or JS213; neutralizing antibodies (NAb) if applicable.	up to 4 years

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 11, 2028

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections; toripalimab
• Other Study ID Numbers: JS212-002-II-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No