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

NCT07309276 | Not Yet Recruiting Phase 2

• 1 other identifier: JS212-002-II-LC
• Study Type: interventional
• Target: 864
• Locations: 1 country
• Sites: 1

Brief 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. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.

Conditions

Advanced Lung Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

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

  up to 6 years

Secondary Outcomes (9)

• PFS

  up to 6 years

• DoR

  up to 6 years

• DCR

  up to 6 years

• OS

  up to 6 years

• Safety (AE)

  up to 6 years

Study Arms (3)

Queue 1: JS212 + JS207

EXPERIMENTAL

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; Drug: JS207 for Injection

Queue 2: JS212 + Toripalimab

EXPERIMENTAL

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; Drug: Toripalimab

Queue 3: JS212 + JS213

EXPERIMENTAL

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; Drug: JS213 for Injection

Interventions

JS207 for Injection DRUG

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

Queue 1: JS212 + JS207

Toripalimab DRUG

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

Queue 2: JS212 + Toripalimab

JS213 for Injection DRUG

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

Queue 3: JS212 + JS213

JS212 for Injection DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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;
• Unatable spinal cord compression;
• \. 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;

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Interventions

Injections; toripalimab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Weilong Ni, Master

CONTACT

18851101030; weilong_ni@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 11, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)