JS212 in Combination With JS111 as First-Line Treatment in EGFR-Mutant Advanced NSCLC

NCT07714304 | Not Yet Recruiting

• 1 other identifier: NSCLC-IIT-JS212-F01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single-arm clinical study evaluating the safety, tolerability, and preliminary efficacy of JS212 in combination with JS111 as first-line treatment in participants with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for advanced disease. The study consists of a safety lead-in stage followed by a clinical expansion stage. Approximately 20 participants are planned to be enrolled across the two stages. Participants will receive JS212 by intravenous infusion on Day 1 of each 21-day cycle and JS111 at 160 mg orally once daily until treatment discontinuation criteria are met. During the safety lead-in stage, up to 10 participants will be enrolled and monitored for significant toxicities during the first 21 days after initial administration. The Safety Monitoring Committee (SMC) will review available safety, tolerability, and efficacy data and determine the JS212 dose to be further evaluated, whether an additional higher or lower dose should be explored, and whether the study may proceed to the clinical expansion stage.

Conditions

NSCLC Harboring EGFR Mutations

Outcome Measures

Primary Outcomes (2)

• ORR

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

  up to 3 years

• Safety (AE)

  Incidence and severity of adverse events (AEs), and abnormal laboratory or clinical findings.

  up to 6 years

Secondary Outcomes (4)

• PFS

  up to 6 years

• DoR

  up to 6 years

• DCR

  up to 6 years

• OS

  up to 6 years

Study Arms (1)

JS212 for Injection + JS111 capsules (AP-L1898)

EXPERIMENTAL

JS212：JS212 will be administered by intravenous infusion on Day 1 of each 21-day cycle. JS111：160 mg once daily (QD)

Drug: JS212 for Injection; Drug: JS111 capsules (AP-L1898)

Interventions

JS111 capsules (AP-L1898) DRUG

160 mg once daily (QD)

JS212 for Injection + JS111 capsules (AP-L1898)

JS212 for Injection DRUG

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

JS212 for Injection + JS111 capsules (AP-L1898)

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria to be eligible for enrollment in this study:
• Male or female participants aged 18 to 75 years, inclusive, at the time of signing the informed consent form.
• Histologically or cytologically confirmed recurrent or metastatic solid tumor that is unresectable and not amenable to curative radiotherapy or chemoradiotherapy.
• Confirmed EGFR-sensitizing mutation, defined as an exon 19 deletion or L858R mutation, either occurring alone or together with other EGFR mutations, including concomitant T790M mutation. Local laboratory test reports are acceptable, provided that testing is performed using a well-validated assay, an assay that has passed external quality assessment, a laboratory qualified for molecular pathology diagnosis or genetic testing, or an assay approved by the National Medical Products Administration (NMPA). Participants must not have received prior systemic antitumor therapy for locally advanced or metastatic nonsquamous NSCLC. Participants with recurrent NSCLC who previously received adjuvant or neoadjuvant therapy, including chemotherapy, radiotherapy, or other treatment, or definitive radiotherapy or chemoradiotherapy, may be enrolled if the interval between the last treatment and disease recurrence is more than 6 months.
• At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Life expectancy of at least 12 weeks.
• Adequate major organ function.
• Women of childbearing potential (WOCBP) who are sexually active with a nonsterilized male partner must have a negative serum pregnancy test within 7 days before the first dose and must agree to have no plans for pregnancy and to use highly effective contraception from the time of signing the informed consent form until 7 months after the last dose of JS212 or 2 months after the last dose of JS111, whichever contraception period is longer.
• Nonsterilized male participants who are sexually active with a female partner of childbearing potential must agree to use effective contraception, as described in Appendix 2, from the time of signing the informed consent form until 4 months after the last dose of JS212 or JS111. Sperm donation is prohibited during this period.
• The participant voluntarily agrees to participate in the study and signs the informed consent form.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• \. Any of the following disease-related conditions:
• Histologically or cytologically confirmed tumor containing a small-cell lung cancer component, large-cell neuroendocrine carcinoma, sarcomatoid features, or a squamous cell carcinoma component greater than 10%;
• Known leptomeningeal metastases;
• Symptomatic brain parenchymal metastases. Participants with asymptomatic brain metastases may be enrolled if considered stable by the investigator.
• Uncontrolled pleural effusion or pericardial effusion, or ascites requiring repeated drainage once per month or more frequently;
• Spinal cord compression not treated with surgery and/or radiotherapy, or previously diagnosed spinal cord compression without clinical evidence of disease stability for at least 4 weeks before enrollment following treatment.
• \. Receipt of any of the following treatments:
• Chemotherapy or other systemic antitumor therapy within 3 weeks or 5 half-lives before the first dose, whichever is shorter; small-molecule targeted therapy within 2 weeks before the first dose; or limited-field local radiotherapy, such as palliative radiotherapy for bone metastases, within 2 weeks before the first dose;
• Use of a strong CYP3A inhibitor or inducer within 14 days before the first dose of study treatment, or anticipated need for continued treatment with such medications during the study;
• Current treatment with medications known to prolong the QT interval or potentially cause torsades de pointes, or anticipated need for continued treatment with such medications during the study;
• Receipt of any investigational drug within 4 weeks or 5 half-lives before the first dose of study treatment, whichever is shorter;
• Concurrent enrollment in another clinical study, unless it is an observational, noninterventional study or the participant is in the follow-up phase of an interventional clinical study;
• Major surgery, such as craniotomy, thoracotomy, or laparotomy, within 4 weeks before the first dose of study treatment;
• Prior treatment with any EGFR tyrosine kinase inhibitor, any antibody-drug conjugate with a topoisomerase I inhibitor payload, or any antibody and/or antibody-drug conjugate targeting EGFR and/or HER3;

Sponsors & Collaborators

• Huan Zhou: lead

Study Sites (2)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230088, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

kui Zhang

CONTACT

+8618168028925; kui_zhang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): July 23, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)