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NCT Number: NCT06969027

JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC

This study targets patients with in first-line treatment of advanced NSCLC, enrolling 60-84 participants. Patients will receive Arm 1: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Pemetrexed (500 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1) + pemetrexed (500 mg/m2 IV, D1), Q3W, until meeting the treatment withdrawal criteria. Arm 2: JS207 (10 mg/kg or 15 mg/kg, IV, D1) + Paclitaxel (175 mg/m2 IV, D1) + a platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1), Q3W, for 4 cycles followed by JS207 (10 mg/kg or 15 mg/kg, IV, D1), Q3W, until meeting the treatment withdrawal criteria.The study aims to assess the safety, tolerability, and preliminary efficacy of JS207 combination therapy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shandong First Medical University Affiliated Neoplasm Hospital

Jinan, Shandong, 250117, China

Location status: Recruiting

Location contact

Jinming Yu, Ph.D

CONTACT

[email protected]

13806406293

Jinming Yu, Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years old (both 18 and 75 years old included) at the time of signing the informed consent form, applicable to both males and females.
  • Locally advanced (stage IIIB/IIIC), metastatic or recurrent non-small cell lung cancer (NSCLC) confirmed by histology or cytology, which is not eligible for radical surgery or radical chemoradiotherapy.
  • History of no systemic antitumor therapy for Metastatic or recurrent NSCLC; for subjects who have received adjuvant/neoadjuvant/consolidation therapy (Chemotherapy, radiotherapy, or other therapy), they can be enrolled if the interval between the last treatment and recurrence is more than 6 months.
  • Tissue samples are required for PD-L1 test. New tissue samples are preferred. If new tissue samples are not available, archived samples can be provided.
  • According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion.
  • Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
  • Expected survival period ≥ 12 weeks.
  • The function of important organs meets the requirements of the protocol.
  • Female subjects of childbearing potential, and male subjects whose partners are females of childbearing age, need to adopt a highly effective contraceptive measure during the study treatment period and for at least 6 months after the last administration.
  • Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.

Exclusion criteria

  • Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer and large cell neuroendocrine carcinoma) components.
  • Treatment received as listed in the protocol, including immunologically mediated treatment; drugs targeting the anti-VEGF pathway, etc.
  • Having an obvious bleeding tendency or a history of severe coagulation dysfunction.
  • Gastrointestinal perforation, intra-abdominal fistula or intra-abdominal abscess occurred within 6 months before the first administration, or currently having high-risk factors for perforation/fistula formation of the hollow viscus as judged by the investigator.
  • Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture.
  • Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
  • Expected that the toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE).
  • Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin/cisplatin), or known history of ≥ grade 3 allergy to antibody drugs

Treatment and study plan

JS207

Drug

JS207 (10 mg/kg or 15 mg/kg, IV, d1)

Pemetrexed injection

Drug

Pemetrexed (500 mg/m2 IV, D1)

Platinum

Drug

Platinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1)

paclitaxel

Drug

Paclitaxel (175 mg/m2 IV, D1)

Primary outcomes

  1. Investigator-assessed objective response rate (ORR)

    Time frame: Up to approximately 25 months

    Evaluate the investigator-assessed objective response rate (ORR) of JS207 combined with chemotherapy in the treatment of n first-line treatment of advanced non-small cell lung cancer (NSCLC) patients.The ORR is defined as the proportion of subjects who have a partial response (PR) or a complete response (CR) in the Best Overall Response.

Secondary outcomes

  1. Investigator-assessed objective response rate (DCR)

    Time frame: Up to approximately 25 months

    The DCR is defined as the proportion of subjects whose Best Overall Response (BOR) is Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

  2. Investigator-assessed Progression-Free Survival (PFS)

    Time frame: Up to approximately 25months

    The PFS is defined as the time from the first administration of the drug to the first documented disease progression (PD) according to the RECIST v1.1 criteria or death due to any disease (whichever occurs first).

  3. Investigator-assessed overall survival (OS)

    Time frame: Up to approximately 30 months

    The OS is defined as the time from the first administration of the drug to death due to any cause.

  4. Adverse Event

    Time frame: Up to approximately 25 months

    Collect Serious Adverse Events (SAEs) and Adverse Events (AEs) from the time of signing the Informed Consent Form (ICF) until the safety follow-up visit.Evaluate the safety of the investigational drug.

  5. Abnormal changes in laboratory

    Time frame: Up to approximately 25 months

    Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance

Other outcomes

  1. PK

    Time frame: Up to approximately 25 months

    To characterize the trough concentrations of JS207

  2. Immunogenicity (ADA)

    Time frame: Up to approximately 25 months

    The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA)

  3. Immunogenicity (Nab)

    Time frame: Up to approximately 25 months

    The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable),the titer of ADA

  4. Expression level of PD-L1 in tumor tissues

    Time frame: Up to approximately 5 months

    Measuring the expression level of PD-L1 Protein in a Neoplasm tissue sample from a subject by an Immunohistochemistry assay

Study contacts

Contact information is provided by the study sponsor or research team.

Huiyu Lan, Master

CONTACT

[email protected]

15000239047

Ying Zhang, Master

CONTACT

[email protected]

18616904609

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study title

JS207 (PD-1/VEGF Dual Antibody) Combined With Chemotherapy in First-line Treatment of Advanced Non-small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
May 13, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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