JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC

NCT06969027 | Recruiting Phase 2

• 1 other identifier: JS207-010-II-NSCLC
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed objective response rate (ORR)

  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.

  Up to approximately 25 months

Secondary Outcomes (5)

• Investigator-assessed objective response rate (DCR)

  Up to approximately 25 months

• Investigator-assessed Progression-Free Survival (PFS)

  Up to approximately 25months

• Investigator-assessed overall survival (OS)

  Up to approximately 30 months

• Adverse Event

  Up to approximately 25 months

• Abnormal changes in laboratory

  Up to approximately 25 months

Other Outcomes (4)

• PK

  Up to approximately 25 months

• Immunogenicity (ADA）

  Up to approximately 25 months

• Immunogenicity （Nab）

  Up to approximately 25 months

Study Arms (2)

JS207+ Pemetrexed + a platinum

EXPERIMENTAL

Enrolling 30-42 Non-squamous non-small cell lung cancerparticipants，Patients will receive 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.

Drug: JS207; Drug: Pemetrexed injection; Drug: Platinum

JS207+ Paclitaxel + a platinum

EXPERIMENTAL

Enrolling 30-42 squamous non-small cell lung cancerparticipants，Patients will receive 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.

Drug: JS207; Drug: Platinum; Drug: Paclitaxel

Interventions

JS207 DRUG

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

JS207+ Paclitaxel + a platinum; JS207+ Pemetrexed + a platinum

Pemetrexed injection DRUG

Pemetrexed (500 mg/m2 IV, D1)

JS207+ Pemetrexed + a platinum

Platinum DRUG

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

JS207+ Paclitaxel + a platinum; JS207+ Pemetrexed + a platinum

Paclitaxel DRUG

Paclitaxel (175 mg/m2 IV, D1)

JS207+ Paclitaxel + a platinum

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Shandong First Medical University Affiliated Neoplasm Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Platinum; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Weihua Wang, Doctor

  Medical Director

  STUDY DIRECTOR

Central Study Contacts

Ying Zhang, Master

CONTACT

18616904609; ying_zhang2@junshipharma.com

Huiyu Lan, Master

CONTACT

15000239047; huiyu_lan@junshipharma.com

Study Design

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

Model Details: 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. 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.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 13, 2025
• Study Start: June 19, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)