Non-small Cell Lung Cancer
Conditions
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.
Interventions
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. 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. 4. 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. 5. According to the RECIST v1.1 criteria, the subject has at least 1 measurable lesion. 6. Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 7. Expected survival period ≥ 12 weeks. 8. The function of important organs meets the requirements of the protocol. 9. 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. 10. Voluntarily joining this study, signing the informed consent form, having good compliance, and cooperating with the follow-up.
Exclusion criteria
1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine (including small cell lung cancer and large cell neuroendocrine carcinoma) components. 2. Treatment received as listed in the protocol, including immunologically mediated treatment; drugs targeting the anti-VEGF pathway, etc. 3. Having an obvious bleeding tendency or a history of severe coagulation dysfunction. 4. 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. 5. Having a serious, unhealed or ruptured wound, active ulcer or untreated fracture. 6. Having uncontrolled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy. 7. 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). 8. Known allergy to the investigational drug or its excipients, pemetrexed, platinum drugs (carboplatin/cisplatin), or known history of ≥ grade 3 allergy to antibody drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed objective response rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Investigator-assessed Progression-Free Survival (PFS) | 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). |
| Investigator-assessed objective response rate (DCR) | 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). |
| Investigator-assessed overall survival (OS) | 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. |
| Adverse Event | 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. |
| Abnormal changes in laboratory | Up to approximately 25 months | Incidence and serverity of abnormal changes in laboratory and other tests with clinical significance |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity （Nab） | Up to approximately 25 months | The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable)，the titer of ADA |
| Expression level of PD-L1 in tumor tissues | 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 |
| Immunogenicity (ADA） | Up to approximately 25 months | The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA) |
| PK | Up to approximately 25 months | To characterize the trough concentrations of JS207 |
Countries
China
Contacts
Primary ContactYing Zhang, Master
Backup ContactHuiyu Lan, Master
Outcome results
None listed