JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
JS207
DrugJS207 (10 mg/kg or 15 mg/kg, IV, d1)
Pemetrexed injection
DrugPemetrexed (500 mg/m2 IV, D1)
Platinum
DrugPlatinum (carboplatin AUC 5, D1 or cisplatin 75 mg/m2, D1)
Paclitaxel
DrugPaclitaxel (175 mg/m2 IV, D1)
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: JS207+ Pemetrexed + a platinumExperimental treatment 3 interventions
Group B: JS207+ Paclitaxel + a platinumExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
Up to approximately 25 monthsSecondary outcomes
1
Investigator-assessed objective response rate (DCR)
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).
Time frame
Up to approximately 25 months2
Investigator-assessed Progression-Free Survival (PFS)
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).
Time frame
Up to approximately 25months3
Investigator-assessed overall survival (OS)
The OS is defined as the time from the first administration of the drug to death due to any cause.
Time frame
Up to approximately 30 months4
Adverse Event
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.
Time frame
Up to approximately 25 monthsOther outcomes
1
PK
To characterize the trough concentrations of JS207
Time frame
Up to approximately 25 months2
Immunogenicity (ADA）
The immunogenicity of JS207, including the incidence rate of anti-drug antibodies (ADA)
Time frame
Up to approximately 25 months3
Immunogenicity （Nab）
The immunogenicity of JS207, including the incidence rate of neutralizing antibodies (NAb) (if applicable)，the titer of ADA
Time frame
Up to approximately 25 months4
Expression level of PD-L1 in tumor tissues
Measuring the expression level of PD-L1 Protein in a Neoplasm tissue sample from a subject by an Immunohistochemistry assay
Time frame
Up to approximately 5 monthsSponsors and contacts
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Source ClinicalTrials.gov