JS207 Combined With Chemotherapy in Subjects With Stage II-III NSCLC
ConditionNSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.
About this trial
This is a phase II clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics of JS207 (anti-PD-1/VEGF bispecific antibody) combined with platinum-based doublet chemotherapy in subjects with stage II-III non-small cell lung cancer. The study consists of 2 cohorts, including treatment-naïve and resectable subjects with stage II-III NSCLC (cohort 1), treatment-naïve and unresectalbe subjects with stage III NSCLC (cohort 2). Subjects in both cohorts will receive 3 cycles of JS207 + platinum-based doublet chemotherapy as neoadjuvant therapy, followed by surgery or definitive chemoradiotherapy, and then adjuvant therapy with JS207 (post-surgery) or consolidation therapy with JS207 (post-chemoradiotherapy).
Eligibility criteria
Qualifiers
Age 18 to 75 years at the time of signing the informed consent (inclusive of 18 and 75 years), either gender.
Histologically confirmed, previously untreated stage II-III NSCLC (AJCC 8th edition), cTNM stage can be confirmed by PET-CT or pathological biopsy. For suspicious lesions that are suspected by imaging examination, which can lead to changes in TNM stage, including but not limited to contralateral mediastinal lymph nodes and supraclavicular lymph nodes, pathological biopsy verification is strongly recommended.
Cohort 1: Subjects with resectable, stage II, IIIA, or IIIB (N2) NSCLC evaluated by MDT.
Cohort 2: Subjects with unresectable, stage III NSCLC evaluated by MDT.
Disqualifiers
Histopathologically or cytologically confirmed combined components of neuroendocrine tumours (including small cell lung cancer, large cell neuroendocrine carcinoma, etc.) and Pancoast tumor.
Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Any clinically significant hemoptysis (≥2.5 ml) or Tumour haemorrhage of any cause within one month before the first use of the study drug.
Previous systemic antitumor therapy for NSCLC (including investigational drugs), such as chemotherapy or immunologically mediated therapy (including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA-4 therapy) and anti-angiogenic therapy (such as anti-VEGF pathway-targeted drugs);
Trial design
Treatments tested in this trial
- Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma
- surgery
- Radiochemotherapy
- JS207
Treatment groups
76 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov