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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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Paclitaxel + Carboplatin/cisplatin for squamous cell carcinoma and pemetrexed + carboplatin/cisplatin for non-squamous cell carcinoma

    Drug

    Carboplatin Injection: One dose of carboplatin AUC 5 IV on Day 1 of each 3-week cycle. Cisplatin injection: Cisplatin 75 mg/m2 IV on Day 1 of every 3-week cycle. Paclitaxel injection: 175 mg/m2 IV on Day 1 of each 3-week cycle. Pemetrexed Injection: Pemetrexed 500 mg/m2 IV on Day 1 of each 3-week cycle.

  • surgery

    Procedure/Surgery

    Subjects with surgical indications will undergo radical surgery for NSCLC，within 4-6 weeks after the last dose of neoadjuvant therapy.

  • Radiochemotherapy

    Radiation

    If radical surgery is not suitable after MDT evaluation, the subjects will receive comprehensive treatment mainly based on radiotherapy.

  • JS207

    Drug

    JS207 will be administered every 3 weeks for a treatment cycle of 21 days.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Cohort1：enrolled untreated resectable stage II-III NSCLC patients（JS207）Experimental treatment 3 interventions
Group B: Cohort2：enrolled untreated, stage III NSCLC patients（JS207）Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

PCR rate

To evaluate the pathologic complete response rate (pCR rate) of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.

Time frame
2 years

Secondary outcomes

1

MPR rate

To evaluate the pathologic MPR rate of JS207 combined with platinum-based doublet chemotherapy in subjects with resectable stage II-III NSCLC and subjects with uresectable stage III NSCLC.

Time frame
2 years
2

EFS

Time from the beginning of randomization until disease progression under the RECIST1.1 criteria is first recorded leading to inoperable or CRT, local progression leading to inoperable tumor resection or CRT, CRT or postoperative disease recurrence or progression, or death from any cause, whichever occurs first

Time frame
2 years
3

ORR

Subjects with partial response (PR) or complete response (CR) at BOR

Time frame
2 years
4

DCR

Proportion of subjects with CR, PR, or stable disease (SD) at BOR

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Junshi Bioscience Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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