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A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer

ConditionAdvanced Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Junshi Bioscience Co., Ltd.

About this trial

This is a multicenter, open-label Phase II clinical study, with the main objective being to evaluate the investigator-assessed objective response rate of JS212 in combination therapy for advanced lung cancer. The aim is to explore the safety, tolerability, and preliminary efficacy of JS212 combined with JS207, Toripalimab, JS213 combined or not combined with chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age between 18 and 75 years old, and any gender.

Local advanced, metastatic or recurrent NSCLC.

ES-SCLC.

According to the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), there must be at least one measurable lesion.

Disqualifiers

Tumor histological or cytological pathological confirmation of combined large cell neuroendocrine carcinoma or sarcomatoid lesion, or NSCLC with small cell lung cancer component;

NSCLC patients with positive driver mutations;

Patients with known meningeal metastasis;

Patients with symptomatic brain metastases;

Trial design

Design model

Single group

Treatments tested in this trial

  • JS212 for Injection

    Drug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS207 for Injection

    Drug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • Toripalimab

    Drug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

  • JS213 for Injection

    Drug

    Administered by intravenous infusion on Day 1 of each 21-day cycle.

Treatment groups

864 Participants
are divided into 3 treatment groups
Group A: Queue 1: JS212 + JS207Experimental treatment 2 interventions
Group B: Queue 2: JS212 + ToripalimabExperimental treatment 2 interventions
Group C: Queue 3: JS212 + JS213Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR

Objective response rate(ORR), assessed by BICR (RECIST v1.1)

Time frame
up to 6 years

Secondary outcomes

1

PFS

Progression-free survival (PFS), assessed by investigators (RECIST v1.1)

Time frame
up to 6 years
2

DoR

Duration of response (DoR), assessed by BICR and investigators

Time frame
up to 6 years
3

DCR

Disease control rate (DCR), assessed by BICR and investigators

Time frame
up to 6 years
4

OS

overall survival (OS)

Time frame
up to 6 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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