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A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients

ConditionFirst-line Advanced NSCLC Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and/or females over age 18

Histologically and/or cytologically documented local advanced or metastatic NSCLC .

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Expected survival >=3 months.

Disqualifiers

Known uncontrolled or symptomatic central nervous system metastatic disease.

Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).

Inadequate organ or bone marrow function.

Pregnant or breast-feeding woman.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SSGJ-706

    Drug

    PD-1/PD-L1 bispecific antibody

  • pemetrexed /carboplatin

    Drug

    chemotherapy

  • Carboplatin/Paclitaxel

    Drug

    chemotherapy

  • PD-1 Inhibitor + Chemotherapy

    Drug

    control group

Treatment groups

240 Participants
are divided into 5 treatment groups
Group A: dose level 1 of SSGJ-706 monotherapyExperimental treatment 1 intervention
Group B: dose level 2 of SSGJ-706 monotherapyExperimental treatment 1 intervention
Group C: dose level 1 of SSGJ-706 combined with chemotherapyExperimental treatment 2 interventions
Group D: dose level 2 of SSGJ-706 combined with chemotherapyExperimental treatment 2 interventions
Group E: PD-1/L1 combined with chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
12 months
2

Incidence and severity of Adverse Events

Time frame
12 months

Secondary outcomes

1

DCR : Disease Control Rate

Time frame
12 months
2

PFS：Progression-Free Survival

Time frame
24 month
3

OS：Overall Survival

Time frame
24 month
4

The blood concentration of SSGJ-706

Time frame
Approximately 6 months

Other outcomes

Sponsors and contacts

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

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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