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A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06412471
Enrollment
235
Registered
2024-05-14
Start date
2024-07-26
Completion date
2025-08-31
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First-line Advanced NSCLC Patients

Brief summary

This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

Detailed description

This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Interventions

DRUGSSGJ-707

bispecific antibody

DRUGcarboplatin

chemotherapy

DRUGPemetrexed

chemotherapy

DRUGpaclitaxel

chemotherapy

DRUGPD-1/L1

Immune checkpoint inhibitors

DRUGPaclitaxel-albumin

chemotherapy

Sponsors

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or metastatic NSCLC . 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>=3 months. 5. Signed informed consent form.

Exclusion criteria

1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. 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). 3. Inadequate organ or bone marrow function. 4. Pregnant or breast-feeding woman. 5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Design outcomes

Primary

MeasureTime frameDescription
ORR12 monthsObjective response rate
Safety and tolerability12 monthsSafety and tolerability assessed by incidence and severity of adverse events

Secondary

MeasureTime frameDescription
PFS24 monthsThe efficacy end points

Countries

China

Contacts

Primary ContactLin Wu, MD, Ph.D
wulin-calf@vip.163.com0731-89762302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026