RecruitingPhase 2NCT06412471

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


Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Enrollment

235 participants

Start Date

Jul 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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.
  • Signed informed consent form.

Exclusion Criteria5

  • 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.
  • 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.

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Interventions

DRUGSSGJ-707

bispecific antibody

DRUGcarboplatin

chemotherapy

DRUGPemetrexed

chemotherapy

DRUGpaclitaxel

chemotherapy

DRUGPD-1/L1

Immune checkpoint inhibitors

DRUGPaclitaxel-albumin

chemotherapy


Locations(1)

Institute of The Hunan Cancer Hospital

Changsha, China

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NCT06412471


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