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NCT06412471 | RECRUITING | First-line Advanced NSCLC Patients

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

sunshine GU Okey pharmaceutical (Shanghai) co., Ltd.

Brief Summary:

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

Condition or disease

First-line Advanced NSCLC Patients

Intervention/treatment

SSGJ-707

carboplatin

Pemetrexed

paclitaxel

PD-1/L1

Paclitaxel-albumin

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 235 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients
Actual Study Start Date : 2024-07-26
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

Location Details

NCT06412471

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China,

Institute of The Hunan Cancer Hospital

Changsha, China,