Combination therapy for advanced lung cancer patients

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

This study is testing a new combination treatment for people with advanced lung cancer to see how well it works and if it's safe.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (industry)
• Locations: 1 site (Changsha)
• Trial ID: NCT06412471 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of SSGJ-707 combination therapy in patients with advanced non-small cell lung cancer (NSCLC). It consists of two parts: part A focuses on non-squamous NSCLC, while part B targets squamous NSCLC. Participants will receive various doses of SSGJ-707 along with standard treatments such as carboplatin, pemetrexed, and paclitaxel. The study aims to determine the optimal dosing and therapeutic outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced or metastatic NSCLC and an ECOG performance status of 0-1.

Not a fit: Patients with uncontrolled central nervous system metastases or significant adverse reactions to previous cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new effective treatment option for patients with advanced NSCLC.

How similar studies have performed: Other studies have shown promise with combination therapies in NSCLC, suggesting potential for success with this approach.

Eligibility 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.

Where this trial is running

Changsha

• Institute of The Hunan Cancer Hospital — Changsha, China (RECRUITING)

Study contacts

• Study coordinator: Lin Wu, MD, Ph.D

Conditions: First-line Advanced NSCLC Patients