SSGJ-706 alone and combined with chemotherapy or PD-1 inhibitors for advanced non-small cell lung cancer

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

This trial tests whether SSGJ-706 by itself or with chemotherapy and a PD-1 inhibitor can help adults with first-line advanced non-small cell lung cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07171606 on ClinicalTrials.gov

What this trial studies

This Phase II trial enrolls adults with first-line advanced or metastatic NSCLC and has two parts: part 1 explores SSGJ-706 monotherapy across several preset dose levels, and part 2 tests SSGJ-706 combined with standard chemotherapy regimens and a PD-1 inhibitor. Each part measures tumor response and safety to identify active dose(s) and tolerability. Eligible participants must have ECOG 0–1, adequate organ and bone marrow function, and no uncontrolled symptomatic central nervous system metastases. The sponsor is Shenyang Sunshine Pharmaceutical and the trial is conducted at Shanghai Pulmonary Hospital.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed first-line advanced or metastatic NSCLC, ECOG performance status 0–1, expected survival ≥3 months, adequate organ function, and no uncontrolled CNS metastases or known allergy to SSGJ-706.

Not a fit: Patients with uncontrolled or symptomatic brain metastases, significant organ or marrow dysfunction, recent high‑grade toxicity from prior anticancer therapy, pregnancy or breastfeeding, or known hypersensitivity to SSGJ-706 are unlikely to qualify or benefit.

Why it matters

Potential benefit: If effective, SSGJ-706 could shrink tumors, delay disease progression, or improve responses when given alone or with standard chemotherapy and immunotherapy.

How similar studies have performed: Other trials combining targeted agents with chemotherapy or PD-1 inhibitors have benefited selected NSCLC groups, but SSGJ-706 appears to be a novel agent without large published efficacy data yet.

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-706

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

Shanghai

• Institute of The Shanghai Pulmonary Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Shengxiang Ren

Conditions First-line Advanced NSCLC Patients