Nutritional therapy combined with chemotherapy for advanced lung cancer

A Single-center, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Tumor Nutritional Therapy Combined With Immune Checkpoint Inhibitors and Chemotherapy in the First-line Treatment of Stage IV NSCLC Without Driver Gene Mutations

This study is testing whether adding a special nutritional therapy to chemotherapy can help people with advanced lung cancer feel better and improve their treatment results.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Dalian Medical University (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Dalian City, Liaoning)
• Trial ID: NCT06356701 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a nutritional therapy regimen alongside immune checkpoint inhibitors and chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC) that lacks specific driver gene mutations. The nutritional regimen includes Spirulina Bifidobacterium Capsules, Fish Oil Grape Seed Blueberry Soft Capsules, and Ganoderma Spore Oil Soft Capsules. The study aims to assess not only the treatment's effectiveness but also its safety and the relationship between T cell subpopulations and inflammatory factors during treatment. This is a single-center, randomized, controlled trial designed to provide insights into the potential benefits of nutritional support in cancer therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with stage IV NSCLC without driver gene mutations and an ECOG performance status of 0-2.

Not a fit: Patients with known driver gene mutations or those with a poor prognosis (ECOG > 2) may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients with advanced lung cancer by improving their response to standard therapies.

How similar studies have performed: While there is ongoing research into nutritional therapies in cancer treatment, this specific combination approach is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Voluntary participation in this clinical study
* Fully understand and know this research and sign the informed consent form.
* Be 18-75 years old (inclusive) on the day of signing ICF.
* Stage IV non-small cell lung cancer first diagnosed by histology or cytology. There is no known epidermal growth factor receptor (EGFR) sensitive mutation, anaplasticlymphomakinase (ALK) gene rearrangement and ros sarcoma oncogenic factor 1- receptor tyrosine kinase (ROS1) gene fusion.
* The physical condition of 4.ECOG is 0-2, and the expected survival time is more than three months
* It must have measurable target lesions judged by researchers according to RECIST v1.1.
* Subjects should provide tumor tissue samples collected at or after the diagnosis of stage IV NSCLC, which are fixed by formalin and can be used to determine the expression level of PD-L1.
* Subjects must have sufficient organ function, which is evaluated according to the following laboratory examination results (and have not received medical support treatment such as blood transfusion, infusion of apheresis components, erythropoietin and granulocyte colony stimulating factor within 14 days before the administration of the study drug):
* Except for hearing loss, alopecia and fatigue, all toxicity caused by previous anti-tumor treatments must have been restored to ≤ 1 grade.
* Fertile women must have a serum pregnancy test within 7 days before the first medication, and the result is negative.
* No obvious heart disease, no myocardial infarction in the past 6 months. Obvious congestive heart failure, obvious supraventricular arrhythmia, conduction block above grade II, acute myocardial ischemia or prolonged QT interval.
* No antibiotics, probiotic foods or microecological agents were used in the first two weeks.

Exclusion Criteria:

* Histologically identified as small cell lung cancer or with small cell components
* Active or untreated central nervous system metastasis and/or cancerous meningitis.
* Received major surgery except diagnostic biopsy within 4 weeks before the first medication, and received radical radiotherapy within 6 months before medication.
* People with active autoimmune diseases, or those who have suffered from autoimmune diseases and are likely to recur.
* Currently receiving systemic hormone therapy or using any other form of immunosuppressive therapy within 14 days before the first administration.
* Other primary malignant tumors have appeared in the past five years, except for locally curable malignant tumors after radical treatment.
* Have received any antibody/drug (including PD-1, PD-L1, CTLA4, TIM3, LAG3, etc.) targeting T cell co-regulatory proteins (immune checkpoints).
* Suffering from interstitial lung disease, or having a history of interstitial lung disease in the past and needing hormone therapy
* Previous history of idiopathic pulmonary fibrosis, drug-induced pneumonia, organized pneumonia and idiopathic pneumonia
* Or those with active pneumonia proved by chest CT in screening period.
* Received live vaccine inoculation within 28 days before the first drug administration.
* Participated in other clinical research trials within 28 days before the first administration of the research drug, and received research drug treatment or used research equipment.
* Chinese medicines with anti-tumor indications have been used within 14 days before the first administration of the study drug.
* Have a history of inflammatory enteritis or have inflammatory bowel disease (such as Crohn's disease and ulcerative colitis).
* There are serious acute and chronic infections.
* Pleural effusion or pericardial effusion that cannot be controlled after appropriate intervention, or ascites that needs repeated drainage (once a month or more frequently).
* Known history of alcoholism or drug abuse.
* Pregnant or lactating women.
* Have a history of drug allergy, such as pemetrexed, carboplatin, carboplatin or other platinum compounds, or their preventive drugs
* Have an allergic history to paclitaxel or protein-bound paclitaxel components
* Or asthma is not controlled.
* Suffering from major cardiovascular diseases
* Acute myocardial infarction, unstable angina pectoris, stroke and transient ischemic attack occurred in the first 6 months
* Suffering from congestive heart failure (NYHA≥2)
* Severe arrhythmia requiring medical treatment.
* The researcher thinks that the subject's complications or other circumstances may affect the compliance with the protocol or be unsuitable for participating in this study.

Where this trial is running

Dalian City, Liaoning

• DongYan — Dalian City, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: DongYan Dong

Conditions Long-Term Effects Secondary to Cancer Therapy; lung cancer; Effect of nutritional therapy