Combining a new vaccine with immunotherapy for advanced lung cancer resistant to treatment

Single-arm, Open, Prospective Clinical Study of Neoantigen-loaded Dendritic Cell Vaccine (Neo-DCVac) Combined With Immune Checkpoint Inhibitors (ICIs) in the Treatment of Advanced Lung Cancer Resistant to ICIs

This study is testing a new vaccine combined with existing immune treatments to see if it can help people with advanced lung cancer who haven't responded to previous therapies.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sichuan University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06329908 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of a novel vaccine, Neo-DCVac, combined with immune checkpoint inhibitors (ICIs) for patients with advanced lung cancer who have developed resistance to prior ICI treatments. The study involves screening patients who have undergone first-line PD-1 immunotherapy, extracting tumor tissues for neoantigen prediction, and administering a bridging therapy with docetaxel while the vaccine is prepared. Following successful vaccine preparation, patients will receive the vaccine alongside ICIs, with efficacy assessed after the completion of the immunization course. Treatment will continue based on tumor response until disease progression or severe intolerance occurs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with advanced non-small cell lung cancer who have previously received PD-1 immunotherapy and developed resistance.

Not a fit: Patients with early-stage lung cancer or those who have not previously received immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced lung cancer who have become resistant to existing immunotherapies.

How similar studies have performed: Other studies have shown promise in combining vaccines with immunotherapy for cancer treatment, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

* Aged 18-85 years.
* ECOG score was 0-2.
* Histological or cytological diagnosis confirmed non-small cell lung cancer, which was staged IIIB-IV according to AJCC version 8.
* Patients have received first-line chemotherapy combined with ICIs (PD1/PD-L1, ICIs type is not limited) and developed drug resistance.
* Normal function of major organs, that is, meeting the following criteria: a) blood routine examination (hematopoietic growth factors and blood transfusion were not used within 7 days): granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥ 80 g/L; b) biochemical examination: total bilirubin ≤ 1.5 × ULN (upper limit of normal); serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) coagulation function: INR or PT ≤ 1.5 × ULN (upper limit of normal), if the subject is receiving anticoagulant therapy, as long as PT is in the range proposed by anticoagulant drugs; d) urine routine examination: urine routine examination urine protein ≥ 2 +, 24-hour urine protein quantitative examination should be performed, such as quantitative urine protein ≤ 1 g/24 h.
* Female subjects of childbearing age or male subjects with sexual partners of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months before and after the treatment period.
* Subjects voluntarily participate in the study and sign the informed consent form

Exclusion Criteria:

* The pathological type is mixed type, containing small cell carcinoma or other types of components.
* with the blood-borne infectious disease HIV.
* History of mental disorder, drug abuse and drug abuse.
* Any other malignancy (except completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer) within 3 years.
* Accompanied by other immune diseases, or long-term use of immunosuppressive agents or hormones.
* Any unstable systemic disease (including active uncontrolled gastrointestinal ulcers, gastric obstruction, bleeding risk or coagulopathy, active infection, for subjects with hepatitis B, anti-hepatitis B 11 virus treatment is required during study treatment, active hepatitis C subjects (HCV antibody positive and HCV- RNA levels above the lower limit of detection, grade IV hypertension, unstable angina pectoris, congestive heart failure, myocarditis, unstable cerebrovascular disease, thrombotic disease, liver, kidney, uncontrolled metabolic disease or unhealed fractures, wounds as judged by the surgeon).
* Presence of active central nervous system (CNS) metastases; subjects with previously treated brain metastases (e.g., surgery, radiotherapy, hormone therapy) are allowed if clinically stable for at least two weeks after treatment from the first dose of study drug and corticosteroids are discontinued 7 days before study drug administration; untreated, asymptomatic subjects with brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no significant edema around the brain metastases) can be enrolled.
* Any anti-tumor therapy including chemotherapy, radiotherapy, and targeted therapy within 3 weeks prior to the first dose of study drug.
* Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring drainage.
* Previous use of anti-tumor vaccines, live vaccines within 30 days.
* Patients are difficult to communicate or to follow up for a long time. Pregnant or lactating women.
* Current or planned participation in other clinical trials.
* Dr. finds other unsuitable situations

Where this trial is running

Chengdu, Sichuan

• West China Hospital — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Zhengyu Ding, MD

Conditions: Lung Cancer, Criteria for inclusion