Combination therapy for inoperable lung cancer using intra-tumor injections

Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and/or Bevacizumab Therapy as First Line for Inoperable Lung Cancer

This study is testing a new way to treat inoperable lung cancer by combining special injections with chemotherapy to see if it helps patients live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (Academic / other)
• Drugs / interventions: bevacizumab, ipilimumab, pembrolizumab, durvalumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06483347 on ClinicalTrials.gov

What this trial studies

This trial investigates the safety and effectiveness of combining checkpoint inhibitors ipilimumab with either pembrolizumab or durvalumab, along with chemotherapy or bevacizumab, delivered directly into tumors for patients with inoperable lung cancer. The approach aims to enhance local drug concentration while minimizing systemic side effects. The study will assess various outcomes, including progression-free survival and overall response rates, to determine the potential benefits of this innovative treatment method. It is a Phase II trial, focusing on patients who have not received prior treatment for their lung cancer.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with confirmed inoperable lung cancer and a life expectancy of more than three months.

Not a fit: Patients with severe liver dysfunction, active bleeding, or those who have participated in other clinical trials within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new first-line treatment option for patients with inoperable lung cancer, potentially improving survival rates and quality of life.

How similar studies have performed: While the use of checkpoint inhibitors has been successful in various cancers, this specific approach of intra-tumor delivery combined with double checkpoint inhibitors is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

1. Cytohistological confirmation is required for diagnosis of cancer.
2. Signed informed consent before recruiting.
3. Age above 18 years with estimated survival over 3 months.
4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2
5. Tolerable coagulation function or reversible coagulation disorders
6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L
7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
8. Birth control.
9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria:

1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;
3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
4. Patients accompanied with other tumors or past medical history of malignancy;
5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
6. Patients have poor compliance.

   Any contraindications for hepatic arterial infusion procedure:

   A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).

   B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
7. Allergic to contrast agent;
8. Any agents which could affect the absorption or pharmacokinetics of the study drugs
9. Other conditions that investigator decides not suitable for the trial.

Where this trial is running

Guangzhou, Guangdong

• Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD, PhD

Conditions Lung Cancer; Inoperable Disease; Inoperable lung cancer; Intra-tumor injection; Immunotherapy; First line therapy