Health TrialsbyHealthPanel

Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.

ConditionsLung CancerSurgeryNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

This phase II trial studies how well intra-tumor injection of double checkpoint inhibitors work when given alone and in combination with chemotherapy or/and bevacizumab in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab, pembrolizumab or durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in interventional radiological chemotherapy, such as idabubicin, can directly kill the cancer cell and release tumor antigens to activate DC function in situ. Giving intra-tumor injection of checkpoints inhibitors with or without chemotherapy and/or bevecizumab may work better than in vein infusion of the drugs in treating patients with non-small cell lung cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed previously untreated non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer are eligible, but pathology must be confirmed prior to initiating treatment on study.

Patients with stage IIIA must not have more than one mediastinal lymph node station involved by tumor.

All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease.

The patient must be a suitable candidate for surgery, in the opinion of the treating physician.

Disqualifiers

Prior systemic therapy or radiation therapy for treatment of the current lung cancer.

Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug.

Pregnant or lactating female.

Unwillingness or inability to follow the procedures required in the protocol.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab

    Drug

    This study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks, total 3-4 times. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks, total 3-4 times. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks, total 3-4 times.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group 1: IT injection of double ICIsExperimental treatment 1 intervention
Group B: Group 2: IT injection of double ICIs and chemodrugExperimental treatment 1 intervention
Group C: Group 3: IT injection of double ICIs and chemodrug plus bevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR rate for the study groups

Pathologic complete response (pCR) is defined as after neoadjuvant therapy, the surgical specimen can not find any residual cancer cells.

Time frame
Six months
2

mPR rate for the study groups

Major pathologic response (MPR) is defined as pathological less than 10% survival cancer cells after tumor resection.

Time frame
Six months

Secondary outcomes

1

Toxicity of the study groups

Toxicity is assessed by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.

Time frame
Six months
2

Response rates to neoadjuvant treatment

Recurrence-free survival is measured as routine.

Time frame
Six years
3

Overall survival

To correlate major pathologic response with recurrence-free and overall survival.

Time frame
Six years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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