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New treatment option for Lung Cancer
Official title Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.
ClinicalTrials.gov ID: NCT06492421
What this study is testing
What is ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab?
ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer.
Also referred to as Other ICIs.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically or cytologically confirmed previously untreated non-small cell lung cancer. If a diagnostic biopsy is available, a pre-treatment...
- 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.
- Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference...
You likely can't join if
- 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.
- Patients with pre-existing sensorineural hearing impairment/loss or newly diagnosed as documented by an audiology assessment performed prior to study...
- Patients with a history of severe hypersensitivity reaction to taxotere and or polysorbate 80 must be excluded.
See the full eligibility criteria
- 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...
- 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.
- Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to...
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 100 x 10\^9/L; Total bilirubin =\ = 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine...
- 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.
- Patients with pre-existing sensorineural hearing impairment/loss or newly diagnosed as documented by an audiology assessment performed prior to study enrollment may not be eligible for cisplatin and may be dispositioned...
- Patients with a history of severe hypersensitivity reaction to taxotere and or polysorbate 80 must be excluded.
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive...
- people with active, known or suspected autoimmune disease. people with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or...
- Prior treatment with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody.
- Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid indicating acute or chronic infection.
- Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- History of severe hypersensitivity reaction to any monoclonal antibody and/or to study drug components.
- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or laboratory abnormality that may increase the risk associated with study participation or study drug...
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
- Allergic to contrast agent.
- Any agents which could affect the absorption or pharmacokinetics of the study drugs.
- Other conditions that investigator decides not suitable for the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guanzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.