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New treatment option for Advanced Lung Non-Small Cell Carcinoma
Official title Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
ClinicalTrials.gov ID: NCT06731270
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced lung non-small cell carcinoma.
Also referred to as MPDL 3280A, MPDL 328OA.
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 tests how well diclofenac works in treating patients non-small cell lung cancer (NSCLC) that may have spread from where it first started (primary site) to other places in the body (metastatic) on single agent immunotherapy. Diclofenac, a type of non-steroidal anti-inflammatory (NSAID), blocks the body's production of a substance that causes inflammation and may decrease tumor growth and improve the effectiveness of immunotherapy.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Capable of signing informed consent
- Age ≥ 18 years at time of study entry
- Stage III or IV pathologically proven NSCLC with advanced or metastatic disease, currently on treatment with an Food and Drug Administration (FDA)...
- May include frontline single agent immune checkpoint inhibitors (ICI), maintenance single agent ICI after chemo-ICI, or subsequent line therapy
- Radiographic evidence of clinical progression as determined by the treating physician, not warranting immediate change of therapy. Progressive...
You likely can't join if
- Concurrent enrollment in another clinical study, unless it is non-therapeutic
- Prophylactic or therapeutic anticoagulation therapy including but not limited to: warfarin, heparin, low molecular weight heparin, or direct oral...
- Treatment within the previous 6 weeks or planned initiation of bevacizumab
- Abnormal markers of coagulation as measured by international normalized ratio (INR) \> 2
- Contraindication for NSAID therapy including: chronic aspirin therapy for coronary artery disease (CAD), cerebrovascular accident (CVA), or other...
- Female of childbearing potential unwilling or unable to use 2 methods of contraception, detailed in protocol
See the full eligibility criteria
- Capable of signing informed consent
- Age ≥ 18 years at time of study entry
- Stage III or IV pathologically proven NSCLC with advanced or metastatic disease, currently on treatment with an Food and Drug Administration (FDA) approved single agent monoclonal antibody inhibiting the PD(L)-1 pathway...
- May include frontline single agent immune checkpoint inhibitors (ICI), maintenance single agent ICI after chemo-ICI, or subsequent line therapy
- Radiographic evidence of clinical progression as determined by the treating physician, not warranting immediate change of therapy. Progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is...
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of ≥ 26 weeks
- Absolute neutrophil count (ANC) ≥ 1,000 cell/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8 gm/dL
- Creatinine clearance ≥ 45 ml/ml
- Bilirubin ≤ 1.5 x institutional upper limit of normal
- Bilirubin must be ≤ 3 x institutional upper limit of normal in patients with documented Gilbert's syndrome
- Serum glutamic oxaloacetic transaminase (SGOT) / serum gluatmic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal
- Ability to take oral medications
- Willingness and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- Concurrent enrollment in another clinical study, unless it is non-therapeutic
- Prophylactic or therapeutic anticoagulation therapy including but not limited to: warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants, including: dabigatran (Pradaxa), rivaroxaban (Xarelto)...
- Treatment within the previous 6 weeks or planned initiation of bevacizumab
- Abnormal markers of coagulation as measured by international normalized ratio (INR) \> 2
- Contraindication for NSAID therapy including: chronic aspirin therapy for coronary artery disease (CAD), cerebrovascular accident (CVA), or other indication, uncontrolled gastrointestinal ulcerative disease, known...
- Female of childbearing potential unwilling or unable to use 2 methods of contraception, detailed in protocol
- Uncontrolled intercurrent illness
- History of another primary malignancy with exceptions noted in protocol
- History of active primary immunodeficiency or active infection including tuberculosis, hepatitis B, hepatitis C
- Current or prior use of immunosuppressive medication within 14 days before the first dose of diclofenac. There are exceptions to this criterion
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study medications
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. 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.