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New treatment option for NSCLC Stage IV
Official title Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC
ClinicalTrials.gov ID: NCT04467723
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc stage iv.
Also referred to as Pirfenidone.
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
- The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.
- 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 and older
You may be able to join if
- Participant or legal representative is able to provide written informed prior to performing any protocol-related procedures
- Is willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study
- Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer
- Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
- Life expectancy of at least 6 months
You likely can't join if
- The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician's judgement...
- Has received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer, before the first dose...
- Has a known hypersensitivity to atezolizumab or pirfenidone
- Has active medical or psychiatric illness that would interfere with the study treatment
- Has uncontrolled diabetes
- Has any of the following cardiac diagnoses: Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left...
See the full eligibility criteria
- Participant or legal representative is able to provide written informed prior to performing any protocol-related procedures
- Is willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study
- Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer
- Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
- Life expectancy of at least 6 months
- De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR/ ALK/ ROS-1) that was previously treated with either PD-1 / PD-L1 or the combination of PD1/PDL1 and cytotoxic chemotherapy, no more than 2...
- At least 1 measurable lesion
- PDL1 TPS score less than 1% or unknown: first-line must be PD1/PDL1 inhibitor in combination with chemotherapy
- Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then PD1/PDL1 inhibitor treatment for recurrent disease
- Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease
- Eastern Cooperative Group (ECOG) Performance Status 0 - 2
- Is able to swallow oral medications
- Adequate hematologic function
- Adequate organ function
- The presence of any other concurrent severe and/or uncontrolled medical condition that would, in the investigator or treating physician's judgement, cause unacceptable safety risks, contraindicate patient participation...
- Has received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment
- Has a known hypersensitivity to atezolizumab or pirfenidone
- Has active medical or psychiatric illness that would interfere with the study treatment
- Has uncontrolled diabetes
- Has any of the following cardiac diagnoses: Unstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left ventricular ejection fraction \< 35%
- Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment
- Is pregnant or breast feeding
- Uncontrolled HIV
- Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3 months prior to registering for the study
- Has a history of idiopathic pneumonitis that required systemic agent including steroid
- Has drug-induced pneumonitis
- Has evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Smoker of more than 1 pack / day
- Has active peptic ulcer diagnosed within 4 weeks of enrollment
- Active infection requiring systemic treatment
- Current use of systemic antibacterial or antifungal agent
- Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of denosumab
- Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4 weeks earlier
- Concurrent use of other investigational agents
- Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires use of steroids
- Use of strong CYP1A2 inhibitors
- Previous history of cancer with active treatment within less than 1 year of enrollment
- Active auto-immune diseases
The study team makes the final eligibility decision.
Where it's taking place
- Fairway, Kansas, United States
- Kansas City, Kansas, 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 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairway, Kansas, United States; Kansas City, Kansas, 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.