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Chemotherapy
Chemo-Immunotherapy for Non-Small Cell Lung Cancer (STAGGER Trial)
Phase 2
Recruiting
Led By Wallace Akerley, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status ≤ 2
Histologically or cytologically confirmed metastatic non-squamous non-small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
STAGGER Trial Summary
This trial will test the effectiveness of a new cancer treatment combining durvalumab with pemetrexed and carboplatin.
Who is the study for?
Adults with metastatic non-squamous non-small cell lung cancer who haven't had chemoimmunotherapy can join this trial. They must be willing to use effective birth control and follow the study's protocol, including visits and exams. People with certain health conditions or those on immunosuppressive medications (except some steroids) are excluded.Check my eligibility
What is being tested?
The trial is testing two staggered dosing regimens of Durvalumab combined with Pemetrexed and Carboplatin in patients. It aims to determine which regimen is more effective for treating advanced lung cancer in a Phase II open label, randomized setting.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation of organs, fatigue, infusion reactions; Pemetrexed and Carboplatin can lead to blood count changes, nausea, kidney issues, and potential allergic reactions.
STAGGER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My lung cancer is non-squamous and has spread to other areas.
Select...
I have not received chemoimmunotherapy.
STAGGER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of clinical benefit
Secondary outcome measures
Incidence of adverse events
Objective response rate (ORR)
Overall survival (OS)
+1 moreSTAGGER Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: Immuno-ChemoExperimental Treatment3 Interventions
ArmB receives immunotherapy on D1 and chemotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle.
Group II: Arm A: Chemo-ImmunoExperimental Treatment3 Interventions
ArmA receives chemotherapy on D1 and immunotherapy on D8 of a 28-day cycle for the first 2cycles. After the first 2cycles, patients on Arm A and Arm B will be administered chemotherapy and immunotherapy on D1 of a 21day cycle for cycles 3 and 4. After 4cycles of chemo-immunotherapy, patients receive maintenance therapy with durvalumab and pemetrexed until treatment discontinuation. Maintenance therapy is administered on D1 of a 21day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,612,114 Total Patients Enrolled
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,605 Total Patients Enrolled
Wallace Akerley, MDPrincipal InvestigatorHuntsman Cancer Institute
4 Previous Clinical Trials
144 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have had an organ transplant from someone else.I haven't taken immunosuppressive drugs, except allowed steroids, in the last 14 days.I have not had radiation therapy in the last 2 weeks.I have or had an autoimmune or inflammatory disorder.I have recovered from side effects of previous treatments, with only mild symptoms remaining.You have a history of a current immune system problem.I have not had major surgery in the last 28 days.You have a disease that can be measured using CT or MRI scans according to specific guidelines.I can take care of myself and am up and about more than half of my waking hours.I have not received a live vaccine in the last 30 days and won't while on the trial.My lung cancer is non-squamous and has ALK or EGFR mutations.I am using or willing to use effective birth control during and for 3 months after the study.I am willing and able to follow the study's treatment plan and attend all visits.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.My lung cancer is non-squamous and has spread to other areas.I have not received chemoimmunotherapy.My blood, liver, and kidney functions are within normal ranges.You are expected to live for at least 12 more weeks.I have not been diagnosed with any cancer other than my current one in the last 2 years.My cancer has spread to my brain and is not under control.I have HIV with a detectable viral load in the last 6 months.I do not have any uncontrolled illnesses.I have had cancer spread to the lining of my brain and spinal cord.I do not have an active infection like TB, hepatitis B, or C.I am post-menopausal or not pregnant if pre-menopausal.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Chemo-Immuno
- Group 2: Arm B: Immuno-Chemo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration approved Carboplatin for clinical use?
"Given the Phase 2 status of Carboplatin, with some evidence for safety but none yet to support its efficacy, our team at Power assigned it a risk rating of 2."
Answered by AI
How many participants are currently engaged in this research?
"Affirmative. The information present on clinicaltrials.gov reveals that this research is presently searching for participants. This trial was initially listed on June 16th 2020 and recently revised on March 1st 2022, with the intention of recruiting 84 individuals from a single site."
Answered by AI
What therapeutic effects can be achieved with the use of Carboplatin?
"Carboplatin, a medication commonly prescribed to treat thymoma in its later stages, has also been known to aid patients with advanced testicular cancer, carcinomas of all types, and select forms of neuroendocrine diseases."
Answered by AI
Is this research endeavor recruiting new participants at this time?
"Affirmative. The information visible on clinicaltrials.gov corroborates that this trial, which was first unveiled on June 16th 2020, is actively recruiting for 84 participants at a single medical site."
Answered by AI
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