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Platinum-containing Compounds
Chemo/Immunotherapy for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Thomas Lycan, Jr., D.O., M.H.S.
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old
Patients must have normal organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of 4th cycle of treatment (12 weeks)
Awards & highlights
Study Summary
This trial is comparing how well two groups of cancer patients respond to immunotherapy. One group has cancer that is not as advanced, and the other group has cancer that is more advanced. The goal is to show that the group with more advanced cancer does just as well as the other group when treated with immunotherapy.
Who is the study for?
This trial is for adults with non-small cell lung cancer that's metastatic or can't be surgically removed, and who haven't had chemo or immunotherapy before. They should have a life expectancy over 3 months, normal organ/marrow function, and no history of certain conditions like pneumonitis treated with steroids.Check my eligibility
What is being tested?
The study tests if patients with lower performance status (weaker condition) do as well on first-line immunotherapy-based treatments as those in better condition. It involves drugs like Pembrolizumab and chemotherapy agents, along with quality of life assessments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to Pembrolizumab, such as inflammation in organs; chemotherapy may cause fatigue, nausea, low blood counts increasing infection risk. Quality of life questionnaires assess the impact.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My blood tests show normal white blood cell and platelet counts.
Select...
My lung cancer cannot be removed by surgery and has no cure with standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to end of 4th cycle of treatment (12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of 4th cycle of treatment (12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants with Progression-Free Survival
Secondary outcome measures
Change in Overall Quality of Life/Global Health Status - EORTC QLQ-C30
Incidences of Grade 3 to Grade 5 Treatment-Related Adverse Events
Proportion of Participants with Deterioration in Symptoms - QLQ-LC13
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Performance Status 2 ParticipantsExperimental Treatment8 Interventions
ALL study participants will receive pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle.
Participants with predictive biomarker PD-L1 greater than or equal to 50%: Participants will not receive any other drugs besides pembrolizumab.
Participants with Non-squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will ALSO receive:
- Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.
PLUS
- Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
Participants with Squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will also receive:
Carboplatin AUC 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS
Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. OR
Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles
Group II: Performance Status 0-1 ParticipantsExperimental Treatment8 Interventions
ALL study participants will receive pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle.
Participants with predictive biomarker PD-L1 greater than or equal to 50%: Participants will not receive any other drugs besides pembrolizumab.
Participants with Non-squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will ALSO receive:
- Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.
PLUS
- Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
Participants with Squamous subtype, predictive biomarker (PD-L1 less than 50%): Participants will also receive:
Carboplatin AUC 5 IV on day 1 of each 3-week cycle for 4 cycles. PLUS
Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles. OR
Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Nab paclitaxel
2014
Completed Phase 2
~140
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,098 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,284 Total Patients Enrolled
Thomas Lycan, Jr., D.O., M.H.S.Principal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My blood tests show normal white blood cell and platelet counts.I have an autoimmune disease treated within the last 2 years.I haven't had chemotherapy or immunotherapy for my cancer, except possibly for early-stage treatment.I have had lung inflammation treated with steroids.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My lung cancer cannot be removed by surgery and has no cure with standard treatments.I agree to use birth control during the study.I can take care of myself and am up and about more than half of my waking hours.You are expected to live for more than 3 months.My lung cancer has a specific mutation that requires targeted therapy.Your cancer must be visible on imaging tests according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Performance Status 0-1 Participants
- Group 2: Performance Status 2 Participants
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.
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