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Alkylating agents
Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
South Weymouth, MA
Phase 2
Waitlist Available
Led By Michael L Cheng, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically or cytologically confirmed stage IV NSCLC (AJCC 8th edition).
ECOG performance status 0-2 (see Appendix A)
Must not have
Participants who have had chemotherapy or radiotherapy within 1 week prior to entering the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up he time from registration to the earlier of progression or death due to any cause or 30 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking to see if a blood test can detect early response in patients being treated for lung cancer with pembrolizumab, and if so, whether patients should continue treatment with pembrolizumab or switch to pembrolizumab in combination with chemotherapy.
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Who is the study for?
Adults with stage IV Non-Small Cell Lung Cancer (NSCLC) who haven't had systemic anti-cancer therapy for it. They must have normal organ/marrow function, a PD-L1 tumor score ≥1%, and be able to use contraception. Excluded are those with certain genetic mutations, recent chemo/radiotherapy, uncontrolled illnesses, other investigational drugs, active autoimmune diseases needing high-dose steroids, known allergies to similar drugs, pregnancy/breastfeeding women, HIV/AIDS patients or uncontrolled brain metastases.Check my eligibility
What is being tested?
The trial is testing if a blood test called InVision can predict early response in NSCLC treated with pembrolizumab alone or combined with chemotherapy (carboplatin plus pemetrexed or paclitaxel). The goal is to see if the blood test results can guide whether to continue pembrolizumab alone or add chemotherapy.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation of organs and infusion reactions. Chemotherapy agents carboplatin and pemetrexed/paclitaxel can cause hair loss, nausea/vomiting, fatigue and increased risk of infection due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be at stage IV.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood counts, liver, and kidney functions are within normal ranges, and my cancer shows some response to immunotherapy.
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I am 18 years old or older.
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My cancer showed a significant decrease in specific DNA markers or remained low after starting treatment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had chemotherapy or radiotherapy in the last week.
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I do not have any serious illnesses that would stop me from following the study's requirements.
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I am not pregnant or breastfeeding.
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My cancer has specific genetic changes in EGFR, ALK, ROS1, or BRAF.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ he time from registration to the earlier of progression or death due to any cause or 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~he time from registration to the earlier of progression or death due to any cause or 30 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
6-month Progression Free Survival rate
Secondary study objectives
Early Plasma Response
Feasibility-adherence to protocol therapy for 4 cycles
Overall Survival
+1 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Oral candidiasis
19%
Tinnitus
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Localised oedema
7%
Urinary tract infection
7%
Ear pain
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pembrolizumab Cycles 1-2Experimental Treatment2 Interventions
* For the first two cycles, Pembrolizumab will be administered at a predetermined dose every 3 weeks.
* InVision plasma draw will take place at Cycle 1 Day 1 and Cycle 2 Day 1, with return of results to the treating oncologist prior to Cycle 3 Day 1.
* At Cycle 3, patients will be re-registered per the inclusion criteria into 3 arms;
* PEMBROLIZUMAB Alone
* PEMBROLIZUMAB + Doublet Chemotherapy
Group II: Pembrolizumab Alone, Cycle 3+Experimental Treatment1 Intervention
- Following imaging assessment at Cycle 3, participants will continue pembrolizumab alone if the following responses are observed:
* Response of Partial Response/Complete Response
* Response of Stable Disease with plasma response
* Response of Progressive Disease without worsening cancer symptoms AND plasma response
Group III: Pembrolizumab + Doublet Chemotherapy, Cycles 3+Experimental Treatment4 Interventions
* Following imaging assessment at Cycle 3, participants will receive pembrolizumab in combination with platinum doublet chemotherapy if they have a response of stable disease without plasma response, OR no plasma response and response of progressive disease without worsening cancer systems. Platinum doublet should be histology-appropriate and will be given on-label, per treating oncologist.
* PEMBROLIZUMAB
* Chemotherapy multiple agents systemic
* PEMETREXED
* CARBOPLATIN
* PACLITAXEL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2630
CARBOPLATIN
2005
Completed Phase 2
~80
PACLITAXEL
2013
Completed Phase 2
~100
Find a Location
Closest Location:Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore Hospital· South Weymouth, MA
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,122 Previous Clinical Trials
360,406 Total Patients Enrolled
Julia K. Rotow, MDLead Sponsor
InivataIndustry Sponsor
4 Previous Clinical Trials
658 Total Patients Enrolled
Michael L Cheng, MDPrincipal InvestigatorDana-Farber Cancer Institute
Julia K Rotow, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy or radiotherapy in the last week.My lung cancer is confirmed to be at stage IV.I have stable brain metastases and am not on high-dose steroids.I do not have any serious illnesses that would stop me from following the study's requirements.I am not on high-dose steroids or immune system medications, except for certain allowed conditions.I haven't had systemic anti-cancer therapy for stage IV NSCLC, but treatments for earlier stages are okay if they were over 6 months ago.I can take care of myself and am up and about more than half of my waking hours.My doctor thinks I am a good fit for combined chemo and immune therapy.My blood counts, liver, and kidney functions are within normal ranges, and my cancer shows some response to immunotherapy.My cancer has not worsened according to my last imaging and blood tests.My latest scans show how my cancer is responding to treatment.I agree to use birth control during and up to 4 months after the study.You have had allergic reactions to drugs similar to pembrolizumab or other drugs used in the study.I am not pregnant or breastfeeding.My cancer has specific genetic changes in EGFR, ALK, ROS1, or BRAF.I am 18 years old or older.Your disease can be seen on medical imaging, but it doesn't have to be measurable.My cancer showed a significant decrease in specific DNA markers or remained low after starting treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab Cycles 1-2
- Group 2: Pembrolizumab Alone, Cycle 3+
- Group 3: Pembrolizumab + Doublet Chemotherapy, Cycles 3+
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.