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Alkylating Agent
Pevonedistat + Chemotherapy for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Ticiana A Leal
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have progressed on prior treatment with checkpoint inhibitor (PD-1/PD-L1 inhibitors) either as a single-agent therapy or in combination, as below
Glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with stage IIIB or IV non-small cell lung cancer. The drugs work in different ways to stop the growth of cancer cells. Giving the drugs together may work better than giving other standard chemotherapy drugs.
Who is the study for?
This trial is for adults with stage IIIB or IV non-small cell lung cancer (NSCLC) who have previously been treated with immunotherapy. They must have a life expectancy of at least 12 weeks, acceptable liver and kidney function, controlled CNS metastases if present, and no severe heart or lung conditions. Participants need to agree to use contraception and cannot be pregnant.Check my eligibility
What is being tested?
The study tests the effectiveness of combining MLN4924 (Pevonedistat) with Carboplatin and Paclitaxel in NSCLC patients who didn't respond well to prior treatments. It aims to see if this combination is better than standard chemotherapy by blocking enzymes that help cancer cells grow.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, hair loss from chemotherapy drugs like Carboplatin and Paclitaxel; Pevonedistat may cause blood count issues or organ inflammation. Side effects can vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after treatment with PD-1/PD-L1 inhibitors.
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My kidney function, measured by GFR, is above 30.
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I have NSCLC with specific genetic changes and have been treated with FDA-approved targeted therapy.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My lung cancer is at an advanced stage and cannot be surgically removed.
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My brain metastases are treated, symptoms stable for 2 weeks, and I'm off or reducing steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With an Overall Response
Secondary outcome measures
Duration of Progression Free Survival (PFS)
Number of Participants Reporting Grade 3, 4, and 5 Adverse Events
Overall Survival (OS)
Other outcome measures
ATF3 Expression Levels
B2M Expression Levels
GCLM Expression Levels
+13 moreSide effects data
From 2021 Phase 2 trial • 120 Patients • NCT0261077747%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, carboplatin, pevonedistat)Experimental Treatment3 Interventions
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30-60 minutes on day 1, and pevonedistat IV over 1 hour on days 1, 3, and 5. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Pevonedistat
2021
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,640 Total Patients Enrolled
Ticiana A LealPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious lung condition like COPD, lung scarring, or fibrosis.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I have severe liver problems or cirrhosis.I will not donate sperm during the study or for 4 months after the last dose.I have allergies to certain cancer drugs similar to MLN4924, carboplatin, or paclitaxel.I agree to use effective birth control during the study.My liver function tests are within the required range.Your total bilirubin level needs to be within the normal range for the hospital. If you have Gilbert's syndrome, your direct bilirubin level needs to be within 1.5 times the normal range for the hospital.I have a known heart or lung condition.I have a serious irregular heartbeat.I haven't had chemotherapy or radiotherapy in the last 2 weeks.My condition worsened after treatment with PD-1/PD-L1 inhibitors.My kidney function, measured by GFR, is above 30.I haven't had major surgery in the last 14 days and don't plan any during the study.I will not donate eggs during the study or for 4 months after the last dose.I have NSCLC with specific genetic changes and have been treated with FDA-approved targeted therapy.I have a bleeding disorder that is not under control.I am 18 years old or older.Your heart's pumping ability is at least 50%, as shown by a heart ultrasound or a special heart scan.I am fully active or can carry out light work.I am on medication for my symptomatic pulmonary hypertension.I have severe nerve pain or numbness in my hands or feet.I do not have a life-threatening illness unrelated to my cancer.Your heart's QTc interval is longer than 500 milliseconds when measured by the hospital's guidelines.My lung cancer is at an advanced stage and cannot be surgically removed.You are expected to live for at least 12 weeks.You are currently taking any other experimental medications.My high blood pressure is not under control.If you have HIV, you may not be able to participate in the study.You have enough white blood cells called neutrophils.Your platelet count is at least 150,000 per microliter.My brain metastases are treated, symptoms stable for 2 weeks, and I'm off or reducing steroids.I have recovered from side effects of previous cancer treatments, except for hair loss or nerve issues.Your disease can be measured using specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (paclitaxel, carboplatin, pevonedistat)
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.
Are there any other examples of Pevonedistat's medical applications?
"As of now, 1244 Pevonedistat clinical trials are underway with 345 in Phase 3. Out of the 67481 total locations for these trials, several are situated in Shanghai."
Answered by AI
Where are patients able to take part in this trial?
"Currently, this experiment is being conducted in 11 different locations. They are situated in Los Angeles, Newport Beach, and Tampa as well as 8 other cities. If you enroll, try to choose the location nearest to you to cut back on travel time."
Answered by AI
Are there any unfilled positions in this trial for new patients?
"While no longer recruiting patients, this study was last updated on September 16th, 2022. The trial was first posted on September 3rd, 2019. There are 5644 other clinical trials that are still looking for participants."
Answered by AI
How many people are participating in the trial?
"Unfortunately, this study is no longer recruiting participants. The original posting date was September 3rd, 2019 and the most recent update was on September 16th, 20202. On the bright side, there are currently 4400 other clinical trials actively seeking patients with metastatic lung non-small cell squamous carcinoma and 1244 studies for Pevonedistat that have open recruitment."
Answered by AI
Has Pevonedistat been cleared by the FDA for medical use?
"Pevonedistat's safety is based on phase 2 trial data, so it falls in the middle of our 1-3 scale at a 2."
Answered by AI
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