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Taxane
Trametinib + Docetaxel for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Shirish M Gadgeel
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
Because the composition, pharmacokinetics (PK), and metabolism of many herbal supplements are unknown, the concurrent use of all herbal supplements is prohibited during the study (including but not limited to St. John's wort, kava, ephedra [ma huang], ginko biloba, dehydroepiandrosterone [DHEA], yohimbe, saw palmetto, or ginseng)
Patients must have Zubrod performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing how well trametinib and docetaxel work to treat patients with stage IV KRAS mutation positive non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) that has a specific KRAS mutation. Participants must not have brain metastases unless treated and stable, no recent chemotherapy or investigational drugs, normal organ function tests, no history of significant heart disease or interstitial lung disease, and cannot be pregnant. They should not have had certain prior treatments like MEK inhibitors.Check my eligibility
What is being tested?
The study is testing the combination of trametinib, which blocks enzymes needed for tumor growth, and docetaxel, a chemotherapy drug that kills or stops cancer cells from dividing. The goal is to see if this combo works better than current treatments for NSCLC with KRAS mutations.See study design
What are the potential side effects?
Trametinib may cause rash, diarrhea, fatigue and heart issues while docetaxel can lead to hair loss, low blood cell counts increasing infection risk and fatigue. Side effects vary by individual; some may experience more severe reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not taking any herbal supplements.
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I can take care of myself and am up and about more than 50% of my waking hours.
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I haven't taken any cancer drugs or been in a trial for 2 weeks and have recovered from side effects.
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My lung cancer is stage IV or recurrent with a confirmed KRAS mutation.
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I have not been treated with docetaxel or drugs targeting specific cancer pathways.
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I can take pills and don't have major GI issues affecting absorption.
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I have never had interstitial lung disease or pneumonitis.
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I do not have ongoing or untreated eye retina problems.
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I am not allergic to trametinib, its related drugs, or any agents used in the study.
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I do not have active hepatitis B or C, and I am not HIV positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in All KRAS Mutant Participants
Secondary outcome measures
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Overall Survival in All KRAS Mutants
Overall Survival in Participants With G12C KRAS Mutation
+6 moreOther outcome measures
Response Rates in the Presence of LKB1 Mutations
Response Rates in the Presence of p53 Mutations
Side effects data
From 2021 Phase 2 trial • 206 Patients • NCT0203411058%
Pyrexia
42%
Nausea
35%
Vomiting
33%
Diarrhoea
33%
Fatigue
28%
Gamma-glutamyltransferase increased
28%
Chills
28%
Rash
26%
Aspartate aminotransferase increased
23%
White blood cell count decreased
23%
Cough
23%
Anaemia
23%
Decreased appetite
23%
Headache
21%
Constipation
21%
Blood alkaline phosphatase increased
19%
Dry mouth
19%
Hyperglycaemia
19%
Myalgia
16%
Alanine aminotransferase increased
16%
Asthenia
16%
Abdominal pain upper
16%
Thrombocytopenia
16%
Dyspnoea
14%
Hypertension
14%
Arthralgia
14%
Insomnia
12%
Platelet count decreased
12%
Eczema
12%
Blood creatinine increased
12%
Pruritus
12%
Abdominal pain
12%
Hypomagnesaemia
12%
Hyponatraemia
12%
Erythema
9%
Oedema peripheral
9%
Hypokalaemia
9%
Dermatitis acneiform
9%
Rash maculo-papular
9%
Neutrophil count decreased
9%
Weight increased
9%
Back pain
9%
Dry skin
7%
Blood bilirubin increased
7%
Sepsis
7%
Neutropenia
7%
Mucosal inflammation
7%
Oedema
7%
Cholangitis
7%
Hypoalbuminaemia
7%
Stomatitis
7%
Dyspepsia
7%
Influenza like illness
7%
Herpes zoster
7%
Glycosylated haemoglobin increased
7%
Weight decreased
7%
Musculoskeletal pain
7%
Pain in extremity
7%
Anxiety
7%
Acute kidney injury
7%
Night sweats
5%
Hypophosphataemia
5%
Skin lesion
5%
Erythema nodosum
5%
Dry eye
5%
Toothache
5%
Muscle spasms
5%
Blood creatine phosphokinase increased
5%
Hyperuricaemia
5%
Gastrooesophageal reflux disease
5%
Leukopenia
5%
Folliculitis
5%
Urinary tract infection
5%
Fall
5%
Lymphocyte count decreased
5%
Hypoglycaemia
5%
Joint swelling
5%
Neuropathy peripheral
5%
Epistaxis
5%
Oropharyngeal pain
5%
Acne
5%
Hyperkeratosis
2%
Hot flush
2%
Femoral neck fracture
2%
Hypersensitivity
2%
Upper respiratory tract infection
2%
Productive cough
2%
Pain in jaw
2%
Epilepsy
2%
Peripheral sensory neuropathy
2%
Depression
2%
Hypercalcaemia
2%
Dizziness
2%
Skin mass
2%
Pneumonia
2%
Thrombophlebitis
2%
Tachycardia
2%
Musculoskeletal chest pain
2%
Dysgeusia
2%
Sciatica
2%
Gastroenteritis
2%
Febrile neutropenia
2%
Atrial fibrillation
2%
Oral pain
2%
Rectal haemorrhage
2%
Paronychia
2%
Device related infection
2%
Rhinitis
2%
Sinusitis
2%
Respiratory tract infection
2%
Hyperkalaemia
2%
Transaminases increased
2%
Dehydration
2%
Spinal pain
2%
Haemorrhoids
2%
Cataract
2%
Eye pain
2%
Vision blurred
2%
Visual impairment
2%
Abdominal discomfort
2%
Abdominal distension
2%
Gait disturbance
2%
Non-cardiac chest pain
2%
Xerosis
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Rash pustular
2%
Tooth abscess
2%
Tooth infection
2%
Procedural pain
2%
Blood lactate dehydrogenase increased
2%
Blood uric acid increased
2%
C-reactive protein increased
2%
Muscular weakness
2%
Neck pain
2%
Basal cell carcinoma
2%
Seborrhoeic keratosis
2%
Paraesthesia
2%
Proteinuria
2%
Renal failure
2%
Nasal congestion
2%
Pleural effusion
2%
Nail discolouration
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Photosensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biliary Tract Cancer (BTC) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib, docetaxel)Experimental Treatment3 Interventions
Patients receive trametinib PO on days 1-21. Patients also receive docetaxel IV on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Trametinib
2014
Completed Phase 2
~1550
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
Shirish M GadgeelPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had radiation that didn't affect more than 25% of my bone marrow and have recovered from its side effects.I am not taking any herbal supplements.Your hemoglobin level is at least 9 grams/dl, and this was checked within the last 28 days before joining the study.I haven't taken any cancer treatment or experimental drugs in the last 14 days and have recovered from side effects.Your blood platelet count is at least 100,000 per microliter, and this result was confirmed within the last 28 days before enrolling in the study.I can take care of myself and am up and about more than 50% of my waking hours.I don't have active brain cancer or symptoms after treatment for it.I have never had interstitial lung disease or pneumonitis.I do not have ongoing or untreated eye retina problems.I haven't taken any cancer drugs or been in a trial for 2 weeks and have recovered from side effects.My lung cancer is stage IV or recurrent with a confirmed KRAS mutation.My cancer can be seen on scans taken within the last 28 days.I don't have active brain cancer or symptoms after treatment for brain metastases.My lung cancer has worsened after 1-2 treatments, including one with platinum.I have not been treated with docetaxel or drugs targeting specific cancer pathways.I have recovered from side effects of my previous treatment, except for hair loss.My kidney function, measured by creatinine levels or clearance, is within the required range.I can take pills and don't have major GI issues affecting absorption.I don't have serious heart or stroke issues in the past 6 months.My heart's electrical activity is normal, and if I have atrial fibrillation, it's controlled or mild.My heart's pumping ability is within the normal range.I am not allergic to trametinib, its related drugs, or any agents used in the study.I do not have active hepatitis B or C, and I am not HIV positive.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or cancers I've been free from for 3 years.I am not pregnant or nursing and will use effective birth control during the study.My white blood cell count is healthy.I have not been treated with anti-PD-1 or anti-PDL1 therapies.I have not been treated with anti-PD-1 or anti-PDL1 therapies.I haven't had major surgery in the last 28 days and have recovered from any past surgeries.My liver function tests are within the required range.My bilirubin levels are within normal range as tested in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trametinib, docetaxel)
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.
How large is this study in terms of active participants?
"Unfortunately, this particular trial is not actively recruiting patients at the moment. However, there are nearly 1400 other cancer studies and 431 Trametinib trials that are presently looking for participants."
Answered by AI
Are there still opportunities available to join this research project?
"The clinical trial referenced is not recruiting patients at this time. Based on the information found on clinicaltrials.gov, which was last updated on October 18th 2022, the study is no longer looking for candidates. There are, however, 1830 other trials that are recruiting patients as we speak."
Answered by AI
What are some of the most popular off-label uses for Trametinib?
"Trametinib can be used to target the brca1 gene, neoplasm metastasis, and metastatic bladder cancer."
Answered by AI
Has Trametinib been federally sanctioned for use?
"Trametinib's safety is estimated to be a 2. In other words, while there is some evidence that the drug is safe, there is no data supporting whether or not it is effective."
Answered by AI
Are there other ongoing investigations involving Trametinib?
"As of now, 431 clinical trials investigating Trametinib are ongoing with 138 of them being Phase 3 studies. The majority of these research projects are based in Fuzhou, Fujian; however, there are 28190 total locations running trials for Trametinib."
Answered by AI
In how many different places is this trial being run today?
"There are over 100 enrolling sites for this trial, including Providence Saint Mary Regional Cancer Center in Walla Walla, Washington, OptumCare Cancer Care at MountainView in Las Vegas, Nevada, and Saint Joseph Medical Center in Bloomington, Illinois."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
Michigan
What site did they apply to?
Monroe Cancer Center
Toledo Clinic Cancer Centers-Monroe
Heartland Regional Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
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