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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
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response Rate (Confirmed and Unconfirmed Complete and Partial Responses) in All KRAS Mutant Participants
Secondary study objectives
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 study objectives
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 • NCT0203411047%
Pyrexia
36%
Fatigue
33%
Anaemia
33%
Nausea
33%
Decreased appetite
28%
Rash
22%
Headache
22%
Constipation
22%
Pneumonia
22%
Chills
22%
Dyspnoea
19%
Dizziness
19%
Hypoalbuminaemia
19%
Vomiting
19%
Diarrhoea
19%
Hyponatraemia
17%
Dysphagia
17%
Blood alkaline phosphatase increased
17%
Back pain
14%
Aspartate aminotransferase increased
14%
Hypocalcaemia
14%
Dry mouth
14%
Hyperglycaemia
14%
Arthralgia
14%
Oedema peripheral
14%
White blood cell count decreased
14%
Insomnia
14%
Hypotension
11%
Hypokalaemia
11%
Haemoptysis
11%
Alanine aminotransferase increased
11%
Dry skin
11%
Hypothyroidism
11%
Pruritus
11%
Visual impairment
11%
Weight decreased
11%
Cough
8%
Productive cough
8%
Rash maculo-papular
8%
Upper respiratory tract infection
8%
Mucosal inflammation
8%
Hypercalcaemia
8%
Gastrooesophageal reflux disease
8%
Pleural effusion
8%
Night sweats
8%
Asthenia
8%
Ejection fraction decreased
8%
Electrocardiogram QT prolonged
8%
Gamma-glutamyltransferase increased
8%
Neutrophil count decreased
8%
Neck pain
6%
Rhinorrhoea
6%
Haematochezia
6%
Skin lesion
6%
Acute kidney injury
6%
Seborrhoeic keratosis
6%
Pulmonary embolism
6%
Thrombocytopenia
6%
Atrial fibrillation
6%
Stomatitis
6%
Rhinitis allergic
6%
Tachycardia
6%
Abdominal pain upper
6%
Hyperuricaemia
6%
Leukopenia
6%
Sinusitis
6%
Urinary tract infection
6%
Polyneuropathy
6%
Haematuria
6%
Neutropenia
6%
Ear pain
6%
Abdominal pain
6%
Feeling cold
6%
Non-cardiac chest pain
6%
Pain
6%
Fungal infection
6%
Nasopharyngitis
6%
Blood creatinine increased
6%
Blood urea increased
6%
Neutrophil count increased
6%
Hypomagnesaemia
6%
Myalgia
6%
Neuropathy peripheral
6%
Proteinuria
6%
Nasal congestion
6%
Pneumonitis
6%
Palmar-plantar erythrodysaesthesia syndrome
3%
Tinnitus
3%
Pelvic infection
3%
Hypophosphataemia
3%
Sepsis
3%
Malaise
3%
Cataract
3%
Rhabdomyolysis
3%
Dermatitis acneiform
3%
Erythema nodosum
3%
Femoral neck fracture
3%
Aortic thrombosis
3%
Hyperglycaemic hyperosmolar nonketotic syndrome
3%
Pollakiuria
3%
Flushing
3%
Oesophageal stenosis
3%
Atrioventricular block first degree
3%
Photophobia
3%
Dehydration
3%
Toothache
3%
Oral candidiasis
3%
Urinary retention
3%
Alopecia
3%
Skin mass
3%
Aspiration
3%
Vision blurred
3%
Oedema
3%
Depression
3%
Folliculitis
3%
Staphylococcal infection
3%
Clavicle fracture
3%
Aphasia
3%
Cardiac ventricular thrombosis
3%
Stress cardiomyopathy
3%
Oral pain
3%
Clostridium difficile infection
3%
Diverticulitis
3%
Pneumonia aspiration
3%
Pneumonia necrotising
3%
Wound infection
3%
Hyperkalaemia
3%
Rib fracture
3%
Bladder transitional cell carcinoma
3%
Facial nerve disorder
3%
Hypertension
3%
Paralysis recurrent laryngeal nerve
3%
Syncope
3%
Hallucination
3%
Pulmonary haematoma
3%
Sinus bradycardia
3%
Dry eye
3%
Abdominal distension
3%
Dyspepsia
3%
Gait disturbance
3%
Nodule
3%
Xerosis
3%
Conjunctivitis
3%
Tooth infection
3%
Procedural pain
3%
Blood creatine phosphokinase increased
3%
Platelet count decreased
3%
Weight increased
3%
Flank pain
3%
Muscular weakness
3%
Musculoskeletal chest pain
3%
Pain in extremity
3%
Hypoaesthesia
3%
Paraesthesia
3%
Anxiety
3%
Sleep disorder
3%
Dysphonia
3%
Epistaxis
3%
Upper-airway cough syndrome
3%
Wheezing
3%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Biliary Tract Cancer (BTC) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
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)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~6550
Trametinib
2014
Completed Phase 2
~1630
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,924 Previous Clinical Trials
41,017,891 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.
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