CLINICAL TRIAL

Tepotinib for Carcinoma, Non-Small-Cell Lung

Locally Advanced
Metastatic
Waitlist Available · 18+ · All Sexes · Salzburg, Austria

This study is evaluating whether a drug may help treat lung cancer.

See full description

About the trial for Carcinoma, Non-Small-Cell Lung

Eligible Conditions
Lung Neoplasms · Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification · Carcinoma, Non-Small-Cell Lung

Treatment Groups

This trial involves 2 different treatments. Tepotinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tepotinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tepotinib
FDA approved

Side Effect Profile for Phase 2: Tepotinib 500 mg

Phase 2: Tepotinib 500 mg
Show all side effects
65%
Oedema peripheral
33%
Diarrhoea
31%
Ascites
31%
Asthenia
27%
Hypoalbuminaemia
22%
Nausea
20%
Fatigue
18%
Constipation
16%
Abdominal pain
16%
Decreased appetite
14%
Vomiting
14%
Anaemia
14%
Blood creatinine increased
14%
Disease progression
12%
Pleural effusion
12%
Aspartate aminotransferase increased
10%
Blood bilirubin increased
10%
Lipase increased
10%
Back pain
10%
Hyperkalaemia
10%
Blood alkaline phosphatase increased
10%
Pruritus
8%
Pyrexia
8%
Bone pain
8%
Abdominal pain upper
8%
Rash
8%
Hyperbilirubinaemia
6%
Oedema
6%
Alanine aminotransferase increased
6%
Urinary tract infection
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Acute kidney injury
6%
Blood urea increased
6%
Hyponatraemia
4%
Hepatocellular injury
4%
Conjunctivitis
4%
Renal failure
4%
International normalised ratio increased
4%
Abdominal distension
4%
Anxiety
4%
Dysgeusia
4%
Hypotension
4%
Cough
4%
Hypertransaminasaemia
4%
Vertigo
4%
Localised oedema
4%
Weight decreased
4%
Headache
4%
Hypercreatininaemia
4%
Hypocalcaemia
4%
Arthralgia
4%
Insomnia
4%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Sciatica
2%
Gastroenteritis
2%
Discomfort
2%
Peritonitis bacterial
2%
Type 1 diabetes mellitus
2%
Pneumonia aspiration
2%
Chronic kidney disease
2%
Depressed mood
2%
Angular cheilitis
2%
Dyspepsia
2%
Gastric varices
2%
Paronychia
2%
Rhabdomyolysis
2%
Gastrointestinal haemorrhage
2%
Hepatic failure
2%
Cancer pain
2%
Sepsis
2%
Tumour pain
2%
Cerebral thrombosis
2%
Lymph node pain
2%
Thrombocytopenia
2%
Blood thyroid stimulating hormone increased
2%
Inguinal hernia
2%
Varices oesophageal
2%
Hepatic pain
2%
Depression
2%
Chills
2%
Generalised oedema
2%
Hepatomegaly
2%
Jaundice
2%
Lung infection
2%
Influenza
2%
Clostridium difficile colitis
2%
Prothrombin time prolonged
2%
Infection
2%
Herpes zoster
2%
Fall
2%
Urobilinogen urine increased
2%
Pneumonia
2%
Cell death
2%
Rash pustular
2%
Septic shock
2%
Upper respiratory tract infection
2%
Overdose
2%
Hyperglycaemia
2%
Pain in extremity
2%
Hyperlipasaemia
2%
Metastases to bone
2%
Malnutrition
2%
Musculoskeletal pain
2%
Muscle spasms
2%
Hepatic encephalopathy
2%
Musculoskeletal chest pain
2%
Pollakiuria
2%
Pain in jaw
2%
Glomerulonephritis membranoproliferative
2%
Hyperkeratosis
2%
Night sweats
2%
Dry skin
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Alopecia
2%
Deep vein thrombosis
2%
Hypovolaemic shock
2%
Vascular stent stenosis
2%
Cholangitis
2%
Odynophagia
2%
Coagulopathy
2%
Atrial fibrillation
2%
Bronchitis
2%
Haematemesis
2%
Weight increased
2%
Acute respiratory failure
2%
Rash maculo-papular
2%
Hot flush
2%
Nail disorder
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Device related infection
2%
Dizziness
2%
Dry mouth
2%
Dysphagia
2%
Genital herpes
2%
Hypercalcaemia
2%
Skin lesion
2%
Hypertension
2%
Hypoglycaemic coma
2%
Nasopharyngitis
2%
Transaminases increased
2%
Ketonuria
2%
Scrotal oedema
2%
Wound
2%
Lacrimation increased
2%
Chest pain
0%
Rib fracture
0%
Prostatitis
0%
Glomerular filtration rate decreased
0%
Migraine with aura
0%
Lymphoedema
0%
Peritonitis
0%
Hepatorenal syndrome
0%
Gamma-glutamyltransferase increased
0%
Coma
0%
Post procedural infection
0%
Eyelid oedema
0%
Pain
0%
Lumbar vertebral fracture
0%
Renal impairment
0%
Dysuria
0%
Osteoporosis
0%
Venous thrombosis
0%
Peripheral venous disease
0%
Hepatic vein thrombosis
0%
Hepatitis B
0%
Toothache
0%
Amylase increased
0%
Flank pain
0%
Epistaxis
0%
Papule
0%
Haemoglobin decreased
0%
Eructation
Oedema peripheral
65%
Diarrhoea
33%
Ascites
31%
Asthenia
31%
Hypoalbuminaemia
27%
Nausea
22%
Fatigue
20%
Constipation
18%
Abdominal pain
16%
Decreased appetite
16%
Vomiting
14%
Anaemia
14%
Blood creatinine increased
14%
Disease progression
14%
Pleural effusion
12%
Aspartate aminotransferase increased
12%
Blood bilirubin increased
10%
Lipase increased
10%
Back pain
10%
Hyperkalaemia
10%
Blood alkaline phosphatase increased
10%
Pruritus
10%
Pyrexia
8%
Bone pain
8%
Abdominal pain upper
8%
Rash
8%
Hyperbilirubinaemia
8%
Oedema
6%
Alanine aminotransferase increased
6%
Urinary tract infection
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Acute kidney injury
6%
Blood urea increased
6%
Hyponatraemia
6%
Hepatocellular injury
4%
Conjunctivitis
4%
Renal failure
4%
International normalised ratio increased
4%
Abdominal distension
4%
Anxiety
4%
Dysgeusia
4%
Hypotension
4%
Cough
4%
Hypertransaminasaemia
4%
Vertigo
4%
Localised oedema
4%
Weight decreased
4%
Headache
4%
Hypercreatininaemia
4%
Hypocalcaemia
4%
Arthralgia
4%
Insomnia
4%
Gastrooesophageal reflux disease
4%
General physical health deterioration
2%
Sciatica
2%
Gastroenteritis
2%
Discomfort
2%
Peritonitis bacterial
2%
Type 1 diabetes mellitus
2%
Pneumonia aspiration
2%
Chronic kidney disease
2%
Depressed mood
2%
Angular cheilitis
2%
Dyspepsia
2%
Gastric varices
2%
Paronychia
2%
Rhabdomyolysis
2%
Gastrointestinal haemorrhage
2%
Hepatic failure
2%
Cancer pain
2%
Sepsis
2%
Tumour pain
2%
Cerebral thrombosis
2%
Lymph node pain
2%
Thrombocytopenia
2%
Blood thyroid stimulating hormone increased
2%
Inguinal hernia
2%
Varices oesophageal
2%
Hepatic pain
2%
Depression
2%
Chills
2%
Generalised oedema
2%
Hepatomegaly
2%
Jaundice
2%
Lung infection
2%
Influenza
2%
Clostridium difficile colitis
2%
Prothrombin time prolonged
2%
Infection
2%
Herpes zoster
2%
Fall
2%
Urobilinogen urine increased
2%
Pneumonia
2%
Cell death
2%
Rash pustular
2%
Septic shock
2%
Upper respiratory tract infection
2%
Overdose
2%
Hyperglycaemia
2%
Pain in extremity
2%
Hyperlipasaemia
2%
Metastases to bone
2%
Malnutrition
2%
Musculoskeletal pain
2%
Muscle spasms
2%
Hepatic encephalopathy
2%
Musculoskeletal chest pain
2%
Pollakiuria
2%
Pain in jaw
2%
Glomerulonephritis membranoproliferative
2%
Hyperkeratosis
2%
Night sweats
2%
Dry skin
2%
Dyspnoea
2%
Dyspnoea exertional
2%
Alopecia
2%
Deep vein thrombosis
2%
Hypovolaemic shock
2%
Vascular stent stenosis
2%
Cholangitis
2%
Odynophagia
2%
Coagulopathy
2%
Atrial fibrillation
2%
Bronchitis
2%
Haematemesis
2%
Weight increased
2%
Acute respiratory failure
2%
Rash maculo-papular
2%
Hot flush
2%
Nail disorder
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Device related infection
2%
Dizziness
2%
Dry mouth
2%
Dysphagia
2%
Genital herpes
2%
Hypercalcaemia
2%
Skin lesion
2%
Hypertension
2%
Hypoglycaemic coma
2%
Nasopharyngitis
2%
Transaminases increased
2%
Ketonuria
2%
Scrotal oedema
2%
Wound
2%
Lacrimation increased
2%
Chest pain
2%
Rib fracture
0%
Prostatitis
0%
Glomerular filtration rate decreased
0%
Migraine with aura
0%
Lymphoedema
0%
Peritonitis
0%
Hepatorenal syndrome
0%
Gamma-glutamyltransferase increased
0%
Coma
0%
Post procedural infection
0%
Eyelid oedema
0%
Pain
0%
Lumbar vertebral fracture
0%
Renal impairment
0%
Dysuria
0%
Osteoporosis
0%
Venous thrombosis
0%
Peripheral venous disease
0%
Hepatic vein thrombosis
0%
Hepatitis B
0%
Toothache
0%
Amylase increased
0%
Flank pain
0%
Epistaxis
0%
Papule
0%
Haemoglobin decreased
0%
Eructation
0%
This histogram enumerates side effects from a completed 2018 Phase 1 & 2 trial (NCT02115373) in the Phase 2: Tepotinib 500 mg ARM group. Side effects include: Oedema peripheral with 65%, Diarrhoea with 33%, Ascites with 31%, Asthenia with 31%, Hypoalbuminaemia with 27%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
is required by the Food and Drug Administration (FDA) According to the Food and Drug Administration, any trial-specific screening procedure requires a signed, written informed consent from the subject or their legal representative prior to participation. show original
), and of legal competence to enter into a contract You must be male or female, at least 18 years old (or have reached the age of majority according to local laws and regulations), and competent to enter into a contract to participate in this promotion. show original
The disease is measurable and confirmed by an independent review committee (IRC) using the RECIST version 1.1 guidelines. show original
method (e.g., intrauterine device, contraceptive implant, or tubal ligation) during the entire study and for 6 months following the last dose of study medication A male subject must agree to use a highly effective contraception method (e.g., intrauterine device, contraceptive implant, or tubal ligation) during the entire study and for 6 months following the last dose of study medication show original
who have had one prior platinum-based chemotherapy regimen People who have been diagnosed with advanced non-small cell lung cancer (NSCLC) and have had one prior chemotherapy treatment using platinum-based drugs are candidates for this study. show original
Patients who have not been treated before and those who have only received two prior lines of treatment are both considered to be first-line patients. show original
, have a poor prognosis Subjects that have MET alterations, specifically METex14 skipping alterations in plasma and/or tissue as determined by the central laboratory or by an assay with appropriate regulatory status, have a poor prognosis. show original
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
method A woman who does not want to have a baby and is willing to use a highly effective contraceptive method. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline up to 20 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline up to 20 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline up to 20 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tepotinib will improve 1 primary outcome and 15 secondary outcomes in patients with Carcinoma, Non-Small-Cell Lung. Measurement will happen over the course of Baseline until PD/ death within 84 days of last tumor assessment; assessed up to 20 months.

Duration of response as assessed by investigator
BASELINE UNTIL PD/ DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Duration of response according to RECIST 1.1 and as per investigator's discretion is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
BASELINE UNTIL PD/ DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Progression free survival as assessed by investigator
BASELINE UNTIL PD OR DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Progression free survival as assessed by investigator is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (as assessed by investigator) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
BASELINE UNTIL PD OR DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Progression free survival as assessed by independent review committee
BASELINE UNTIL PD OR DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Progression free survival as assessed by independent review committee is defined as the time (in months) from the first administration of trial treatment to the date of the first documentation of PD (based on independent review) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. PD is defined as at least a 20 % increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
BASELINE UNTIL PD OR DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Duration of response as assessed by independent review committee
BASELINE UNTIL PD/ DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Duration of response according to RECIST 1.1 and as adjudicated by an Independent review committee is the time from when the CR/PR (whichever is first) criteria are first met until progression of disease (PD) or death due to any cause within 84 days of the last tumor assessment, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
BASELINE UNTIL PD/ DEATH WITHIN 84 DAYS OF LAST TUMOR ASSESSMENT; ASSESSED UP TO 20 MONTHS
Occurrence of Treatment emergent adverse event (TEAEs) and deaths
FROM THE FIRST DOSE OF STUDY DRUG ADMINISTRATION UNTIL 33 DAYS AFTER THE LAST DOSE OF STUDY DRUG ADMINISTRATION, ASSESSED UP TO 20 MONTHS
This outcome measure will be presented as the percentage of subjects with any (serious) adverse event (AE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.
FROM THE FIRST DOSE OF STUDY DRUG ADMINISTRATION UNTIL 33 DAYS AFTER THE LAST DOSE OF STUDY DRUG ADMINISTRATION, ASSESSED UP TO 20 MONTHS
Plasma concentrations of the drug
PRE-DOSE, AT 1.5 HOURS POST-DOSE AND AT 4 HOURS POST-DOSE ON CYCLE 1, DAY 1 AND ON CYCLE 2, DAY 1
PRE-DOSE, AT 1.5 HOURS POST-DOSE AND AT 4 HOURS POST-DOSE ON CYCLE 1, DAY 1 AND ON CYCLE 2, DAY 1
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of carcinoma, non-small-cell lung?

Although signs of carcinoma, NSCLC, may be present, these signs are nonspecific and can be easily overlooked. The most significant factors associated with NSCLC are smoking history, age, race, and history of prior cancer. The most significant factors associated with poor survival after lung cancer were smoking and the presence of a solid tumor on chest radiography or computed tomographic scan. The stage of NSCLC is a more significant factor with worse prognosis.

Anonymous Patient Answer

What is carcinoma, non-small-cell lung?

This article was based on the work of many authors. The authors and journal to which it refers have approved its reuse under appropriate agreement.

Anonymous Patient Answer

Can carcinoma, non-small-cell lung be cured?

In our patient series, there was no significant difference in the rate of progression or survival between patients whose disease had been cured and those whose disease did not. In short, the disease can be controlled, but has not yet been cured.

Anonymous Patient Answer

What causes carcinoma, non-small-cell lung?

The carcinoma, nonsmall-cell, lung may have the following cause: genetic predisposition, environmental factors (i.e., smoking), or a combination of the above. If no significant family history of disease or known environmental disease-causing factors can be proved, the possibility of genetic predisposition should be further investigated, particularly the gene loci involved in the familial transmission of this disease in twins. The exact gene(s) that contributes to the disease remains undefined.

Anonymous Patient Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

around 25,000 new cases of carcinoma, non-small-cell lung will be diagnosed in 2022. More than 50% of these cases will be seen in people who are younger than 40 years of age, most commonly in women and males.

Anonymous Patient Answer

What are common treatments for carcinoma, non-small-cell lung?

The majority of patients, however, obtain good and sustained quality of life, despite poor performance status and poor lung function. In addition, there was also a trend toward improved survival in those who were treated with chemotherapy. As a whole, our experience suggests that the clinical management of carcinoma, non-small-cell lung may be more complex than is currently appreciated.

Anonymous Patient Answer

Have there been other clinical trials involving tepotinib?

To our knowledge, this is the first review of published trials of tepotinib. There are presently trials that assess the best option in different population subgroups.

Anonymous Patient Answer

How quickly does carcinoma, non-small-cell lung spread?

This analysis supports the "one-step" hypothesis of LS spread at a time when the infiltrating carcinoma is small and the metastatic distance close to the primary site is short.

Anonymous Patient Answer

What is the latest research for carcinoma, non-small-cell lung?

Cancer Research is the largest and most comprehensive peer-reviewed journal devoted to human cancer research. It covers advances of all types, and readers rely on it not just for reviews of a new class of drugs.

Anonymous Patient Answer

What are the latest developments in tepotinib for therapeutic use?

Findings from a recent study, we examined the most recent development of tepotinib and the mechanisms behind resistance. The most important mechanism is amplification of epidermal growth factor receptor (EGFR) and its downstream PI3K/Akt/mTOR cascades conferring cross-resistance to EGFR inhibitors. Further research must determine whether these mechanisms can be overcome.

Anonymous Patient Answer

What are the chances of developing carcinoma, non-small-cell lung?

Findings from a recent study support the proposition that smoking is a risk factor for developing CCRCC, and that this may be related to lung cancer.

Anonymous Patient Answer

What is the survival rate for carcinoma, non-small-cell lung?

Survival rate following curative resection of non-small-cell lung carcinoma may not be influenced by cigarette smoking, whereas smoking cessation could have a significant impact on survival.

Anonymous Patient Answer
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