Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

• ClinicalTrials.gov Identifier: NCT02864992
• Recruitment Status: Active, not recruiting
• First Posted: August 12, 2016
• Results First Posted: June 9, 2023
• Last Update Posted: June 9, 2023
• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborator: Merck KGaA, Darmstadt, Germany
• Information provided by (Responsible Party): EMD Serono ( EMD Serono Research & Development Institute, Inc. )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification; Lung Adenocarcinoma Stage IIIB/IV
• Intervention: Drug: Tepotinib
• Enrollment: 337

Participant Flow

Recruitment Details
Pre-assignment Details	For Cohort A: A total of 168 participants were screened of which 152 participants were enrolled to receive the study drug. For Cohort B: A total of 32 participants were screened of which 24 participants were enrolled to receive the study drug. For Cohort C: A total of 175 participants were screened of which 161 participants were enrolled to receive the study drug.

Arm/Group Title	Part 1: Cohort A: METex14 Skipping Alterations	Part 1: Cohort B: MET Amplification	Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Arm/Group Description	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Period Title: Overall Study
Started	152	24	161
Completed	137	23	128
Not Completed	15	1	33
Reason Not Completed
still on treatment	15	1	33

Baseline Characteristics

Arm/Group Title		Part 1: Cohort A: METex14 Skipping Alterations	Part 1: Cohort B: MET Amplification	Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations	Total
Arm/Group Description		Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.	Total of all reporting groups
Overall Number of Baseline Participants		152	24	161	337
Baseline Analysis Population Description		All participants in Cohort A, Cohort B and Cohort C who were administered at least 1 dose of tepotinib.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	152 participants	24 participants	161 participants	337 participants
		73.0 (8.97)	62.3 (9.17)	71.5 (9.24)	71.5 (9.47)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	152 participants	24 participants	161 participants	337 participants
	Female	73 48.0%	3 12.5%	86 53.4%	162 48.1%
	Male	79 52.0%	21 87.5%	75 46.6%	175 51.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	152 participants	24 participants	161 participants	337 participants
	Hispanic or Latino	1 0.7%	1 4.2%	1 0.6%	3 0.9%
	Not Hispanic or Latino	148 97.4%	23 95.8%	157 97.5%	328 97.3%
	Unknown or Not Reported	3 2.0%	0 0.0%	3 1.9%	6 1.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	152 participants	24 participants	161 participants	337 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	38 25.0%	07 29.2%	68 42.2%	113 33.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	01 0.7%	0 0.0%	02 1.2%	3 0.9%
	White	108 71.1%	17 70.8%	87 54.0%	212 62.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	05 3.3%	0 0.0%	04 2.5%	9 2.7%

Outcome Measures

1. Primary Outcome

Title	Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
Description	Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was 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.
Time Frame	Time from first treatment up to data cutoff (approximately Month 66)

Outcome Measure Data

Analysis Population Description

Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.

Arm/Group Title	Part 1: Cohort A: METex14 Skipping Alterations
Arm/Group Description:	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Overall Number of Participants Analyzed	152
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	46.7; (38.6 to 55.0)

2. Primary Outcome

Title	Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Description	Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was 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.
Time Frame	Time from first treatment up to data cutoff (approximately Month 66)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants in Cohort B who were administered at least 1 dose of tepotinib, including participants with a MET Amplification.

Arm/Group Title	Part 1: Cohort B: MET Amplification
Arm/Group Description:	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Overall Number of Participants Analyzed	24
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	41.7; (22.1 to 63.4)

3. Primary Outcome

Title	Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
Description	Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was 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.
Time Frame	Time from first treatment up to data cutoff (approximately Month 66)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants in Cohort C who were administered at least 1 dose of tepotinib.

Arm/Group Title	Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Arm/Group Description:	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Overall Number of Participants Analyzed	161
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	54.7; (46.6 to 62.5)

4. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Duration of Response (DOR) Assessed by Investigator
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by IRC
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Objective Disease Control Rate Assessed by Investigator
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Progression-free Survival by IRC Assessment
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

10. Secondary Outcome

Title	Part 1 & 2: Cohort A + B +C: Progression-free Survival by Investigator Assessment
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

11. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Overall Survival (OS)
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

12. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

13. Secondary Outcome

Title	Part 1 & 2: Cohort A + B +C: Number of Participants With Markedly Abnormal Clinical Laboratory Tests
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

14. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Number of Participants With Markedly Abnormal Vital Signs and Physical Examination
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

15. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

16. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

17. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

18. Secondary Outcome

Title	Part 1 & 2: Cohort A + B + C: Quality of Life (QoL) Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Description	[Not Specified]
Time Frame	Time from first treatment up to end of study (approximately Month 101)

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Time from first treatment up to data cutoff (approximately Month 74)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Part 1 & 2: Cohort A + B + C
Arm/Group Description	Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
All-Cause Mortality
	Part 1 & 2: Cohort A + B + C
	Affected / at Risk (%)
Total	200/337 (59.35%)
Serious Adverse Events
	Part 1 & 2: Cohort A + B + C
	Affected / at Risk (%)
Total	169/337 (50.15%)
Blood and lymphatic system disorders
Anaemia * 1	2/337 (0.59%)
Cardiac disorders
Acute coronary syndrome * 1	1/337 (0.30%)
Acute myocardial infarction * 1	1/337 (0.30%)
Atrial fibrillation * 1	3/337 (0.89%)
Bradycardia * 1	1/337 (0.30%)
Cardiac arrest * 1	1/337 (0.30%)
Cardiac failure * 1	3/337 (0.89%)
Cardiac tamponade * 1	1/337 (0.30%)
Cardio-respiratory arrest * 1	2/337 (0.59%)
Ischaemic cardiomyopathy * 1	1/337 (0.30%)
Myocardial infarction * 1	1/337 (0.30%)
Myopericarditis * 1	1/337 (0.30%)
Endocrine disorders
Adrenal insufficiency * 1	1/337 (0.30%)
Gastrointestinal disorders
Abdominal discomfort * 1	1/337 (0.30%)
Abdominal pain * 1	2/337 (0.59%)
Ascites * 1	1/337 (0.30%)
Constipation * 1	1/337 (0.30%)
Gastrointestinal haemorrhage * 1	1/337 (0.30%)
Haemorrhoids * 1	1/337 (0.30%)
Ileus * 1	2/337 (0.59%)
Inguinal hernia * 1	1/337 (0.30%)
Intestinal obstruction * 1	1/337 (0.30%)
Large intestinal obstruction * 1	1/337 (0.30%)
Nausea * 1	2/337 (0.59%)
Umbilical hernia * 1	1/337 (0.30%)
Vomiting * 1	2/337 (0.59%)
General disorders
Asthenia * 1	3/337 (0.89%)
Chest pain * 1	1/337 (0.30%)
Death * 1	2/337 (0.59%)
Disease progression * 1	16/337 (4.75%)
Fatigue * 1	1/337 (0.30%)
General physical health deterioration * 1	12/337 (3.56%)
Generalised oedema * 1	8/337 (2.37%)
Malaise * 1	1/337 (0.30%)
Mucosal inflammation * 1	1/337 (0.30%)
Non-cardiac chest pain * 1	1/337 (0.30%)
Oedema * 1	1/337 (0.30%)
Oedema peripheral * 1	11/337 (3.26%)
Pyrexia * 1	3/337 (0.89%)
Hepatobiliary disorders
Bile duct stone * 1	1/337 (0.30%)
Cholangitis * 1	1/337 (0.30%)
Cholecystitis acute * 1	1/337 (0.30%)
Cholelithiasis * 1	1/337 (0.30%)
Immune system disorders
Hypersensitivity * 1	2/337 (0.59%)
Infections and infestations
Bacterial infection * 1	1/337 (0.30%)
COVID-19 pneumonia * 1	2/337 (0.59%)
Cellulitis * 1	1/337 (0.30%)
Cholecystitis infective * 1	1/337 (0.30%)
Conjunctivitis * 1	1/337 (0.30%)
Empyema * 1	1/337 (0.30%)
Escherichia urinary tract infection * 1	1/337 (0.30%)
Infection * 1	1/337 (0.30%)
Infectious pleural effusion * 1	1/337 (0.30%)
Pleural infection * 1	1/337 (0.30%)
Pneumonia * 1	18/337 (5.34%)
Pneumonia aspiration * 1	1/337 (0.30%)
Pneumonia bacterial * 1	1/337 (0.30%)
Pyelonephritis acute * 1	1/337 (0.30%)
Respiratory tract infection * 1	1/337 (0.30%)
Sepsis * 1	4/337 (1.19%)
Septic embolus * 1	1/337 (0.30%)
Septic shock * 1	1/337 (0.30%)
Upper respiratory tract infection * 1	2/337 (0.59%)
Urinary tract infection * 1	3/337 (0.89%)
Urinary tract infection bacterial * 1	1/337 (0.30%)
Viral upper respiratory tract infection * 1	1/337 (0.30%)
Injury, poisoning and procedural complications
Accidental overdose * 1	2/337 (0.59%)
Fall * 1	1/337 (0.30%)
Femoral neck fracture * 1	2/337 (0.59%)
Femur fracture * 1	1/337 (0.30%)
Hip fracture * 1	1/337 (0.30%)
Humerus fracture * 1	1/337 (0.30%)
Radius fracture * 1	1/337 (0.30%)
Spinal fracture * 1	2/337 (0.59%)
Subdural haematoma * 1	1/337 (0.30%)
Subdural haemorrhage * 1	1/337 (0.30%)
Investigations
Alanine aminotransferase increased * 1	2/337 (0.59%)
Aspartate aminotransferase increased * 1	2/337 (0.59%)
Blood creatinine increased * 1	1/337 (0.30%)
Lipase increased * 1	2/337 (0.59%)
Lymphocyte count decreased * 1	1/337 (0.30%)
Neutrophil count decreased * 1	1/337 (0.30%)
Troponin increased * 1	1/337 (0.30%)
Metabolism and nutrition disorders
Decreased appetite * 1	2/337 (0.59%)
Dehydration * 1	1/337 (0.30%)
Electrolyte imbalance * 1	1/337 (0.30%)
Hypoalbuminaemia * 1	2/337 (0.59%)
Hypokalaemia * 1	1/337 (0.30%)
Hyponatraemia * 1	2/337 (0.59%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	2/337 (0.59%)
Back pain * 1	4/337 (1.19%)
Bone pain * 1	1/337 (0.30%)
Haematoma muscle * 1	1/337 (0.30%)
Musculoskeletal chest pain * 1	1/337 (0.30%)
Pathological fracture * 1	1/337 (0.30%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain * 1	4/337 (1.19%)
Malignant pleural effusion * 1	4/337 (1.19%)
Metastases to spine * 1	1/337 (0.30%)
Neoplasm progression * 1	1/337 (0.30%)
Pericardial effusion malignant * 1	1/337 (0.30%)
Prostatic adenoma * 1	1/337 (0.30%)
Tumour associated fever * 1	1/337 (0.30%)
Tumour haemorrhage * 1	1/337 (0.30%)
Tumour pain * 1	2/337 (0.59%)
Nervous system disorders
Aphasia * 1	1/337 (0.30%)
Cerebral infarction * 1	2/337 (0.59%)
Cerebrovascular accident * 1	4/337 (1.19%)
Dizziness * 1	1/337 (0.30%)
Epilepsy * 1	1/337 (0.30%)
Haemorrhage intracranial * 1	1/337 (0.30%)
Headache * 1	1/337 (0.30%)
Neuralgia * 1	1/337 (0.30%)
Parkinson's disease * 1	1/337 (0.30%)
Presyncope * 1	1/337 (0.30%)
Seizure * 1	1/337 (0.30%)
Spinal cord compression * 1	3/337 (0.89%)
Vocal cord paresis * 1	1/337 (0.30%)
Product Issues
Stent malfunction * 1	1/337 (0.30%)
Psychiatric disorders
Assisted suicide * 1	1/337 (0.30%)
Confusional state * 1	2/337 (0.59%)
Delusion * 1	1/337 (0.30%)
Mental status changes * 1	1/337 (0.30%)
Renal and urinary disorders
Acute kidney injury * 1	4/337 (1.19%)
Chronic kidney disease * 1	1/337 (0.30%)
Hydronephrosis * 1	1/337 (0.30%)
Renal colic * 1	1/337 (0.30%)
Renal failure * 1	1/337 (0.30%)
Renal impairment * 1	1/337 (0.30%)
Renal pain * 1	1/337 (0.30%)
Ureteric stenosis * 1	1/337 (0.30%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure * 1	1/337 (0.30%)
Chronic obstructive pulmonary disease * 1	1/337 (0.30%)
Dyspnoea * 1	12/337 (3.56%)
Haemothorax * 1	1/337 (0.30%)
Hypoxia * 1	1/337 (0.30%)
Interstitial lung disease * 1	3/337 (0.89%)
Pleural effusion * 1	18/337 (5.34%)
Pneumonitis * 1	1/337 (0.30%)
Pneumothorax * 1	5/337 (1.48%)
Pulmonary embolism * 1	7/337 (2.08%)
Pulmonary haemorrhage * 1	1/337 (0.30%)
Respiratory failure * 1	4/337 (1.19%)
Respiratory tract haemorrhage * 1	1/337 (0.30%)
Skin and subcutaneous tissue disorders
Rash maculo-papular * 1	1/337 (0.30%)
Vascular disorders
Embolism * 1	1/337 (0.30%)
Phlebitis * 1	1/337 (0.30%)
Thrombosis * 1	1/337 (0.30%)
1 Term from vocabulary, MedDRA 24.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part 1 & 2: Cohort A + B + C
	Affected / at Risk (%)
Total	331/337 (98.22%)
Blood and lymphatic system disorders
Anaemia * 1	50/337 (14.84%)
Eye disorders
Lacrimation increased * 1	19/337 (5.64%)
Gastrointestinal disorders
Abdominal pain * 1	29/337 (8.61%)
Abdominal pain upper * 1	29/337 (8.61%)
Constipation * 1	69/337 (20.47%)
Diarrhoea * 1	95/337 (28.19%)
Nausea * 1	97/337 (28.78%)
Vomiting * 1	46/337 (13.65%)
General disorders
Asthenia * 1	46/337 (13.65%)
Fatigue * 1	51/337 (15.13%)
Generalised oedema * 1	22/337 (6.53%)
Oedema * 1	31/337 (9.20%)
Oedema peripheral * 1	237/337 (70.33%)
Pyrexia * 1	33/337 (9.79%)
Infections and infestations
Pneumonia * 1	24/337 (7.12%)
Urinary tract infection * 1	23/337 (6.82%)
Injury, poisoning and procedural complications
Fall * 1	18/337 (5.34%)
Investigations
Alanine aminotransferase increased * 1	56/337 (16.62%)
Amylase increased * 1	34/337 (10.09%)
Aspartate aminotransferase increased * 1	40/337 (11.87%)
Blood alkaline phosphatase increased * 1	35/337 (10.39%)
Blood creatinine increased * 1	96/337 (28.49%)
Gamma-glutamyltransferase increased * 1	28/337 (8.31%)
Lipase increased * 1	28/337 (8.31%)
Weight decreased * 1	22/337 (6.53%)
Metabolism and nutrition disorders
Decreased appetite * 1	65/337 (19.29%)
Hypoalbuminaemia * 1	108/337 (32.05%)
Hypocalcaemia * 1	33/337 (9.79%)
Hypokalaemia * 1	25/337 (7.42%)
Hyponatraemia * 1	25/337 (7.42%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	31/337 (9.20%)
Back pain * 1	39/337 (11.57%)
Pain in extremity * 1	17/337 (5.04%)
Nervous system disorders
Dizziness * 1	21/337 (6.23%)
Headache * 1	17/337 (5.04%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	49/337 (14.54%)
Dyspnoea * 1	69/337 (20.47%)
Pleural effusion * 1	37/337 (10.98%)
Skin and subcutaneous tissue disorders
Alopecia * 1	36/337 (10.68%)
Dry skin * 1	30/337 (8.90%)
Pruritus * 1	26/337 (7.72%)
Rash * 1	30/337 (8.90%)
Vascular disorders
Hypotension * 1	17/337 (5.04%)
1 Term from vocabulary, MedDRA 24.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Phone: +49-6151-72-5200
• EMail: service@emdgroup.com

Publications of Results:

Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. doi: 10.1056/NEJMoa2004407. Epub 2020 May 29.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.

Xiong W, Papasouliotis O, Jonsson EN, Strotmann R, Girard P. Population pharmacokinetic analysis of tepotinib, an oral MET kinase inhibitor, including data from the VISION study. Cancer Chemother Pharmacol. 2022 May;89(5):655-669. doi: 10.1007/s00280-022-04423-5. Epub 2022 Apr 6.

• Responsible Party: EMD Serono ( EMD Serono Research & Development Institute, Inc. )
• ClinicalTrials.gov Identifier: NCT02864992
• Other Study ID Numbers: MS200095-0022; 2015-005696-24 ( EudraCT Number )
• First Submitted: July 29, 2016
• First Posted: August 12, 2016
• Results First Submitted: May 15, 2023
• Results First Posted: June 9, 2023
• Last Update Posted: June 9, 2023