A Phase II, single-arm trial to investigate tepotinib in advanced (locally advanced or metastatic) non-small cell lung cancer with MET exon 14 (METex14) skipping alterations or MET amplification (VISION)

Conditions

Lung Cancer

Brief summary

Objective response (confirmed CR or PR) determined according to RECIST Version 1.1, based on independent review.

Detailed description

1. Objective response rate assessed as per Investigator, 2. Duration of response as assessed by independent review committee, 3. Duration of response as assessed by investigator, 4. Objective disease control Rate as assessed by independent review committee, 5. Objective disease control Rate as assessed by investigator, 6. Progression free survival as assessed by independent review committee, 7. Progression free survival as assessed by investigator, 8. Overall survival, 9. Number of subjects with TEAEs and deaths, 10. Number of subjects with markedly abnormal vital signs, ECG, physical examination and ECOG PS., 11. Health Related Quality of Life Parameters, 12. Maximum plasma concentration (Cmax) of Drug, 13. Volume of distribution (Vz/F) of drug, 14. Total Clearance (Cl) of drug, 15. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis).

Related papers

No related papers found yet.

Interventions

DRUGTepotinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response (confirmed CR or PR) determined according to RECIST Version 1.1, based on independent review.	—

Secondary

Measure	Time frame
1. Objective response rate assessed as per Investigator, 2. Duration of response as assessed by independent review committee, 3. Duration of response as assessed by investigator, 4. Objective disease control Rate as assessed by independent review committee, 5. Objective disease control Rate as assessed by investigator, 6. Progression free survival as assessed by independent review committee, 7. Progression free survival as assessed by investigator, 8. Overall survival, 9. Number of subjects with TEAEs and deaths, 10. Number of subjects with markedly abnormal vital signs, ECG, physical examination and ECOG PS., 11. Health Related Quality of Life Parameters, 12. Maximum plasma concentration (Cmax) of Drug, 13. Volume of distribution (Vz/F) of drug, 14. Total Clearance (Cl) of drug, 15. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis).	—

Measure

Time frame

1. Objective response rate assessed as per Investigator, 2. Duration of response as assessed by independent review committee, 3. Duration of response as assessed by investigator, 4. Objective disease control Rate as assessed by independent review committee, 5. Objective disease control Rate as assessed by investigator, 6. Progression free survival as assessed by independent review committee, 7. Progression free survival as assessed by investigator, 8. Overall survival, 9. Number of subjects with TEAEs and deaths, 10. Number of subjects with markedly abnormal vital signs, ECG, physical examination and ECOG PS., 11. Health Related Quality of Life Parameters, 12. Maximum plasma concentration (Cmax) of Drug, 13. Volume of distribution (Vz/F) of drug, 14. Total Clearance (Cl) of drug, 15. Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis).

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Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed