Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

December 23, 2013

Primary Completion Date

December 12, 2017

Study Completion Date

October 14, 2021

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

Tepotinib

Tepotinib was administered at a dose range of 300 or 500 milligram (mg) (Phase 1b) and the recommended phase II dose (RP2D) determined in the Phase 1b in Phase II orally once daily over a 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment. RP2D was determined as per safety monitoring committee (SMC) discretion.

DRUG

Gefitinib

Gefitinib was administered at a dose of 250 mg orally as once daily over a 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment.

DRUG

Pemetrexed

Pemetrexed was administered at a dose of 500 milligram per square meter (mg/m\^2) as intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.

DRUG

Cisplatin

Cisplatin was administered at a dose of 75 mg/m\^2 as intravenous infusion over 2 hours on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.

DRUG

Carboplatin

Carboplatin was administered intravenously on Day 1 of each 21-day cycle at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.

Trial Locations (44)

Unknown

Beijing Cancer Hospital, Beijing

Beijing Chest Hospital, Beijing

Peking Union Medical College Hospital, Beijing

Jilin Cancer Hospital, Changchun

Jilin University, Changchun

Fuzhou General Hospital, Fuzhou

Guangdong Provincial People's Hospital, Guangzhou

Sir Run Run Shaw Hospital Cardiology, Hangzhou

The First Affiliated Hospital of College of Medicine, Hangzhou

Shanghai Chest Hospital, Shanghai

Tongji Hospital, Wuhan

Fourth Military Medical University, Xi'an

Zhejiang Cancer Hospital, Zhejiang

Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario, Catanzaro

IEO Istituto Europeo di Oncologia, Milan

University Malaya Medical Centre, Kuala Lumpur

Beacon International Specialist Centre Sdn Bhd, Petaling Jaya

National Cancer Center, Singapore

National University Hospital, Singapore

Raffles Hospital, Singapore

Chungbuk National University Hospital, Cheongju-si

Kyungpook National University Hospital, Daegu

Chonnam National University Hwasun Hospital, Hwasun

CHA Bundang Medical Center, CHA University, Seongnam-si

Seoul National University Bundang Hospital, Seongnam-si

Severance Hospital Yonsei University Health System, Seongnam-si

Asan medical Centre, Seoul

Gangnam Severance Hospital Yonsei University, Seoul

Korea University Anam Hospital, Seoul

Samsung Medical Center, Seoul

Seoul National Universtiy Hospital, Seoul

The Catholic University of Korea St Mary s Hospital, Seoul

The Catholic University of Korea St. Vincent's Hospital, Suwon

Hospital Universitari Vall d'Hebron, Barcelona

Hospital General Universitario Gregorio Marañon, Madrid

Hospital Clinico Universitario, Valencia

Hospital Alvaro Cunqueiro, Vigo

Chang Gung Memorial Hospital-Kaohsiung, Kaohsiung City

China Medical University Hospital, Taichung

Taichung Veterans General Hospital, Taichung

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Tri-Service General Hospital, Taipei

Chang Gung Memorial Hospital Linkou, Taoyuan District

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01982955 - Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT) | Biotech Hunter | Biotech Hunter