Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.
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|ClinicalTrials.gov Identifier: NCT02964689|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2016
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Non-small Cell Lung Cancer KRAS Gene Mutation Lung Cancer||Drug: Binimetinib Drug: Pemetrexed Drug: Cisplatin||Phase 1|
There is a need for more effective therapies for patients with advanced NSCLC driven by the RAS/MEK/ERK pathway. These tumors are generally aggressive, are almost exclusively of non-squamous histology, and represent the largest group of patients with advanced NSCLC harboring specific driver mutations in Western populations.
Based on recent preclinical and clinical evidence, mitogen-activated protein kinase kinase (MEK)-inhibition plus first-line chemotherapy is a promising new treatment for patients with NSCLC and KRAS [v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog] mutations.
Binimetinib is a medication without marketing authorization. Pemetrexed and cisplatin have marketing authorization in Switzerland and in EU for the treatment of non-small cell lung cancer (NSCLC) and will be administered as standard backbone treatment according to their Swissmedic-approved indication, dose and route of administration. Binimetinib, pemetrexed and cisplatin are IMP in the context of this phase I trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Binimetinib, Pemetrexed and Cisplatin, Followed by Maintenance With Binimetinib and Pemetrexed, in Patients With Advanced Non-small Cell Lung Cancer NSCLC With KRAS Mutations. A Multicenter Phase IB Trial.|
|Actual Study Start Date :||April 12, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Combination of binimetinib, pemetrexed and cisplatin
The trial consists of two parts:
Binimetinib will be administered in combination with pemetrexed and cisplatin (induction therapy), and with pemetrexed only (maintenance therapy), during the first 2 weeks of each cycle. Cycles will be repeated every 21 days.
Other Name: MEK162
Pemetrexed 500 mg/m2 i.v. is applied on day 1 of each cycle, before cisplatin administration
Cisplatin 75 mg/m2 i.v. is applied on day 1 of each induction therapy cycle. The drug must be administered after pemetrexed infusion
- Dose-limiting toxicities (DLTs) [ Time Frame: within 21 days from the first dose ]A DLT is defined as an AE or abnormal laboratory value assessed as at least possibly related to trial treatment (binimetinib in combination with pemetrexed and cisplatin), which occurs ≤ 21 days following the first dose of trial treatment during cycle 1.
- Objective response (OR) [ Time Frame: at 30 months after start of trial ]OR will include complete and partial responses based on RECIST 1.1 criteria. Best response will be the best result by investigator and RECIST 1.1 in the planned follow-up CT scans.
- Progression-free survival (PFS) [ Time Frame: at 30 months after start of trial ]PFS will be calculated from registration until documented tumor progression according to RECIST 1.1 or death due to any reason, whichever occurs first.
- Overall survival (OS) [ Time Frame: at 30 months after start of trial ]OS will be calculated from registration until death due to any reason.
- Adverse events (AEs) [ Time Frame: at 30 months after start of trial ]AEs will be assessed according to NCI CTCAE V.4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964689
|Basel, Switzerland, 4031|
|IOSI Ospedale Regionale di Bellinzona e Valli|
|Bellinzona, Switzerland, 6500|
|Chur, Switzerland, CH-7000|
|Kantonsspital St. Gallen|
|St. Gallen, Switzerland, 9007|
|Study Chair:||Martin Früh, MD||Cantonal Hospital of St. Gallen|