Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Sangmyung Woo, MD

This study is for verification of predictive biomarkers for pancreatic cancer treatment using multi-center liquid biopsy.

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

* Quantification and monitoring of KRAS mutations Using droplet digital PCR in ctDNA extracted from collected patient samples.
* Correlation analysis of KRAS mutation results with clinical data.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

* Gene panel composition for pancreatic cancer therapeutic target determination and monitoring.
* A panel was performed using gDNA and ctDNA of tumor tissue collected from pancreatic cancer patients.
* Comparative analysis of panel results and quantitative KRAS mutations and evaluation of clinical applicability.

Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy

Clinical applicability of KRAS mutations using circulating-tumor DNA in pancreatic cancer patients.

Discovery of biomarkers for predicting pancreatic cancer prognosis through ctDNA panel.

National Cancer Center, Korea

Chief, Senior Scientist

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Amino Acids

Docetaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib 150 mg/day per os until disease progression or unacceptable toxicity develops

Erlotinib

Docetaxel 75 mg/mq on day 1, every 21 days (3-weekly schedule) or Docetaxel 35 mg/mq 0n day 1,8 and 15 every 28 days (weekly schedule). _Until disease progression or unacceptable toxicity develops

Marina C Garassino, MD

Serena Girelli, Biologist

Giuseppe Nastasi, MD

Vittorio Ferrari, MD

Emanuela Vattemi, MD

Bruno Massidda, MD

Antonio Nuzzo, MD

Gianmaria Fiorentini, MD

Francesco Ferrau, MD

Luciano Isa, MD

Giambattista Roda, MD

Gianbattista Roda, MD

Ornella Gottardi, MD

Daniele Fagnani, MD

Sergio Palmeri, MD

Giorgio Cruciani, MD

Alessandra Zoboli, MD

Franco Spremberg, MD

Giuseppe Grimaldi, MD

Sergio Crispino, MD

Fausto Roila, MD

Claudio Verusio, MD

Andrea Bonetti, MD

Bruno Daniele, MD

Roberto Labianca, MD

Efisio Defraia, MD

Ida Colantonio, MD

Andrea Decensi, MD

Liberato Di Lullo, MD

Antonio Ardizzoia, MD

Gabriella Farina, MD

Maurizio Tomirotti, MD

Paolo Foa, MD

Maria Cristina Locatelli, MD

Maria Cristina Locatelli Locatelli, MD

Elena Piazza, MD

Oscar Alabiso, MD

Luigi Cavanna, MD

Salvatore Tumolo, MD

Ida Pavese, MD

Cora N Sternberg, MD

Enrico Cortesi, MD

Flavia Longo, MD

Maria Mauri, MD

Antonio Contu, MD

Antonio Farris, MD

Giuseppe Valmadre, MD

Alessandro Bertolini, MD

Alberto Scanni, MD

The aim of this study is to assess the superiority of docetaxel in comparison to erlotinib in second line in wild-type EGFR tumour patients.

Erlotinib is registered in all patients affected with NSCLC in second and subsequent lines with a small benefit on Overall Survival. Recent evidence suggest that patients with EGFR mutations have a clear benefit when they are treated with EGFR tyrosine kinase inhibitors, while the role of these drugs in wild-type EGFR patients, that are representing the large majority (about 85-90%), is still unclear and no properly planned trials assessed before this issue. Recently, indirect evidence on subgroup analyses on randomized trial suggest that chemotherapy might be superior to erlotinib in wild-type EGFR patients.

Moreover, several authors do not recommend the use of EGFR determined with immunohistochemistry (IHC) or FISH because they do not reproducibly predict outcome.

For these reasons the protocol was amended in May 2011 in a superiority trial of docetaxel versus erlotinib, while the first version was aimed to assess the interaction with biomarkers.

Tarceva Italian Lung Optimization tRial

Optimization of Erlotinib for the Treatment of Patients With Advanced Non Small Cell Lung Cancer: an Italian Randomized Trial

Mario Negri Institute for Pharmacological Research

Niguarda Hospital

Fatebenefratelli and Ophthalmic Hospital

Alberto Scanni MD

Micronutrients

Hematinics

Vitamins

Pemetrexed

Cisplatin

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

The trial consists of two parts:

* Part 1: dose escalation based on the 3+3 design with 2 doses of binimetinib
* Part 2: expansion cohort at the recommended maximum tolerated dose (MTD) level of binimetinib

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.

Binimetinib

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

Martin Früh, MD

The aim is to determine the recommended phase 2 dose (RP2D) of binimetinib in combination with pemetrexed and cisplatin, and to demonstrate that the combination is feasible and has preliminary activity in previously untreated patients with advanced NSCLC and documented KRAS mutations.

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.

Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.

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.

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.

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.

PFS will be calculated from registration until documented tumor progression according to RECIST 1.1 or death due to any reason, whichever occurs first.

OS will be calculated from registration until death due to any reason.

AEs will be assessed according to NCI CTCAE V.4.03.

Swiss Group for Clinical Cancer Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Verification of Predictive Biomarkers for Pancreatic Cancer Treatment Using Multicenter Liquid Biopsy	NCT04241367	Pancreas Adenoc...		-	National Cancer Center, Korea
Tarceva Italian Lung Optimization tRial	NCT00637910	Non Small Cell ...	Erlotinib Docetaxel	18 Years -	Fatebenefratelli and Ophthalmic Hospital
Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.	NCT02964689	Advanced Non-sm... KRAS Gene Mutat... Lung Cancer	Binimetinib Pemetrexed Cisplatin	18 Years - 75 Years	Swiss Group for Clinical Cancer Research
Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.	NCT02964689	Advanced Non-sm... KRAS Gene Mutat... Lung Cancer	Binimetinib Pemetrexed Cisplatin	18 Years - 75 Years	Swiss Group for Clinical Cancer Research

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