Phase I/II study to evaluate safety and activity of oral administration of S 49076 in combination with gefitinib in adult patients with EGFR mutated advanced non-small cell lung cancer who have progressed while on treatment with EGFR tyrosine kinase inhibitor (TKI) therapy.

Phase 1

• Conditions: ocally advanced or metastatic non-small-cell lung cancer; MedDRA version: 20.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIBSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002646-31-HU
• Lead Sponsor: Institut de Recherche International Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 171

Inclusion Criteria

-Male or female patient aged = 18 years old or legal age of the majority in the country.
-Histologically or cytologically confirmed stage IIIB/IV NSCLC ( locally advanced or metastatic, non-eligible for radical chemoradiotherapy or surgery with curative intention).
-Progression will have occurred on single agent EGFR TKI treatment (erlotinib, gefitinib, icotinib, afatinib,dacomitinib) in the 1st line setting or in the 2nd line (after a first line of chemotherapy).
-Patients must meet definition of acquired resistance based on the modified Jackman criteria.
-Patients must have measurable tumour disease according to RECIST v1.1. (with at least one measurable lesion).
-Estimated life expectancy > 12 weeks.
-Eastern Cooperative Oncology Group (ECOG) performance status = 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion Criteria

-Foreseeable poor compliance to the study procedures.
-Legally incapacitated person under guardianship or trusteeship.
-Pregnant or breast-feeding women.
-Unable to undergo CT scans or MRI.
-Patients who have received more than 1 line of chemotherapy and more than 1 line of erlotinib, gefitinib, icotinib ,afatinib or dacotinimib.
-Blood transfusion within 2 weeks prior to the inclusion.
-Major surgery within 4 weeks prior to the inclusion
-Prior radiotherapy within 4 weeks prior to the inclusion (within 1 week for palliative radiotherapy at localised lesions)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified