Study evaluating the combination of cetuximab with afatinib for patient with EGFR mutated lung cancer
- Conditions
- Advanced Non Small Cell Lung Cancer with EGFR mutationMedDRA version: 18.1Level: PTClassification code 10029520Term: Non-small cell lung cancer stage IIIASystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-003390-15-FR
- Lead Sponsor
- IFCT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
Stage III or IV NSCLC, non irradiable non operable
Non squamous NSCLC histologically or cytologically confirmed
No previous treatment of NSCLC
EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q orS768I mutations or exon 19 insertion)
Presence of at least one lesion that can be measured
PS 0 or 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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
Symptomatic brain metastasis or requiring immediate radiotherapy
T790M mutation or exon 20 insertion
Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
Interstitial pneumopathy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluating efficacy and toxicity of the combination of afatinib with cetuximab versus afatinib alone, in first-line treatment of patient with a EGFR mutated NSCLC;Secondary Objective: Progression free survival<br>Overall survival<br>Response rate<br>Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation)<br>Toxicities (CTCAE 4.0 criteria)<br>Quality of life (EQ-5D);Primary end point(s): Time to treatment failure <br>Treatment failure is defined as treatment withdrawal regardless of the reason.;Timepoint(s) of evaluation of this end point: 9 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Progression free survival<br>Overall survival<br>Response rate<br>Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation)<br>Toxicities (CTCAE 4.0 criteria)<br>Quality of life (EQ-5D);Timepoint(s) of evaluation of this end point: 9 months