Study evaluating the combination of cetuximab with afatinib for patient with EGFR mutated lung cancer

Phase II study evaluating the combination of cetuximab with afatinib as first-line treatment for patients with EGFR mutated Non Small Cell Lung Cancer - ACE : Afatinib plus Cetuximab for EGFR Mutant Lung Cancers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003390-15-FR

Enrollment

170

Registered

2015-12-14

Start date

2015-11-20

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non Small Cell Lung Cancer with EGFR mutation MedDRA version: 18.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classif

Interventions

Trade Name: Erbitux Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 Overall survival Response rate Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation) Toxicities (CTCAE 4.0 criteria) Quality of life (EQ-5D);Primary end point(s): Time to treatment failure Treatment failure is defined as treatment withdrawal regardless of the reason.;Timepoint(s) of evaluation of this end point: 9 months	—

Measure

Time frame

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 Overall survival Response rate Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation) Toxicities (CTCAE 4.0 criteria) Quality of life (EQ-5D);Primary end point(s): Time to treatment failure Treatment failure is defined as treatment withdrawal regardless of the reason.;Timepoint(s) of evaluation of this end point: 9 months

—

Secondary

Measure	Time frame
Secondary end point(s): Progression free survival Overall survival Response rate Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation) Toxicities (CTCAE 4.0 criteria) Quality of life (EQ-5D);Timepoint(s) of evaluation of this end point: 9 months	—

Countries

France

Contacts

Public ContactIFCT

IFCT

contact@ifct.fr+33156811045

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026