Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer (ACE-Lung)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02716311|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : April 24, 2020
Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: Afatinib Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||December 2020|
Afatinib 40 mg/d until progression
Experimental: Afatinib + cetuximab
Afatinib 40 mg/d until progression + cetuximab 500 mg/m² every 2 weeks during 6 months (beginning at D15 at 250 mg/m²)
- Time to Treatment Failure [ Time Frame: 9 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 month ]
- Response Rate [ Time Frame: 9 months ]
- Overall survival [ Time Frame: 6 months ]
- Overall survival [ Time Frame: 9 months ]
- Overall survival [ Time Frame: 12 months ]
- Progression-Free Survival [ Time Frame: 6 months ]
- Progression-Free Survival [ Time Frame: 9 months ]
- Progression-Free Survival [ Time Frame: 12 months ]
- Progression-Free Survival [ Time Frame: 18 months ]
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): NCT02716311
|Principal Investigator:||Alexis CORTOT, MD, PhD||CHRU, Lille|
|Principal Investigator:||Jacques CADRANEL, MD, PhD||AP-HP Hôpital Tenon, Paris|