Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer (AFACET)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03727724|
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Afatinib Drug: Cetuximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Single Arm Study of Afatinib in Combination With Cetuximab in EGFR Exon 20 Insertion Positive Non-small-cell Lung Cancer|
|Actual Study Start Date :||December 4, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Afatinib plus cetuximab
Afatinib, 40 mg once daily, orally.
Cetuximab, 500 mg/m² intravenously, every 2 weeks.
Treatment will be continued until tumor progression (according RECIST v1.1) confirmed by tumor imaging, unacceptable toxicity, or death occurs.
- Disease control rate after 18 weeks [ Time Frame: 18 weeks ]To determine the disease control rate at 18 weeks of afatinib and cetuximab treatment in patients with NSCLC harboring an EGFR exon 20 insertion mutation.
- Objective tumor response [ Time Frame: Scans every 6 weeks until tumor progression, start of another treatment or death. ]Objective tumor response (complete response and partial response)determined by RECIST v1.1.
- Safety (intensity and incidence of adverse events) [ Time Frame: Up to 30 days after last study drug intake. ]Safety as indicated by intensity and incidence of adverse events, graded according to NCI CTCAE Version 4.03.
- Duration of response (DOR) [ Time Frame: Scans every 6 weeks until tumor progression ]Time from documentation of tumor response to disease progression
- Progression free survival [ Time Frame: Until progression, every 6 weeks up to progression ]Time from the date of start treatment to the date of the first documented tumor progression as determined by RECIST1.1, or death due to any cause
- Overall survival [ Time Frame: Every 6 weeks up to death ]Time form date of start treatment to the date of death from any cause
- Genetic profiling to assess predictors of response and resistance - circulating free (cf)DNA [ Time Frame: At baseline, cycle 1 day 15 and at treatment discontinuation (expected 6 months after start) ]cfDNA samples will be collected to assess predictors of response and resistance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727724
|Contact: J de Langen, MD, PhDfirstname.lastname@example.org|
|Contact: B van Veggel, MDemail@example.com|
|Antoni van Leeuwenhoek||Recruiting|
|Amsterdam, North-Holland, Netherlands, 1066 CX|
|Contact: Joop de Langen, MD, PhD +3120512 ext 2958 firstname.lastname@example.org|
|Contact: Bianca van Veggel, MD +3120512 ext 2958 email@example.com|
|VU Medical Center||Recruiting|
|Amsterdam, Netherlands, 1007 MB|
|Contact: S Hashemi, MD +31-20-4443999 S.Hashemi@vumc.nl|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: A.J. van der Wekken, MD, PhD +31-50-3616161 firstname.lastname@example.org|
|Maastricht UMC+||Not yet recruiting|
|Maastricht, Netherlands, 6229 HX|
|Contact: A Dingemans, MD, PhD +31-43-3876543 email@example.com|
|Principal Investigator:||J de Langen, MD, PhD||NKI-AvL|