Trial Title:
Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
NCT ID:
NCT05673187
Condition:
NSCLC Stage IV
KRAS P.G12C
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Adagrasib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adagrasib
Description:
Adagrasib is administered at a dose of 600 mg orally, twice daily until progression or
unacceptable toxicity.
Arm group label:
Treatment Arm
Summary:
ADEPPT is an international, multicentre, single-arm phase II trial. The protocol
treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice
daily until progression or unacceptable toxicity.The primary objective of this trial is
to assess the clinical efficacy of adagrasib treatment, in terms of objective response,
in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients
with poor performance status (ECOG PS=2).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed stage IV NSCLC.
2. KRASG12C-mutation by local testing (by tissue or ctDNA).
3. Prior treatment with at least one line of systemic therapy for NSCLC (e.g.,
platinum-based doublet chemotherapy and/or immune-checkpoint inhibition or both).
4. Life expectancy ≥12 weeks.
5. Measurable disease according to RECIST v1.1.
6. Age ≥18 years with ECOG PS 2 (cohort 1), or age ≥70 years with ECOG PS 0-1 (cohort
2).
7. Adequate haematological, renal and liver function
8. Men and women of childbearing potential must agree to use use highly effective
contraceptive methods.
9. Women of childbearing potential, including women who had their last menstruation in
the last 2 years, must have a negative urinary or serum beta HCG pregnancy test
within 5 weeks before enrolment. Pregnancy test must be repeated within 7 days
before the first dose of adagrasib treatment.Ability to comply with the trial
protocol, in the investigator's judgment.
10. Written IC for study participation must be signed and dated by the patient and the
investigator prior to any study-related intervention, including the submission of
mandatory biomaterial.
Exclusion Criteria:
1. Prior investigational therapy within 28 days or at least 5 half-lives before
enrolment.
2. Prior treatment with an agent targeting KRASG12C.
3. Leptomeningeal disease or untreated brain metastases.
- Patient should be neurologically stable for at least 2 weeks before enrolment,
without the need for corticosteroids, except for prednisone (or its equivalent)
at a dose of ≤10 mg daily.
- For patients with definitively treated brain metastases, a time period of
minimum of 2 weeks must have elapsed from the last day of radiotherapy.
4. History of intestinal disease or major gastric surgery likely to alter absorption of
study treatment or inability to swallow oral medications.
5. Any of the following cardiac abnormalities:
- Unstable angina pectoris or myocardial infarction within 6 months prior to
enrolment.
- Symptomatic or uncontrolled atrial fibrillation within 6 months prior to
enrolment.
- Congestive heart failure ≥NYHA Class 3 within 6 months prior to enrolment.
- Prolonged QTc interval >480 ms or family or medical history of congenital Long
QT Syndrome.
6. History of stroke or transient ischemic attack within 6 months prior to enrolment.
7. Ongoing need for treatment with concomitant medication with any of the following
characteristics: known risk of Torsades de Pointes; substrate of CYP3A with narrow
therapeutic index; strong inducer of CYP3A and/or P-gp; strong inhibitor of BCRP;
and proton pump inhibitors that cannot be switched to alternative treatment prior to
enrolment.
8. Known human immunodeficiency virus (HIV) infection.
9. Acute or chronic hepatitis B or C infection.
10. Women who are pregnant or in the period of lactation.
11. Sexually active men and women of childbearing potential who are not willing to use
an effective contraceptive method during the study.
12. Judgement by the investigator that the patient should not participate in the study
if the patient is unlikely to comply with study procedures, restrictions and
requirements.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instiute Jules Bordet
Address:
City:
Brussels
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Thierry Berghmans
Email:
thierry.berghmans@bordet.be
Facility:
Name:
Centre Hospitalier d'Avignon
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Contact:
Last name:
Nicolas Cloarec
Email:
CLOAREC.Nicolas@ch-avignon.fr
Facility:
Name:
Caen - CHU
Address:
City:
Caen
Country:
France
Status:
Recruiting
Contact:
Last name:
Simon Deshayes
Email:
deshayes-si@chu-caen.fr
Facility:
Name:
Le Mans - CHG
Address:
City:
Le Mans
Country:
France
Status:
Recruiting
Contact:
Last name:
Olivier Molinier
Email:
omolinier@ch-lemans.fr
Facility:
Name:
Hôpital de Marseille
Address:
City:
Marseille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurent Greillier
Email:
Laurent.GREILLIER@ap-hm.fr
Facility:
Name:
Beaumont Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Jarushka Naidoo
Facility:
Name:
St James's Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Sinead Cuffe
Facility:
Name:
University Hospital Limerick
Address:
City:
Limerick
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Greg Korpanty
Facility:
Name:
University Hospital Waterford
Address:
City:
Waterford
Country:
Ireland
Status:
Recruiting
Contact:
Last name:
Paula Calvert
Facility:
Name:
Fondazione IRCCS Policlinico S. Matteo
Address:
City:
Pavia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesco Agustoni
Email:
f.agustoni@smatteo.pv.it
Facility:
Name:
Santa Maria della Misericordia Hospital
Address:
City:
Perugia
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giulio Metro
Email:
giulio.metro@ospedale.perugia.it
Facility:
Name:
Istituto Nazionale Tumori "Regina Elena"
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federico Cappuzzo
Email:
federico.cappuzzo@ifo.it
Facility:
Name:
AULSS2 Marca Trevigiana Treviso
Address:
City:
Treviso
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Adolfo Favaretto
Email:
adolfo.favaretto@aulss2.veneto.it
Facility:
Name:
Complejo Hospitalario Universitario a Coruña
Address:
City:
A Coruña
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Rosario Garcia Campelo
Facility:
Name:
Alicante University Hospital
Address:
City:
Alicante
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Bartomeu Massuti
Facility:
Name:
ICO Badalona - Hospital Germans Trias i Pujol
Address:
City:
Badalona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Teresa Morán
Facility:
Name:
Hospital de Basurto
Address:
City:
Bilbao
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Angeles Sala Gonzalez
Facility:
Name:
ICO Bellvitge -H. Duran i Reynals / H. Bellvitge
Address:
City:
L'Hospitalet De Llobregat
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ernest Nadal
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Manuel Dómine
Facility:
Name:
Hospital Universitario Puerta de Hierro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Mariano Provencio
Facility:
Name:
Hospital General Universitario de Valencia (University Hospital Valencia)
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ana Blasco
Facility:
Name:
Christie NHS Manchester
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Colin Lindsay
Email:
colin.lindsay1@nhs.net
Start date:
June 12, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
ETOP IBCSG Partners Foundation
Agency class:
Other
Collaborator:
Agency:
Mirati Therapeutics Inc.
Agency class:
Industry
Source:
ETOP IBCSG Partners Foundation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673187