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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

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