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Brief Title: Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status
Official Title: A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status
Study ID: NCT05673187
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Instiute Jules Bordet, Brussels, , Belgium
Centre Hospitalier d'Avignon, Avignon, , France
Caen - CHU, Caen, , France
Le Mans - CHG, Le Mans, , France
Hôpital de Marseille, Marseille, , France
Beaumont Hospital, Dublin, , Ireland
St James's Hospital, Dublin, , Ireland
University Hospital Limerick, Limerick, , Ireland
University Hospital Waterford, Waterford, , Ireland
Fondazione IRCCS Policlinico S. Matteo, Pavia, , Italy
Santa Maria della Misericordia Hospital, Perugia, , Italy
Istituto Nazionale Tumori "Regina Elena", Rome, , Italy
AULSS2 Marca Trevigiana Treviso, Treviso, , Italy
Complejo Hospitalario Universitario a Coruña, A Coruña, , Spain
Alicante University Hospital, Alicante, , Spain
ICO Badalona - Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital de Basurto, Bilbao, , Spain
ICO Bellvitge -H. Duran i Reynals / H. Bellvitge, L'Hospitalet De Llobregat, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Madrid, , Spain
Hospital General Universitario de Valencia (University Hospital Valencia), Valencia, , Spain
Christie NHS Manchester, Manchester, , United Kingdom
Name: Jarushka Naidoo
Affiliation: Beaumont RCSI Cancer Centre, Beaumont Hospital
Role: STUDY_CHAIR