Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.
This is an open-label, non-randomized, exploratory, phase II multi-centre clinical trial.The total sample size is 43 patients. The population to be included are unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients. Patients randomised will receive AMG510 (Sotorasib) 960mg once daily for 2 cycles (Q4W) in the induction phase and AMG510 (Sotorasib) 960 mg once daily (Q4W) in the treatment post-induction phase. Treatment post-induction phase only for patients with SD, PR or CR after induction treatment. This treatment will be administered until progression disease (PD), unacceptable toxicity, patient or physician's decision to discontinue or death. The primary objective is to assess the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 (PFS12) months according to Response Evaluation Criteria in Solid Tumors (RECIST) version PFS are defined as the time from inclusion until objective tumor progression or death. Patient accrual is expected to be completed within 5 years and a half, treatment is planned to extend for 1.5 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
AMG510 (Sotorasib) is small molecule that specifically and irreversibly inhibits the KRAS-G12C mutant protein. AMG510 (Sotorasib) finished product is presented as tablets containing 120mg and will be packaged in bottles of 120 tablets.
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGEfficacy of the treatment in terms of the Progression Free Survival (PFS)
PFS defined as the length of time from the date of end of post-induction treatment to the date of the first documented progression of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: From the date of first dose of induction treatment until 6 months
Overall response rate (ORR) of AMG510 (Sotorasib)
Overall response will be assessed per RECIST v1.1 criterion. ORR is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.
Time frame: From the date of the end of treatment until 12 months and 24 months
Overall Survival (OS) rate of treatment with AMG510 (Sotorasib)
OS defined as the length of time from either the date of diagnosis or the start of the treatment that patients diagnosed with the disease are still alive.
Time frame: From the date of the start of treatment until 12 and 24 months
Detect and collect the sites of first failure
Sites of the first failure defined as the first site of the body of documented relapse or progression of the lung cancer disease after a period of improvement.
Time frame: From the date of the start of treatment until the date of last follow up, assessed up to 24 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Time frame: From the subject written informed consent signature to 30 days from last dose of treatment.
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Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
RECRUITINGHospital Universitario Severo Ochoa
Leganés, Madrid, Spain
RECRUITINGHospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
RECRUITINGHospital de Son Espases
Palma de Mallorca, Mallorca, Spain
RECRUITINGHospital General Universitario de Alicante
Alicante, Spain
RECRUITINGHospital Universitari Quiron Dexeus
Barcelona, Spain
RECRUITINGHospital Universitari Vall d' Hebron
Barcelona, Spain
RECRUITINGHospital Parc Taulí
Barcelona, Spain
RECRUITINGHospital De Basurto
Bilbao, Spain
RECRUITING...and 10 more locations