Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-08 @ 11:00 PM
Study NCT ID:
NCT05398094
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2022-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Sponsor:
Fundación GECP
Organization:
Study Overview
Official Title:
Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERIT-lung
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-004576-34 | EUDRACT_NUMBER | None | View |