Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación GECP
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Male or female, aged ≤ 80 years old
2. ECOG performance status of 0-1
3. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.
4. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.
Disqualifiers
1. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations
2. Weight loss >10% within the previous 3 months
3. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0
4. Major surgery within 28 days of study day 1
Trial design
Design model
Single group
Treatments tested in this trial
Sotorasib
DrugAMG510 (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.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Experimental: Induction treatment + Post-Induction PhaseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy 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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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.Sponsors and contacts
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Source ClinicalTrials.gov