Actively Recruiting
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Led by Fundación GECP · Updated on 2026-04-30
19
Participants Needed
20
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 80 years or younger
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed unresectable stage III NSCLC (IIIA-N2, IIIB, IIIC)
- Documented KRAS p.G12C mutation by solid or liquid biopsy
- No prior treatment for unresectable stage III NSCLC
- Life expectancy of at least 12 weeks
- Ineligible for concurrent chemo-radiotherapy due to tumor size, lymph node involvement, lung volume radiation exposure, pulmonary function, interstitial lung diseases, prior thoracic radiotherapy, or tumor committee decision
- Baseline PET-CT confirming absence of distant disease and unresectable status
- Histological confirmation of PET-CT positive mediastinal lymph nodes unless indistinguishable margins
- Mandatory brain CT or MRI
- At least one measurable lesion per RECIST v1.1
- Adequate blood and organ function
- Written informed consent
- Willingness and ability to comply with study visits and procedures
- Negative pregnancy test for females of childbearing potential within 14 days prior to enrollment
- Use of highly effective contraception during and for 7 days after treatment for females and males with partners of childbearing potential
- QTc interval ≤470 msec in females and ≤450 msec in males based on average of three ECGs
You will not qualify if you...
- Known sensitizing mutations in EGFR gene, ALK translocations, or ROS1 mutations
- Weight loss greater than 10% in the last 3 months
- Uncontrolled sensory neuropathy grade 2 or higher
- Major surgery within 28 days before study start
- Significant gastrointestinal disorders affecting absorption or oral medication intake
- Significant cardiovascular disease including NYHA class II or higher, recent myocardial infarction, unstable arrhythmias, or unstable angina
- Ongoing cardiac dysrhythmias grade 2 or higher, uncontrolled atrial fibrillation, or QTcF interval over 470 ms
- Severe infections within 4 weeks before randomization
- Use of therapeutic oral or intravenous antibiotics within 2 weeks before randomization
- Any uncontrolled medical disorder
- Vena cava syndrome
- Malignant pleural or pericardial effusion or exudates suggestive of metastasis
- Prior treatment with anti-cancer drugs
- Other malignancies within 3 years prior to enrollment
- Pregnant, lactating, or intending pregnancy during the study
- Positive HIV test
- Active hepatitis B or C
- Active tuberculosis
- Any other disease or condition that contraindicates investigational drug use or affects study results
- Conditions interfering with understanding or following study procedures
- Known or suspected allergy to similar drugs
- Significant other disorders or lab findings making participation undesirable
- Use of strong CYP3A4 inducers within 14 days prior to study
- Use of proton pump inhibitors within 14 days prior to study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
Actively Recruiting
2
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Actively Recruiting
3
Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, Spain, 08028
Actively Recruiting
4
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
5
Hospital Parc Taulí
Barcelona, Barcelona, Spain, 08208
Actively Recruiting
6
Hospital De Basurto
Bilbao, Bilbao, Spain, 48013
Actively Recruiting
7
ICO Girona, Hospital Josep Trueta
Girona, Girona, Spain, 17007
Actively Recruiting
8
Hospital Clínico San Cecilio De Granada
Granada, Granada, Spain, 18016
Actively Recruiting
9
Complejo Hospitalario De Jaén
Jaén, Jaén, Spain, 23007
Actively Recruiting
10
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain, 15006
Actively Recruiting
11
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003
Actively Recruiting
12
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28911
Actively Recruiting
13
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
14
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
15
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
16
Hospital de Son Espases
Palma de Mallorca, Mallorca, Spain, 07120
Actively Recruiting
17
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain, 07198
Actively Recruiting
18
Hospital Universitario Virgen Del Rocio
Seville, Sevilla, Spain, 41013
Actively Recruiting
19
Hospital General Universitario De Valencia
Valencia, Valencia, Spain, 46014
Actively Recruiting
20
Hospital Universitario La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Research Team
E
Eva Pereira
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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