Actively Recruiting
Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy
Led by Fundación GECP · Updated on 2026-04-30
19
Participants Needed
20
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMG510 (Sotorasib) in adults with unresectable stage III non-small cell lung cancer (NSCLC) that has the KRAS p.G12C mutation and who cannot have chemo-radiotherapy. This open-label, non-randomized, phase II study aims to assess the treatment's effect on progression-free survival at 12 months in 43 patients across multiple centers. The trial includes patients with specific lung cancer stages and medical conditions preventing standard chemo-radiotherapy. Participants will receive AMG510 tablets at a dose of 960 mg once daily for two 4-week cycles during an induction phase. Those with stable disease, partial response, or complete response after induction will continue AMG510 once daily during a post-induction treatment phase. Treatment continues until disease progression, unacceptable side effects, a decision to stop by patient or doctor, or death. The study plans patient enrollment over five and a half years, with treatment lasting up to 1.5 years. During the trial, participants will undergo regular assessments including PET-CT scans, brain imaging, and tumor evaluations based on standard criteria. Researchers will monitor progression-free survival, overall response rate, overall survival, sites of disease failure, and treatment side effects. Safety will be observed from consent through 30 days after treatment ends. Follow-up will continue for two years after treatment to track long-term outcomes and survival.
CONDITIONS
Brief 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 0-1
- Histologically or cytologically confirmed unresectable stage III (IIIA-N2, IIIB, IIIC) non-small cell lung cancer
- Documented KRAS p.G12C mutation by solid or liquid biopsy prior to enrollment
- No prior treatment for unresectable stage III NSCLC
- Life expectancy of at least 12 weeks
- Ineligible for concurrent chemo-radiotherapy due to tumor size, lung volume affected, pulmonary function, interstitial lung diseases, prior thoracic radiotherapy, or tumor committee decision
- Mandatory baseline PET-CT confirming absence of distant disease and unresectable disease
- Histological confirmation of PET-CT positive mediastinal lymph nodes unless undistinguishable mass
- Brain CT or MRI required
- At least one measurable lesion per RECIST v1.1
- Adequate hematologic and organ function
- Written informed consent provided
- Willingness and ability to comply with study visits and procedures
- Negative pregnancy test within 14 days prior to enrollment for females of childbearing potential
- Agreement to use highly effective contraception during and 7 days after treatment for females and males 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, ALK translocations, or ROS1 mutations
- Weight loss over 10% in past 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
- Significant cardiovascular disease including recent myocardial infarction, unstable angina, or arrhythmias
- Cardiac dysrhythmias grade 2 or higher or QTcF interval >470 ms
- Severe infections within 4 weeks prior to randomization
- Use of oral or IV antibiotics within 2 weeks prior to randomization
- Any uncontrolled medical disorder
- Vena cava syndrome
- Malignant pleural or pericardial effusion suggestive of metastatic disease
- Prior anti-cancer drug treatment
- Other malignancies within 3 years prior to enrollment
- Pregnant, lactating, or intending pregnancy during study
- Positive HIV test
- Active hepatitis B or C
- Active tuberculosis
- Any condition contraindicating investigational drug use or affecting study results
- Conditions interfering with understanding or compliance with study
- Known or suspected allergy to drugs similar to AMG510
- Significant laboratory abnormalities or disorders 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive induction treatment with AMG510 (Sotorasib) 960mg once daily for 2 cycles (each cycle lasting 4 weeks).
Visits every 4 weeks during induction (2 visits)
Duration - Until disease progression or discontinuation
Participants with stable disease, partial or complete response after induction continue AMG510 (Sotorasib) 960mg once daily until disease progression, unacceptable toxicity, decision to discontinue, or death.
Regular visits every 4 weeks during treatment post-induction
Duration - Up to 2 years
Participants are followed for survival and safety outcomes after treatment ends.
Periodic visits up to 2 years post-treatment
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
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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