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Non-small Cell Lung Cancer Stage IIIPhase 2MERIT-lungNCT05398094

Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy

A Phase 2 study testing Sotorasib in people with Non-small Cell Lung Cancer Stage III and KRAS P.G12C, run by Fundación GECP at 20 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sotorasib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
20 sitesSpain
Study dates
21 Mar 2022to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 5. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.
  • 6. Having a life expectancy ≥ 12 weeks
Show all 24Show fewer
  • 7. Patients must be ineligible for concurrent chemo-radiotherapy because of:
  • Tumor size ≥ 5 cm and lymph node N2 involvement
  • The target lesion has to be bulky disease and/or more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function
  • Interstitial Lung diseases
  • Prior treatment with thoracic radiotherapy for any reason
  • Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront
  • 8. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease
  • 9. PET-CT positive mediastinic adenopathies must be histologically confirmed. Mediastinic involvement could be considered without histological test when no margin can be distinguished in the lymph node mass.
  • 10. Brain CT or MRI is mandatory
  • 11. Patients with at least 1 measurable lesion, as defined by RECIST v1.1.
  • 12. Adequate hematologic and organ function.
  • 13. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
  • 14. Willingness and ability to comply with scheduled visits and study procedures
  • 15. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment).
  • 16. For female patients of childbearing potential, agreement (by patient and/or partner) to usea highly effective form(s) of contraception that results in a low failure rate (< 1% per year)when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib). No hormonal methods and preferably barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
  • 17. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib).
  • 18. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrollment.
  • 19. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.

Who cannot join

  • 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
  • 5. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication
  • 6. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina
Show all 24Show fewer
  • 7. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval > 470ms
  • 8. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
  • 9. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization
  • 10. Patients with any concomitant and uncontrolled medical disorder
  • 11. Patients with vena cava syndrome
  • 12. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastaticdisease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray pleural effusion or too small to be safely punctured could be included.
  • 13. Prior treatment with anti-neoplasic drugs
  • 14. Malignancies other than NSCLC within 3 years prior to enrollment
  • 15. Women who are pregnant, lactating, or intending to become pregnant during the study.
  • 16. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.
  • 17. Patients with active hepatitis B or hepatitis C.
  • 18. Active tuberculosis.
  • 19. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
  • 20. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures.
  • 21. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug
  • 22. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study
  • 23. Use of strong inducers of CYP3A4 within 14 days of half-lives (whichever is longer) prior to study day 1
  • 24. Use of proton pump inhibitors within 14 days to study day

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Pereira contact

934302006

gecp@gecp.org

20 sites in 1 country

Spain20 sites, 20 recruiting

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Rosario García Campelo, MD

    Rosario García Campelo, MD

    Recruiting

  • Hospital General Universitario de Alicante

    Alicante, Alicante, 03010

    Bartomeu Massuti, MD

    Bartomeu Massuti, MD

    Recruiting

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Enric Carcereny, MD

    Enric Carcereny, MD

    Recruiting

  • Hospital Universitari Quiron Dexeus

    Barcelona, Barcelona, 08028

    Maria González, MD

    Maria González, MD

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

    Patricia Iranzo, MD

    Patricia Iranzo, MD

    Recruiting

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

    Julia Giner, MD

    Julia Giner, MD

    Recruiting

  • Hospital De Basurto

    Bilbao, Bilbao, 48013

    Mª Ángeles Sala, MD

    Mª Ángeles Sala, MD

    Recruiting

  • ICO Girona, Hospital Josep Trueta

    Girona, Girona, 17007

    Elia Sais, MD

    Elia Sais, MD

    Recruiting

  • Hospital Clínico San Cecilio De Granada

    Granada, Granada, 18016

    Silvia Sequero, MD

    Silvia Sequero, MD

    Recruiting

  • Complejo Hospitalario De Jaén

    Jaén, Jaén, 23007

    Ana Laura Ortega, MD

    Ana Laura Ortega, MD

    Recruiting

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid, 28911

    Ana López, MD

    Ana López, MD

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

    Sergio Vázquez, MD

    Sergio Vázquez, MD

    Recruiting

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

    Carlos Aguado, MD

    Carlos Aguado, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Manuel Dómine, MD

    Manuel Dómine, MD

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Mariano Provencio, MD

    Mariano Provencio, MD

    Recruiting

  • Hospital de Son Espases

    Palma de Mallorca, Mallorca, 07120

    Aitor Azkárate Martínez, MD

    Aitor Azkárate Martínez, MD

    Recruiting

  • Hospital Universitari Son Llatzer

    Palma de Mallorca, Palma de Mallorca, 07198

    Francisco Javier Garcia, MD

    Francisco Javier Garcia, MD

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

    Reyes Bernabé, MD

    Reyes Bernabé, MD

    Recruiting

  • Hospital General Universitario De Valencia

    Valencia, Valencia, 46014

    Paula Espinosa, MD

    Paula Espinosa, MD

    Recruiting

  • Hospital Universitario La Fe

    Valencia, Valencia, 46026

    Oscar Juan-Vidal, MD

    Oscar Juan-Vidal, MD

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Sotorasib
Keywords
Sotorasib, Unresectable, Chemo-radiotherapy, Lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotorasibDrug

    Also called AMG510

    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.

Study groups in NCT05398094
Study groupRoleWhat they receive
Experimental: Induction treatment + Post-Induction PhaseExperimentalPatients enrolled in the study 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 postinduction 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.
Receives: Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From the date of first dose of induction treatment until 6 months

Secondary outcomes (4)

  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.

    Measured: From the date of the end of treatment until 12 months and 24 months

  2. 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.

    Measured: From the date of the start of treatment until 12 and 24 months

  3. 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.

    Measured: From the date of the start of treatment until the date of last follow up, assessed up to 24 months

  4. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.

    Measured: From the subject written informed consent signature to 30 days from last dose of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start21 Mar 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05398094
Sponsor's protocol ID
GECP 20/10_MERIT-lung
Other IDs
2021-004576-34
Acronym
MERIT-lung
Status last verified
Apr 2026
First submitted
13 May 2022
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotorasib in people with Non-small Cell Lung Cancer Stage III and KRAS P.G12C, run by Fundación GECP at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Pereira (934302006, gecp@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of the treatment in terms of the Progression Free Survival (PFS) (time frame: From the date of first dose of induction treatment until 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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