NCT05398094

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
33mo left

Started Mar 2022

Longer than P75 for phase_2

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2022Dec 2028

Study Start

First participant enrolled

March 21, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

May 13, 2022

Last Update Submit

April 29, 2026

Conditions

Non-small Cell Lung Cancer Stage IIIKRAS P.G12C

Keywords

SotorasibUnresectableChemo-radiotherapyLung cancer

Outcome Measures

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

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

Secondary Outcomes (4)

  • Overall response rate (ORR) of AMG510 (Sotorasib)

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

  • Overall Survival (OS) rate of treatment with AMG510 (Sotorasib)

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

  • Detect and collect the sites of first failure

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

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

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

Study Arms (1)

Experimental: Induction treatment + Post-Induction Phase

EXPERIMENTAL

Patients 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.

Drug: Sotorasib

Interventions

SotorasibDRUG

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.

Also known as: AMG510
Experimental: Induction treatment + Post-Induction Phase

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female, aged ≤ 80 years old
  • \. ECOG performance status of 0-1
  • \. 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.
  • \. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.
  • \. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.
  • \. Having a life expectancy ≥ 12 weeks
  • \. 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
  • \. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease
  • \. 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.
  • \. Brain CT or MRI is mandatory
  • +9 more criteria

You may not qualify if:

  • \. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations
  • \. Weight loss \>10% within the previous 3 months
  • \. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0
  • \. Major surgery within 28 days of study day 1
  • \. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication
  • \. 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
  • \. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \> 470ms
  • \. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
  • \. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization
  • \. Patients with any concomitant and uncontrolled medical disorder
  • \. Patients with vena cava syndrome
  • \. 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.
  • \. Prior treatment with anti-neoplasic drugs
  • \. Malignancies other than NSCLC within 3 years prior to enrollment
  • \. Women who are pregnant, lactating, or intending to become pregnant during the study.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Parc Taulí

Barcelona, Barcelona, 08208, Spain

RECRUITING

Hospital De Basurto

Bilbao, Bilbao, 48013, Spain

RECRUITING

ICO Girona, Hospital Josep Trueta

Girona, Girona, 17007, Spain

RECRUITING

Hospital Clínico San Cecilio De Granada

Granada, Granada, 18016, Spain

RECRUITING

Complejo Hospitalario De Jaén

Jaén, Jaén, 23007, Spain

RECRUITING

Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital de Son Espases

Palma de Mallorca, Mallorca, 07120, Spain

RECRUITING

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital General Universitario De Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

sotorasib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mariano Provencio, MD

    Fundación GECP President

    STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

934302006gecp@gecp.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 31, 2022

Study Start

March 21, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(20)