Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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.

Locations
Other Locations
Spain
Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital General Universitario de Alicante
RECRUITING
Alicante
ICO Badalona, Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Parc Taulí
RECRUITING
Barcelona
Hospital Universitari Quiron Dexeus
RECRUITING
Barcelona
Hospital Universitari Vall d' Hebron
RECRUITING
Barcelona
Hospital De Basurto
RECRUITING
Bilbao
ICO Girona, Hospital Josep Trueta
RECRUITING
Girona
Hospital Clínico San Cecilio De Granada
RECRUITING
Granada
Complejo Hospitalario De Jaén
RECRUITING
Jaén
Hospital Universitario Severo Ochoa
RECRUITING
Leganés
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital de Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitari Son Llatzer
RECRUITING
Palma De Mallorca
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital General Universitario De Valencia
RECRUITING
Valencia
Hospital Universitario La Fe
RECRUITING
Valencia
Contact Information
Primary
Eva Pereira
gecp@gecp.org
934302006
Time Frame
Start Date: 2022-03-21
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 19
Treatments
Experimental: Experimental: Induction treatment + Post-Induction Phase
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.
Authors
Sponsors
Leads: Fundación GECP

This content was sourced from clinicaltrials.gov