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K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation

NCT06127940 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-13

No results posted yet for this study

Summary

The goal of this interventional study is to learn about the combination of sotorasib and stereotactic radiation therapy (SBRT) in patients with metastatic non-small cell lung cancer (NSCLC) with KRASG12C mutations. The main question it aims to answer is:

• can SBRT be safely delivered in patients treated with sotorasib

Participants will be treated with sotorasib for an 8-week-induction period and if the patient has stable disease or partial response, 1-3 of the remaining lesions will be irradiated with SBRT and sotorasib will then be contiuned after irradiation. The patients will then be followed and evaluated for toxicity to identify if grade 3-5 toxicity attributed to SBRT occurs within 6 months post SBRT. Tumour effects measured according to RECIST v1.1 will also be evaluated.

Conditions

  • Non-small Cell Lung Cancer Metastatic

Interventions

RADIATION

Stereotactic body radiation therapy (SBRT)

SBRT is delivered using institutional standard dosing while sotorasib is withheld during radiation.

DRUG

Temporary Stopping

Temporary stop of sotorasib during SBRT

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Amgen

    collaborator INDUSTRY

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Karin Lindberg, MD, PhD · Karolinska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2025-06-01
Completion
2026-01-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06127940 on ClinicalTrials.gov