Status:
UNKNOWN
K-SAB Trial - Sotorasib Followed by SBRT to 1-3 Lesions in Advanced NSCLC With KRASG12C Mutation
Lead Sponsor:
Karolinska University Hospital
Collaborating Sponsors:
Sahlgrenska University Hospital
Amgen
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 KRASG...
Detailed Description
Eligible subjects are those with a diagnosis of advanced KRASG12C mutated NSCLC who have received at least one line of standard medical treatment with immuno(chemo)therapy. The subjects start with so...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Histological or cytological confirmed advanced NSCLC
- KRASG12C mutation
- Previous at least one line of treatment with immune- or/and chemotherapy or contraindications for immune- and/or chemotherapy.
- Adequate organ function to tolerate sotorasib (see section 6.1 and 6.2 for details)
- 2-5 lesions technically amenable to SBRT with 15 Gy x 3, 10 Gy x 5, or 7-8 Gy x 5.
- Adequate organ function to tolerate SBRT:
- o Fulfilment of dose constraints to adequate organs at risk
- ECOG performance status (PS) 0-1
- FEV1 ≥1 litre (only applicable for lung targets)
- Age ≥ 18 years
- Measurable lesions according to RECIST
- Main exclusion criteria:
- Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid) or metastases in the central nervous system
- Previous RT for any cancer within the last 3 years possibly interfering with the planned RT within this study
- Life expectancy of less than 6 months
- Inability to understand given information or undergo study procedures according to protocol
- Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis
- Woman who is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib
- Women of childbearing potential (WOCBP) unwilling to use a highly effective method of contraception during treatment and for an additional 7 days after the last dose of sotorasib. WOCBP using hormonal contraceptives should also use a barrier method
- WOCBP with a positive pregnancy test assessed at screening or day 1 by a serum pregnancy test and/or urine pregnancy test
- Centrally located pulmonary target (i.e., within 1 cm of the main bronchi or intermedius bronchus) and targets located within 1 cm of the gut, for SBRT
- Use of known cytochrome P450 (CYP) 3A4 or P-gp sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator
- Use of strong inducers of CYP3A4 (including herbal supplements such as St. John´s wort) within 14 days or 5 half-lives, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator
- Use of proton pump inhibitors (PPIs) within 3 days or H2-receptor antagonists within 1 day prior to study intervention
- Use of warfarin. Use of Direct-Acting Oral Anticoagulants (DOAC) within 14 days or 5 half-lives, whichever is longer, prior to study day 1. Other anticoagulation may be allowed with principal investigator approval.
Exclusion
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06127940
Start Date
October 15 2023
End Date
January 1 2026
Last Update
November 13 2023
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Solna, Sweden, 17176