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Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

NCT05311709•Vestre Viken Hospital Trust

View on ClinicalTrials.gov

Summary

A single-arm, multicentre trial to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations.

Detailed Description

A single-arm multi-institutional phase II study to investigate sotorasib in KRASG12C-mutated non-small cell lung cancer stage III/IV not amenable for curative treatment including patients with comorbidities, and to provide translational knowledge regarding mechanism of relapse and differences in responses, including differences among patients with different co-occurring mutations. The aim is to investigate whether treatment with sotorasib will provide significant objective response rates in predefined KRASG12C-mutated non-small cell lung cancer patients that are not typically included in phase III-studies. Furthermore, the trial will explore whether patients in performance status ECOG 2 may benefit from sotorasib. In this study, a relevant number of sotorasib-naïve patients (n=100) will be treated with sotorasib and followed for efficacy and side effects. MRI-scans both at base-line and regularly during therapy will give data on intracranial efficacy. Eligible patients will be previously treated with at least 1 line standard (chemo)immunotherapy, or deemed in-eligible for standard (chemo)immunotherapy. In part II of the study, comprehensive analyses of biological samples taken pretreatment, and post-progression will provide novel information about resistance mechanisms on sotorasib. Furthermore, analyses of biopsies taken at partial response (estimated to be performed in 25-30% of cases) may potentially also characterize non-eradicated residual cells after achieved response. The post-progression biopsies may indicate the optimal next-line therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated, written informed consent.
•Age \> 18 years.
•Histologically or cytologically documented NSCLC stage III/IV not amenable for curative treatment. Patients that have received systemic adjuvant therapy for non-metastatic disease in the past will need a new biopsy before inclusion if no biopsy acquired after adjuvant therapy is available.
•Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method.
•Subjects will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable for curative treatment. Prior treatment must include checkpoint inhibitor for advanced or metastatic disease, either given alone or in combination with chemotherapy unless the subject has a medical contraindication to one of the required therapies.
•1. Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
•2. Disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy.
•At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1. Brain metastases are not regarded measurable.
•Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
•* Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
+20 more criteria

Exclusion Criteria

•Previously identified driver mutation (according to local standard of care or guidelines) other than KRASG12C for which an approved therapy is available (including EGFR, ALK, etc).
•▪ The following comorbidities are ineligibility criteria: i. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
•ii. Previous malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry.
•iii. Significant gastrointestinal disorder that results in requirement for intravenous alimentation, or inability to take oral medication.
•Use of known cytochrome P450 (CYP) 3A4 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.
•History of hypersensitivity of active or inactive excipients of sotorasib or drugs with a similar chemical structure or class to sotorasib.
•Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
•Previous enrolment in the present study or previous treatment with sotorasib.
•Any unresolved toxicities from prior therapy greater than CTCAE grade 2, unless discussed with Sponsor.
•Women who are pregnant or breast-feeding, or have a positive (urine or serum) pregnancy test prior to study entry
+2 more criteria

Locations (1)

Vestre Viken Health Trust

Drammen, Akershus, Norway

Key Dates

Start Date

May 30, 2022

Primary Completion Date

October 1, 2024

Completion Date

March 1, 2025

Last Updated

November 9, 2023

Enrollment

100

ESTIMATED participants

Conditions

Lung CancerNSCLC, Stage IIINSCLC Stage IVLung Cancer Stage IVMutationCancerCancer, Lung

Interventions

sotorasib

DRUG

Contacts

Odd Terje Brustugun, MD, PhD

CONTACT

+4732862464 otr@vestreviken.no

Inger-Johanne Eide, MD, PhD

CONTACT

+4799713251 ingei@vestreviken.no

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities

Inclusion Criteria

Exclusion Criteria

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