NCT05400577

Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC

Neoadjuvant Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA Non-Small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm study, conducted at two centers, of neoadjuvant sotorasib in treatment naïve patients with stage Ib-IIIa NSCLC. The study will accrue 25 patients in all. Patients must have been deemed surgically resectable and physiologically fit for surgery by a thoracic surgeon prior to enrollment.

Detailed description

There will be a two-part consent, including consent for KRAS testing and consent for treatment on trial. Testing for a KRAS G12C mutation in patients with resectable, stage Ib-IIIa NSCLC is currently not standard of care. Patients who are otherwise felt to be good candidates for this study, after review in multidisciplinary thoracic tumor board, will be screened for KRAS G12C after signing informed consent for screening. Next generation sequencing will be performed on standard of care diagnostic biopsy tissue for EGFR (standard of care) as well as KRAS mutations. Patients who are found to have a KRAS G12C mutation, will be eligible for the study intervention. This is a single arm study, conducted at two centers, of neoadjuvant sotorasib in treatment naïve patients with stage Ib-IIIa NSCLC. The study will accrue 25 patients in all. Patients must have been deemed surgically resectable and physiologically fit for surgery by a thoracic surgeon prior to enrollment. In addition, every patient will be discussed in multidisciplinary thoracic tumor board prior to enrollment, with medical oncology, radiation oncology and surgical oncology physicians present, to determine the optimal treatment approach. All patients must undergo baseline tumor staging, including pretreatment biopsy, pathological evaluation of mediastinal lymph nodes (if indicated) by means of bronchoscopy or mediastinoscopy, chest and brain imaging (CT chest with contrast and CT head with contrast or MRI brain); PET and diagnostic CT chest will be repeated within 7 days before surgery. Subjects will take sotorasib dosed at 960 mg daily by mouth with or without food for 4 weeks (28 days) prior to surgery. Changes in tumor size will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. The primary objective of this study is to determine the rate of MPR. Primary tumors will be assessed, using the recently published International Association for the Study of Lung Cancer guidelines, for percentage of residual viable tumor identified on routine hematoxylin and eosin (H\&E) staining, and tumor with no more than 10% viable tumor cells will be considered to have a MPR. Once patients have completed neoadjuvant therapy, they will undergo surgery, followed by standard of care adjuvant therapy as deemed fit by their treating physician. Data on disease assessment during patients' standard of care visits post-surgery will be collected to evaluate their DFS. All patients will be accrued in 18 months.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)	Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-01-01
• Completion: 2024-02-01
• First posted: 2022-06-01
• Last updated: 2023-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study