WithdrawnPhase 2NCT05400577
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSotorasib, 960 mg, oral daily dose for 4 weeks (28 days)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 17, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Fox Chase Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Fox Chase Cancer Center
Interventions being studied
Drug: Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 1. Patients must have non-squamous NSCLC with KRAS G12C mutation identified through molecular testing (local assessment), AJCC 8 stages Ib, IIa, IIb, IIIa (single nodal station) and assessment by a thoracic surgeon that the patient is potentially resectable and physiologically operable. Lymph nodes should be pathologically staged, if feasible, prior to enrollment. 2. No prior NSCLC anticancer therapy 3. Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v. 1.1 as described in detail in section 11.0. 4. Age \> 18 years. 5. ECOG performance status 0 or 1 6. Must have the ability to take oral medications and willing to record daily adherence to investigational product utilizing a sponsor-provided dosing diary 7. Subjects must have normal organ and marrow function as defined below
  • Absolute neutrophil count \> 1,000/mcL
  • Platelets \> 75,000/mcL
  • Total bilirubin \< 1.5 x ULN (\< 2.0 x ULN for subjects with documented Gilbert's syndrome or \< 3.0 x ULN for whom the indirect bilirubin level suggests an extrahepatic source of elevation)
  • AST/ALT (SGOT/SGPT) \< 2.5 times institutional normal limits
  • Creatinine clearance Estimated glomerular filtration rate based on MDRD (Modification of Diet in Renal Disease) calculation \>=30 ml/min/1.73 m2
  • Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x ULN, OR International normalized ratio (INR) \<1.5 or within target range if on anticoagulation therapy 8. Ability to understand and willingness to sign a written informed consent and HIPAA consent document
Reasons someone may not be able to joinExclusion criteria

1. Any prior therapy directed at NSCLC and Previous treatment with a direct KRAS G12C inhibitor. 2. Patients receiving any other investigational agents. 3. Patients with uncontrolled intercurrent illness, that would in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, informed consent, procedures, primary endpoint or study completion. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients with non-invasive malignancies (e.g. in situ cervical cancer) ARE eligible. 4. History of allergic reactions attributed to compound of similar chemical or biologic composition to the agent used in this study. 5. Patients receiving any medications or substances that are strong inhibitors or inducers of sotorasib ineligible. Please refer to section 5.2 for details about excluded therapies and restrictions. 6. Major surgery (as assessed by treating clinician) within 28 days of study registration. 7. Pregnant or breast feeding. Refer to section 4.4 for further detail.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 17, 2023. Always confirm current availability with the study team.

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