A Study of Sotorasib in People With Non-Small Cell Lung Cancer

NCT06582771 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 24-049
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a "first-line therapy" since their cancer became advanced.)

Conditions

Non Small Lung Cancer

Keywords

Sotorasib; advanced KRAS G12C-mutant; 24-049

Outcome Measures

Primary Outcomes (1)

• Response to therapy

  will be assessed with serial CT chest/abdomen/pelvis every 2 cycles (6 weeks), with response evaluated by RECIST 1.1

  within 6 month of therapy

Study Arms (1)

Sotorasib

EXPERIMENTAL

All patients will start at sotorasib 960 mg (8 pills) daily within 7 days of completion of the pretreatment tumor biopsy.

Drug: Sotorasib

Interventions

Sotorasib DRUG

Sotorasib 960 mg (8 pills) daily

Sotorasib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Biopsy-proven metastatic or recurrent non-small cell lung cancer
• KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing
• No prior therapy in the advanced setting
• Measurable disease per RECIST 1.1
• Karnofsky performance status (KPS) ≥ 70%
• Age ≥ 18
• Adequate organ function
• Hemoglobin ≥ 9\^9 g/dL
• Platelets ≥ 75 x 10\^9/L
• Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
• AST \< 3 x ULN (if liver metastases are present, \< 5 x ULN)
• ALT \< 3 x ULN (if liver metastases are present, \< 5 x ULN)
• Alkaline phosphatase \< 2 x ULN (if liver or bone metastases are present,\< 3 xULN)
• Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits

You may not qualify if:

• Symptomatic brain metastases
• Any radiotherapy within 1 week of starting treatment on protocol
• Any major surgery within 1 week of starting treatment on protocol
• Exposure to prior adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy for stage I-III disease within 12 weeks of start of initiation of sotorasib
• Unresolved \> grade 1 toxicity from any previous treatment
• Prior history of \> grade 1 pneumonitis from any previous treatment
• Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, uncontrolled inflammatory GI disease (eg, Crohn's disease, ulcerative colitis)
• Positive hepatitis B (hepatitis B virus \[HBV\]) surface antigen (HBsAg) o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
• Positive hepatitis C antibody (anti-HCV)
• o NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
• Other clinically active or chronic liver disease
• Currently enrolled in another investigational device or drug study, or less than 28 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
• Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives (whichever is longer) 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 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 P-gp substrates 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

sotorasib

Study Officials

• Gregory Riely, MD, PhD

  Memorial Sloan Kettering Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Riely, MD, PhD

CONTACT

646-608-3913; rielyg@mskcc.org

Kathryn Arbour, MD

CONTACT

646-608-3792

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a phase 2 study with a single cohort.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)