NCT06582771
Recruiting
Phase 2
A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center13 sites in 1 country39 target enrollmentStarted: August 30, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 39
- Locations
- 13
- Primary Endpoint
- Response to therapy
Overview
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.)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%
- •Adequate organ function
- •Hemoglobin ≥ 9\^9 g/dL
- •Platelets ≥ 75 x 10\^9/L
- •Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
Exclusion Criteria
- •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.
Arms & Interventions
Sotorasib
Experimental
All patients will start at sotorasib 960 mg (8 pills) daily within 7 days of completion of the pretreatment tumor biopsy.
Intervention: Sotorasib (Drug)
Outcomes
Primary Outcomes
Response to therapy
Time Frame: within 6 month of therapy
will be assessed with serial CT chest/abdomen/pelvis every 2 cycles (6 weeks), with response evaluated by RECIST 1.1
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (13)
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