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New treatment option for Non Small Lung Cancer
Official title A Study of Sotorasib in People With Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06582771
What this study is testing
What is Sotorasib?
Sotorasib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non small lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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%
- 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; people with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
- Serum creatinine \ 30 mL/min/1.73 m\^2 In addition, patients must:
- Be willing to undergo pre-treatment and day 7-21 on-treatment tumor biopsies
- Decline first-line chemotherapy and/or anti-PD-(L)1 therapy, or previously have experienced disease progression after adjuvant or consolidation chemotherapy or anti-PD-(L)1 therapy for early stage (I-III) NSCLC Before...
- Not of childbearing potential: premenarchal; postmenopausal (\>45 years of age with amenorrhea for at least 12 months); post-hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of...
- Of childbearing potential and practicing effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for people participating in clinical studies, as described below:
- Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject), which is defined as refraining from heterosexual intercourse during the entire period of the study, including up...
- Have a sole partner who is vasectomized
- Practicing 2 methods of contraception, including one highly effective method (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of intrauterine device [IUD] or...
- NOTE: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin a highly effective method...
- A woman of childbearing potential must have a negative serum (b-human chorionic gonadotropin [b-hCG]) at Screening
- A man who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of...
- 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...
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) o NOTE: people with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative...
- 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...
- 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
- Patients who do not agree to pre-treatment and on-treatment tumor biopsies during the informed consent process will be excluded from the study. Patients who agree to pre-treatment and on-treatment tumor biopsies, but in...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.