A Study of Sotorasib in People With Non-Small Cell Lung Cancer
A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether sotorasib is safe and works for people with advanced non-small cell lung cancer. It is for adults whose cancer has a gene change called KRAS G12C and who have not had treatment since their cancer became advanced.
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.)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older and sign a form agreeing to join the study.
- Have lung cancer confirmed by a tissue sample that has spread or come back. A tumor or blood test must show the KRAS G12C gene change.
- Have no prior treatment for advanced cancer. The cancer must be measurable on scans.
- Be able to care for yourself, though normal activities or work may be hard. Blood counts, liver tests, and kidney tests must meet study limits.
- Decline initial chemotherapy and/or anti-PD-(L)1 immune treatment, or have cancer that worsened after these treatments for stage I–III lung cancer.
- Agree to tumor samples before treatment and 7–21 days after starting. You may still join if the study team later decides a sample would be unsafe.
- Women must be unable to become pregnant or follow the study's birth control rules. Those who can become pregnant need a negative blood pregnancy test.
- Men with partners who can become pregnant must follow condom and partner birth control rules. Men must not donate sperm during treatment or for at least 7 days after the last dose.
Who can't join
- Cancer in the brain that causes symptoms.
- Radiation treatment or major surgery within 1 week before study treatment, or anti-PD-(L)1 immune treatment for stage I–III cancer within 12 weeks.
- Side effects from past treatment that are still more than mild, or past treatment-related lung swelling that was more than mild.
- Severe heart failure, or a hospital stay for heart failure within the past 6 months.
- Digestive disease that prevents taking pills or absorbing nutrients, a need for nutrition through a vein, or uncontrolled bowel swelling.
- Certain positive hepatitis B or C tests, or other active or long-term liver disease. Some people with past or treated hepatitis may still qualify under the study's test rules.
- Taking part in another experimental drug or device study now or within the past 28 days, or receiving another experimental treatment.
- Use of certain medicines that affect how drugs are handled by the body without the study doctor's approval. The restricted period is at least 14 days before treatment and may be longer for some drugs.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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% * 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 * Serum creatinine \< 1.5 x ULN or if available, calculated or measured creatinine clearance \> 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 enrollment, a woman must be either: * 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 pregnancy * Of childbearing potential and practicing effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for subjects 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 to 6 months after the last dose of study drug is given. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not consider an acceptable contraceptive method * 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 intrauterine system \[IUS\], AND, a second method (e.g., condom with spermicidal foam/gel/film/cream/suppository or collusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/ cream/suppository) Subjects must agree to continue contraception throughout the study and continuing through at least 7 days after the last dose of study drug * 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 of birth control, as described above. * 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 contraception (i.e., established use of oral, injected or implanted hormonal methods of required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug. contraception; placement of an intrauterine device \[IUD\] or intrauterine system \[IUS\]). If the subject is vasectomized, he must still use a condom (with or without spermicide), but his female partner is not required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug. 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. * 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 * 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 whom either biopsy is ultimately deemed unsafe by the investigators/treatment team, will be allowed to participate in the study and will remain evaluable for the clinical endpoints.
Study sites (7)
NJ
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, NJ 07920Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, NJ 07748Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, NJ 07645Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Montvale
NY
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) · Commack, NY 11725Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Commack
- Memorial Sloan Kettering Westchester · Harrison, NY 10604Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Harrison
- Memorial Sloan Kettering Cancer Center · New York, NY 10065Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in New York
- Memorial Sloan Kettering Nassau · Uniondale, NY 11553Gregory Riely, MD, PhD · Study contact · 646-608-3913More trials in Uniondale