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Non Small Lung CancerPhase 2NCT06582771

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

A Phase 2 study testing Sotorasib in people with Non Small Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Lung Cancer
What is being tested?
Sotorasib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
7 sitesUnited States
Study dates
30 Aug 2024to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gregory Riely, MD, PhD contact

646-608-3913

rielyg@mskcc.org

Kathryn Arbour, MD contact

646-608-3792

7 sites in 1 country

United States7 sites, 7 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Gregory Riely, MD, PhD, 646-608-3913

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer

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.)

Being tested
Sotorasib
Keywords
Sotorasib, advanced KRAS G12C-mutant, 24-049

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotorasibDrug

    Sotorasib 960 mg (8 pills) daily

Study groups in NCT06582771
Study groupRoleWhat they receive
SotorasibExperimentalAll patients will start at sotorasib 960 mg (8 pills) daily within 7 days of completion of the pretreatment tumor biopsy.
Receives: Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: within 6 month of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2024
  2. Study start30 Aug 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This will be a phase 2 study with a single cohort.
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06582771
Sponsor's protocol ID
24-049
Status last verified
Sep 2026
First submitted
30 Aug 2024
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sotorasib in people with Non Small Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory Riely, MD, PhD (646-608-3913, rielyg@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to therapy (time frame: within 6 month of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06582771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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Clinical Trial NCT06582771 | AzTrials