Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Southwest Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Drug: Sotorasib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Participants must be assigned to S1900E. Assignment to S1900E is determined by the
   LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker
   eligibility for S1900E is based on the identification of a KRAS^G12C mutation

   - Participants must have confirmed stage IV or recurrent non-squamous non-small cell
   lung cancer (NSCLC). Mixed histology NSCLC with less than 50% squamous component is
   allowed

   - Participants must have measurable disease documented by computed tomography (CT) or
   magnetic resonance imaging (MRI). The CT from a combined positron emission tomography
   (PET)/CT may be used to document only non-measurable disease unless it is of
   diagnostic quality. Measurable disease must be assessed within 28 days prior to
   sub-study registration. Pleural effusions, ascites and laboratory parameters are not
   acceptable as the only evidence of disease. Non-measurable disease must be assessed
   within 42 days prior to sub-study registration. Participants whose only measurable
   disease is within a previous radiation therapy port must demonstrate clearly
   progressive disease (in the opinion of the treating investigator) prior to
   registration

   - Participants must have a CT or MRI scan of the brain to evaluate for central nervous
   system (CNS) disease within 42 days prior to sub-study registration

   - Participants with known human immunodeficiency virus (HIV) infection must be receiving
   anti-retroviral therapy and have an undetectable viral load at their most recent viral
   load test within 6 months prior to sub-study registration

   - Participants with EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion,
   ROS1 gene rearrangement, or BRAF V600E mutation must have progressed following all
   standard of care targeted therapy

   - Participants with spinal cord compression or brain metastases must have received local
   treatment to these metastases and remained clinically controlled and asymptomatic for
   at least 7 days following stereotactic radiation and/or 14 days following whole brain
   radiation, and prior to sub-study registration

   - Participants must have received at least one line of systemic treatment for stage IV
   or recurrent NSCLC

   - Participants must have progressed (in the opinion of the treating physician) following
   the most recent line of systemic therapy for NSCLC

   - Participants must have recovered (=< grade 1) from side effects of prior therapy. The
   exception is if a side effect from a prior treatment is known to be permanent without
   expected further recovery or resolution (i.e., endocrinopathy from immunotherapy or
   cisplatin neurotoxicity)

   - Participants must be able to swallow tablets whole

   - Pre-study history and physical exam must be obtained within 28 days prior to sub-study
   registration

   - Absolute neutrophil count (ANC) >= 1,500/uL obtained within 28 days prior to sub-study
   registration

   - Platelet count >= 75,000/uL obtained within 28 days prior to sub-study registration

   - Hemoglobin >= 9 g/dL obtained within 28 days prior to sub-study registration

   - Serum bilirubin =< institutional upper limit of normal (IULN) within 28 days prior to
   sub-study registration

   - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 x IULN within
   28 days prior to sub-study registration. For participants with liver metastases, and
   ALT and AST must be =< 5 x IULN

   - Participants must have a serum creatinine =< 1.5 x IULN or calculated creatinine
   clearance >= 50 mL/min using the following Cockcroft-Gault Formula. This specimen must
   have been drawn and processed within 28 days prior to sub-study registration

   - Participants must have Zubrod performance status 0-1 documented within 28 days prior
   to sub-study registration

   - Participants of reproductive potential must have a negative serum pregnancy test
   within 28 days prior to sub-study registration

   - Participants must agree to have blood specimens submitted for circulating tumor DNA
   (ctDNA)

   - Participants must be offered the opportunity to participate in specimen banking and in
   correlative studies for collection and future use of specimens. With participant
   consent, specimens must be collected and submitted via the Southwest Oncology Group
   (SWOG) Specimen Tracking System

   - Participants must be informed of the investigational nature of this study and must
   sign and give informed consent in accordance with institutional and federal guidelines

      - NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration
      process the treating institution's identity is provided in order to ensure that
      the current (within 365 days) date of institutional review board approval for
      this study has been entered in the system

   - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
   treating institution's identity is provided in order to ensure that the current
   (within 365 days) date of institutional review board approval for this study has been
   entered in the system

   - Participants with impaired decision-making capacity are eligible as long as their
   neurological or psychological condition does not preclude their safe participation in
   the study (e.g., tracking pill consumption and reporting adverse events to the
   investigator). For participants with impaired decision-making capabilities, legally
   authorized representatives may sign and give informed consent on behalf of study
   participants in accordance with applicable federal, local, and Central Institutional
   Review Board (CIRB) regulations

Exclusion Criteria:

   - Participants with spinal cord compression or brain metastases must not have residual
   neurological dysfunction, unless no further recovery is expected, and the participant
   has been stable on weaning doses of corticosteroids prior to sub-study registration

   - Participants must not have leptomeningeal disease unless: (1) asymptomatic and (2)
   only detected on radiographic imaging (i.e., not present in cytology from cerebral
   spinal fluid [CSF] if CSF sampled)

   - Participants must not have received any prior systemic therapy (systemic chemotherapy,
   immunotherapy or investigational drug) within 21 days prior to sub-study registration

   - Participants must not have received any radiation therapy within 14 days prior to
   sub-study registration, with the exception of stereotactic radiation to CNS metastases
   which must have been completed at least 7 days prior to sub-study registration

   - Participants must not have received prior AMG 510 or other KRAS^G12C specific
   inhibitor

   - Participants must not be planning to receive any concurrent chemotherapy,
   immunotherapy, biologic or hormonal therapy for cancer treatment while receiving
   treatment on this study

   - Participants must not have had a major surgery within 14 days prior to sub-study
   registration. Participant must have fully recovered from the effects of prior surgery
   in the opinion of the treating investigator

   - Participants must not have any grade III/IV cardiac disease as defined by the New York
   Heart Association criteria (i.e., participants with cardiac disease resulting in
   marked limitation of physical activity or resulting in inability to carry on any
   physical activity without discomfort), unstable angina pectoris, and myocardial
   infarction within 6 months, or serious uncontrolled cardiac arrhythmia

   - Participants must not have a prior or concurrent malignancy whose natural history or
   treatment has the potential to interfere with the safety or efficacy assessment of the
   investigational regimen

   - Participants must not have gastrointestinal disorders that may impact drug absorption

   - Participants must not have received strong inducers of CYP3A4 (including herbal
   supplements such as St. John's wort) within 14 days prior to sub-study registration
   and must not be planning to use strong inducers of CYP3A4 throughout protocol
   treatment

   - Participants must not have received CYP3A4 sensitive substrates (with a narrow
   therapeutic window) within 14 days prior to sub-study registration and must not be
   planning to use CYP3A4 sensitive substrates (with a narrow therapeutic window)
   throughout protocol treatment

   - Participants must not be pregnant or nursing. Participants with uteri must have agreed
   to use an effective contraceptive method for at least one month after the last dose of
   AMG 510. Participants with sperm must have agreed to use an effective contraceptive
   method for at least 3 months after the last dose of AMG 510. Participants are
   considered to be of "reproductive potential" if they have had menses at any time in
   the preceding 12 consecutive months and no prior oophorectomy and/or hysterectomy. In
   addition to routine contraceptive methods, "effective contraception" for participants
   with uteri also includes heterosexual celibacy and surgery intended to prevent
   pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
   bilateral oophorectomy or bilateral tubal ligation. Acceptable methods of birth
   control for participants with sperm include sexual abstinence (refraining from
   heterosexual intercourse); vasectomy with testing showing there is no sperm in the
   semen; bilateral tubal ligation or occlusion in the partner; or a condom (the female
   partner should also consider a form of birth control). However, if at any point a
   previously celibate participant chooses to become heterosexually active during the
   time period for use of contraceptive measures outlined in the protocol, he/she is
   responsible for beginning contraceptive measures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Hwang
650-723-0437
Recruiting

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