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    Summary
    EudraCT Number:2021-001696-16
    Sponsor's Protocol Code Number:SOLUCOM
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-08-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2021-001696-16
    A.3Full title of the trial
    Sotorasib in advanced KRASG12C-mutated non-small cell lung cancer patients with comorbidities
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sotorasib in patients with non-small cell lung cancer with genetic changes with comorbidities
    A.3.2Name or abbreviated title of the trial where available
    SOLUCOM
    A.4.1Sponsor's protocol code numberSOLUCOM
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVestre Viken Health Trust
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVestre Viken Health Trust
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVestre Viken Health Trust
    B.5.2Functional name of contact pointOdd Terje Brustugun
    B.5.3 Address:
    B.5.3.1Street AddressDronninggata 28
    B.5.3.2Town/ cityDrammen
    B.5.3.3Post code3004
    B.5.3.4CountryNorway
    B.5.4Telephone number004799723094
    B.5.6E-mailotr@vestreviken.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namesotorasib
    D.3.2Product code AMG510
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSotorasib
    D.3.9.1CAS number 2252403-56-6
    D.3.9.2Current sponsor codeAMG510
    D.3.9.3Other descriptive nameAMG510
    D.3.9.4EV Substance CodeSUB197397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number960
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced KRASG12C-mutated non-small cell lung cancer patients with comorbidities
    E.1.1.1Medical condition in easily understood language
    Lung cancer with specific gene alteration/mutation in the KRAS gene
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025044
    E.1.2Term Lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.1
    E.1.2Level LLT
    E.1.2Classification code 10069759
    E.1.2Term KRAS mutation
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10075674
    E.1.2Term KRAS codon 12 and 13 mutation
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of sotorasib in reducing tumour size in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-)immunotherapy)
    E.2.2Secondary objectives of the trial
    To further assess efficacy parameters
    To evaluate patient-reported outcome during treatment assessed by the following questionnaires:
    - European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 13 (EORTC QLQ-LC13)
    - European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30)
    - EuroQol 5-dimensional descriptive system (EQ-5D-5L)
    To assess the safety profile of sotorasib

    To investigate factors involved in response, resistance and toxicity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated, written informed consent.
    2. Age > 18 years.
    3. Histologically or cytologically documented NSCLC stage III/IV not amenable for curative treatment. Patients that have received systemic adjuvant therapy for non-metastatic disease in the past will need a new biopsy before inclusion if no biopsy acquired after adjuvant therapy is available.
    4. Documented KRASG12C mutation, based on tissue analysis on either archived tissue or new biopsy before inclusion, and verified locally by a validated method.
    5. Subjects will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for NSCLC stage III/IV not amenable for curative treatment. Prior treatment must include checkpoint inhibitor for advanced or metastatic disease, either given alone or in combination with chemotherapy unless the subject has a medical contraindication to one of the required therapies.
    a. Adjuvant therapy will count as a line of therapy if the subject progressed on or within 6 months of adjuvant therapy administration.
    b. Disease progression on or within 6 months of end of prior curatively intended multimodal therapy will count as a line of therapy.
    6. ECOG status 0-2 and a minimum life expectancy of 12 weeks. At least 60 patients should be in ECOG 2. When 40 patients in ECOG 0-1 are included, the inclusion criteria will change to only ECOG 2.
    7. At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1. Brain metastases are not regarded measurable.
    8. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
    - Post-menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
    - Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution
    - Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
    9. Male subjects must be willing to use barrier contraception.
    E.4Principal exclusion criteria
    1. Previously identified driver mutation (according to local standard of care or guidelines) other than KRASG12C for which an approved therapy is available(including EGFR, ALK, etc).
    2. Subjects with symptomatic CNS metastases or leptomeningeal disease who are neurologically unstable or have required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to study day 1.
    3. Major surgery within 4 weeks of inclusion
    4. RT within 2 weeks of inclusion
    5. Previous treatment with sotorasib or other KRASG12C inhibitor
    6. Use of warfarin. Other anticoagulation is allowed.
    7. Patients with significant comorbidities other than those mentioned below:
     Comorbidities of special interest(up to grade 2 according to ACE-27 scoring system), or toxicity CTCAE 2) are eligible(ACE-27 grade 3 or CTCAE grade 3 may be eligible after discussion with Sponsor). Patients may have more than one comorbidity as long as all are within the severity grades as mentioned. Comorbidities of special interest are the following:
    -Autoimmune diseases (rheumatoid, colitis, diabetes, skin,multiple sclerosis etc), including immunotherapy-induced morbidity (colitis, pneumonitis,endocrinopathies, hepatitis, nephritis etc). Immunotherapy-induced colitis or pneumonitis must be resolved to max CTCAE 2, and a max use of prednisolone 10 mg or equivalent is allowed.
    -Smoking-induced diseases (cardiovascular (coronary artery disease, apoplexia, thromboembolic events), COPD/emphysema etc)
    8. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable to participate in the trial or could jeopardise compliance with the protocol, or active infection including hepatitis B, hepatitis C and HIV. Screening for chronic conditions is not required.
    9. Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives 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 (including herbal supplements such as St. John’s wort) within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the PI.
    10. Previous malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, oesophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry.
    11. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication.
    12. Mean resting corrected QT interval (QTc) > 470 msec (females) or > 450 msec (males) using the screening clinic ECG machine derived QTc value.
    13. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
    -Absolute neutrophil count <1.5x109/L
    -Platelet count <100x109/L
    -Haemoglobin <9.0g/dL
    -Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
    -Aspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver metastases or > 5 times ULN in the presence of liver metastases
    -Total bilirubin >1.5 times ULN if no liver metastases or >3 times ULN in the presence of documented Gilbert’s Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
    -Serum creatinine >1.5 times ULN concurrent with creatinine clearance <50mL/min [measured or calculated by Cockcroft and Gault equation]—confirmation of creatinine clearance is only required when creatinine is >1.5 times ULN
    14. History of hypersensitivity of active or inactive excipients of sotorasib or drugs with a similar chemical structure/class to sotorasib.
    15. Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.
    16. Any unresolved toxicities from prior therapy greater than CTCAE grade 2, unless discussed with Sponsor.
    17. Women who are pregnant or breast-feeding, or have a positive pregnancy test prior to study entry
    18. Involvement in the planning and/or conduct of the study (investigator staff and/or staff at the study site).
    19. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) of sotorasib in the predefined patient groups (including ECOG PS2, specific comorbidities, including immune-related adverse events after (chemo-) immunotherapy)
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of trial
    E.5.2Secondary end point(s)
    - Progression Free Survival (PFS)
    - Duration of Response (DoR)
    Disease Control Rate (DCR)
    - Intracranial Disease Free Survival (iDFS)
    - Intracranial Time To Recurrence (iTTR)
    - Tumour shrinkage
    - Overall Survival (OS)
    - Time on treatment post progression
    Change from baseline over time to week 12 in disease related symptoms, physical functioning and global health status as measured by QLQ-C30 and QLQ-LC13
    Summary scores at each assessment and changes from baseline of visual analogue scale (VAS) scores as measured by EQ-5D-5L)
    To estimate the subject incidence of treatment-emergent adverse events, treatment-related adverse events, changes in vital signs, and clinical laboratory tests
    Molecular characterization (see below) of blood and tissue before commencement on sotorasib, at response and at progression on sotorasib
    - NGS (deep targeted sequencing of tumour tissue), STK11/LKB1, KEAP1, p53 etc
    - Molecular analyses (incl NGS, e.g. Avenio) of blood samples (ctDNA)
    - Array-based microRNA, methylation, mRNA expression
    - Protein analyses based on IHC, including immune-markers as PD-L1, IL-10, STING, TGFbeta etc
    - Exploratory analyses to be determined
    Details on concomitant medication, specifically proton pump inhibitors, correlated to response rates and toxicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    at predefined evaluation points (every 8 week) and end of trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    QoL and translational research
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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