A Phase Ib Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

Study Identifier:
FURMO-002
CT.gov Identifier:
NCT05364073
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2023-508349-42-00
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To evaluate furmonertinib in patients with EGFR mutant non-small cell lung cancer

To evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations, including Exon 20 insertion mutations.

To evaluate the efficacy and safety of vometinib in the treatment of advanced NSCLC with EGFR or HER2 mutations.

To evaluate a TKI, firmonertinib, specifically in NSCLC patients with EGFR PACC mutations.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Gene Mutations
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Stage 1 Dose Escalation and Backfill
    • Read More
  • Drug: Experimental: Stage 2 Expansion Cohort 1
  • Drug: Experimental: Stage 2 Expansion Cohort 2
  • Drug: Experimental: Stage 2 Expansion Cohort 3
  • Drug: Experimental: Stage 2 Expansion Cohort 4
  • Drug: Previously treated NSCLC Patients with EGFR Activating Mutations
  • Drug: Intervention:
  • Drug: Common name in Chinese: Furmonertinib Mesilate Tablets
  • Drug: Sec filing 2024
  • Drug: Cohort Two is designed to enroll 20 patients with locally advanced or metastatic HER2 exon 20 insertion positive NSCLC, a mutation and patient population that is distinct from the exon 20 mutation and patient population. Patients in Cohort Two will have previously received systemic treatment and are to receive 240 mg furmonertinib once daily.
  • Drug: Cohort Three is designed to enroll 20 patients with locally advanced or metastatic NSCLC with an EGFR-activating mutation other than exon 20 insertion or PACC mutations who have previously received systemic treatment. Patients with classical EGFRm must have received prior osimertinib therapy. Participants in Cohort Three are to receive 240 mg furmonertinib once daily.
  • Drug: Cohort Four is designed to enroll 60 patients with locally advanced or metastatic NSCLC with EGFR PACC mutations who are TKI-treatment naive. Patients in Cohort Four are randomized into two groups, one group of up to 30 patients to receive 160 mg furmonertinib once-daily and the other group of up to 30 patients administered 240 mg furmonertinib once-daily.
  • Drug: WCLC 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
    • Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
    • Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
    • For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.
    • Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3 and 4:
    • -Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.
    • Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:
    • - Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
    • Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria
    • Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
    • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
    • Stage 2 Cohort 2 Previously treated, Locally Advanced or Metastatic NSCLC Patients with HER2 Exon 20 Insertion Mutations Inclusion Criteria
    • Documented validated results from local testing of either tumor tissue or blood confirming the presence of HER2 Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.
    • The patient must have experienced disease progression or have intolerance to treatment with platinum-based chemotherapy.
    • In regions in which fam-trastuzumab deruxtecan-nxki is approved and available for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 exon 20 mutations, the patient must have received or be considered not appropriate to receive fam-trastuzumab deruxtecan-nxki.
    • Stage 2 Cohort 3 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Activating Mutations Mutations, who are not eligible for Cohorts 1 and 4 Inclusion Criteria
    • Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR activating mutation, performed at a CLIA- or equivalently certified laboratory.
    • The patient must have experienced disease progression or have intolerance to treatment with the standard of care EGFR TKI.
    • Patients with CNS metastases may be eligible if meeting additional protocol specified criteria.
    • Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations excluding EGFR Exon 20 insertions Inclusion Criteria
    • Previously untreated in the locally advanced or metastatic setting or have progressed after at least 1 available standard therapy, or for whom standard therapy has proven to be ineffective, intolerable, or considered inappropriate
    • Documented validated results from local testing of either tumor tissue or blood confirming the presence of an EGFR Uncommon mutation, performed at a CLIA- or equivalently certified laboratory a. Representative mutations include, but are not limited to, G719X, S768I, E709X, G779F, L747X, V774M, E709_T710delinsD, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, T854X, T751_I759delins
    • 1 Sign the informed consent form.
    • 2 Age ≥ 18 years old when signing the informed consent form.
    • 3 Able to comply with the study protocol at the investigator's discretion.
    • 4 Have measurable lesions as defined by RECIST v1.1. Note: During the screening period, measurable target lesions (TL) can neither receive local treatment such as radiotherapy, nor biopsy; if there is only one measurable TL, the TL is allowed to be biopsied, but the baseline imaging examination of the lesion should be at Biopsies were performed at least 14 days later.
    • 5 Eastern Cooperative Oncology Group (ECOG) performance status score was 0 or 1.
    • 6 Expected survival time ≥ 12 weeks.
    • 7 Within 14 days before starting study treatment, have sufficient hematology and organ function, defined as follows: (1) absolute neutrophil count ≥ 1500/μL (2) hemoglobin ≥ 9 g/dL (3) platelet count ≥ 100,000/μL (4) Total bilirubin ≤ 1.5 × upper limit of normal (ULN), or, in patients with Gilbert syndrome (unconjugated hyperbilirubinemia) ≤ 3 × ULN (5) Aspartate aminotransferase ( AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN, with the following exceptions: AST and/or ALT ≤ 5.0 × ULN in patients with documented liver metastases Creatinine clearance ≥ 30 mL/ min: (140 — age) × body weight (kg) × (0.85 if female) 72 × serum creatinine (mg/dL) International Normalized Ratio (INR) ≤1.5 × ULN and activated partial prothrombin time (aPTT) ≤1.5 × ULN Note: This formula applies only to patients not receiving anticoagulant therapy. Patients receiving anticoagulant therapy should receive anticoagulant therapy at a stable dose for at least 1 week before day 1 of cycle 1.
    • 8 For women of childbearing potential (WOCBP): Agree to abstinence (avoid heterosexual intercourse) or use contraceptive measures, and agree not to donate eggs; the definition is as follows: (1) Menarche has passed but menopause has not yet occurred, and the continuous amenorrhea due to menopause is not More than 12 months (no cause other than menopause) and no permanent infertility due to sterilization surgery (removal of ovaries, fallopian tubes, and/or uterus) or other causes as determined by the investigator (such as mesonephric agenesis) women are considered fertile. The definition of fertility may be adjusted according to local guidelines or regulations. (2) WOCBP must maintain abstinence during treatment and for at least 60 days after the last dose of vometinib, or use a barrier method (such as a condom) plus another contraceptive method (the combination of the two makes the annual failure rate < 1%) . WOCBPs must avoid egg donation during treatment and for 6 months after the last dose of vometinib. (3) Examples of contraceptive methods with annual failure rates < 1% include: bilateral tubal ligation, male sterilization, ovulation-inhibiting hormonal oral contraceptives, hormone-releasing IUDs, and copper-containing IUDs. Note: The reliability of abstinence was assessed with respect to the duration of the clinical trial and the patient's preferred routine. Periodic abstinence (eg, calendar, ovulation, symptomatic body temperature, or postovulation) and withdrawal methods are inappropriate methods of contraception. Locally approved appropriate contraceptive methods and information on the reliability of abstinence will be described in the local informed consent form if required by local guidelines or regulations.
    • 9 For men who have not undergone sterilization: agree to abstinence (avoid heterosexual intercourse) or use contraceptive measures, and agree not to donate sperm, defined as follows: (1) During treatment and at least 60 days after the last dose of vometinib, men with fertile Abstinence or condom use with non-pregnant female partners of capacity and an additional method of contraception with an annual failure rate of < 1%. (2) Sperm donation must be avoided during treatment and for at least 60 days after the last dose of vometinib. (3) During the treatment period and at least 60 days after the last dose of the study drug, men must abstain from sex or use condoms when they are with their pregnant female partners to avoid embryo exposure. Note: The reliability of abstinence was assessed with respect to the duration of the clinical trial and the patient's preferred routine. Periodic abstinence (eg, calendar, ovulation, symptomatic body temperature, or postovulation) and withdrawal methods are inappropriate methods of contraception. Locally approved appropriate contraceptive methods and information on the reliability of abstinence will be described in the local informed consent form if required by local guidelines or regulations.
    • 10 Locally advanced or metastatic NSCLC ineligible for curative surgery or radiotherapy based on histological or cytological records
    • 11 Agree to provide tumor tissue specimens on file (formalin-fixed, paraffin-embedded [FFPE] tissue blocks [preferred] or at least 15 unstained serial sections from FFPE tumor specimens). Specimens must be provided during screening or no later than 30 days prior to Cycle 1 Day 1 and must be accompanied by a pathology report. (1) Specimens should preferably be derived from the most recent collection of available tumor tissue, and as far as possible from the metastatic site of the disease. See the laboratory manual for instructions.
    • 12 If the patient carries an EGFR mutation that is sensitive to osimertinib and is in a region where osimertinib has been approved (including the United States [US]), the patient must have received osimertinib before enrollment in the study.
    • 13 There is no known acquired resistance to osimertinib (eg, C797S or cMet amp). Other changes should be discussed with the Medical Monitor.
    • 14 Phase 1 Dose Escalation and Backfill Cohort and Phase 2 Cohorts 1, 2 and 3 Inclusion Criteria: Disease progressed after at least 1 available standard therapy, or standard therapy proved ineffective, intolerable or deemed inappropriate, or a clinical trial of an investigational drug is the accepted standard of care For patients who have progressed on at least 1 available standard therapy, if other approved standard therapy options are available, the investigator must advise of these additional approved treatment options and discuss the risks and benefits of these treatments before obtaining informed consent to participate in this study. These discussions must be entered in the patient record.
    • 15 Phase 1 Dose Escalation and Backfill Cohorts and Phase 2 Cohorts 1, 2 and 3 Inclusion Criteria: Documented radiographic disease progression before first dose of study drug (voumetinib) during or after last systemic anticancer therapy.
    • 16 Phase 1 dose escalation and backfill cohort inclusion criteria: Confirmed presence of EGFR exon 20 insertion mutation (i.e., addition of 1 or more amino acids), HER2 exon 20 insertion mutation by local laboratory testing in tumor tissue or blood or EGFR activating mutations (including EGFR PACC mutations, exon 19 and exon 21 mutations, such as exon 19 deletions, L858R and L861Q, with or without EGFR T790M mutation)? Must use a validated Next Generation Sequencing (NGS) or Polymerase Chain Reaction (PCR) assay from a Clinical Laboratory Improvement Amendments (CLIA) accredited laboratory or equivalent.
    • 17 Phase 2, cohort 1 (treatment-experienced locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation) inclusion criteria: Confirmed presence of EGFR exon 20 insertion mutation by local laboratory testing of tumor tissue or blood (ie, adding 1 or more amino acids) Must use a validated NGS or PCR assay from a CLIA-certified or equivalent laboratory.
    • 18 Phase 2, Cohort 1 (treatment-experienced patients with locally advanced or metastatic NSCLC with an EGFR exon 20 insertion mutation) Inclusion criteria: Patients must have experienced disease progression (during or after treatment) or be intolerant to platinum-based chemotherapy by. Note: Previous treatment with any EGFR-TKI or drugs targeting EGFR exon 20 insertion mutations is allowed. At least 10 patients who have been previously treated with amivantamab will be enrolled.
    • 19 Phase 2, cohort 2 (treatment-experienced locally advanced or metastatic NSCLC patients with HER2 exon 20 insertion mutation) inclusion criteria: Confirmed presence of HER2 exon 20 insertion mutation by local laboratory testing of tumor tissue or blood ? A validated PCR or NGS assay must be used and the laboratory needs to be CLIA certified or equivalent.
    • 20 Phase 2, Cohort 2 (treatment-experienced patients with locally advanced or metastatic NSCLC harboring a HER2 exon 20 insertion mutation) Inclusion criteria: Patients must have experienced disease progression (during or after treatment) or be intolerant to platinum-based chemotherapy by
    • twenty one Phase 2, cohort 2 (treatment-experienced locally advanced or metastatic NSCLC patients carrying HER2 exon 20 insertion mutations) inclusion criteria: in fam-trastuzumab deruxtecan-nxki (ENHERTU trastuzumab recombinant lyophilized powder injection, Desi trastuzumab) is approved and available for the treatment of adult patients with unresectable or metastatic NSCLC harboring HER2 exon 20 activating mutations, patients must have received desi trastuzumab or be deemed unsuitable Suitable for treatment with Dexi Trastuzumab. Note: Previous treatment with drugs targeting HER2 exon 20 insertion mutations is allowed. At least 10 HER2-TKI-naïve patients will be enrolled.
    • twenty two Phase 2, cohort 3 (treatment-experienced patients with locally advanced or metastatic NSCLC with EGFR activating mutations [except exon 20 insertion mutations and PACC mutations]) inclusion criteria were confirmed by local laboratory testing of tumor tissue or blood for the presence of EGFR activating mutations (including exon 19 and exon 21 mutations, such as exon 19 deletions, L858R and L861Q, with or without EGFR T790M mutation) must be detected using validated NGS or PCR The laboratory needs to be a CLIA-certified or equivalent laboratory.
    • twenty three Phase 2, Cohort 3 (treated patients with locally advanced or metastatic NSCLC with EGFR activating mutations [except exon 20 insertions and PACC mutations]) inclusion criteria Patients with CNS metastases are eligible, provided they meet All of the following criteria: (1) measurable lesions outside the CNS (2) untreated brain metastases, ≤ 2.0 cm in diameter and currently not requiring local therapy (3) allowed continuous use of a total daily dose of dexamethasone ≤ 2 mg (or Equivalent drugs) systemic corticosteroids to control symptoms of brain metastases (4) Seizures are well controlled without the use of enzyme-inducing antiepileptic drugs (carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, felbamate ) (5) For patients who have been previously treated for brain metastases: - Stable or progressing after previous local CNS therapy - Accept for new lesions shown on enhanced brain MRI performed during screening if all of the following criteria are met Patients with CNS local therapy may be eligible for enrollment: WBRT to first dose of study treatment ≥ 21 days, SRS to first dose of study treatment ≥ 7 days, or surgical resection to first dose of study treatment ≥ 28 days Days - No topical therapy currently required - Patients who receive topical therapy for lesions detected by contrast-enhanced brain MRI at Screening may still be eligible for study based on the above criteria.
    • twenty four Phase 2, Cohort 4 (Treatment-naïve or previously treated EGFR-TKI-naïve locally advanced or metastatic NSCLC patients with EGFR PACC mutations) Inclusion criteria Not previously treated in locally advanced or metastatic setting, OR Progression after at least 1 available standard therapy, or standard therapy has been proven ineffective, intolerable, or deemed inappropriate
    • 25 Phase 2, cohort 4 (treatment-naïve or previously treated EGFR-TKI-naive locally advanced or metastatic NSCLC patients with EGFR PACC mutations) Inclusion criteria Detect and confirm the presence of EGFR PACC mutations Representative mutations include but are not limited to G719X, S768I, E709A/V, G724S, G779F, K757X, L747X, N771G, R776X, V769X, V774M, E709_T710del insD and I740_K745dup.
    • Key eligibility criteria include documented EGFR PACC mutation, measurable disease per RECIST 1.1, and no prior EGFR TKI.
    Exclusion criteria
    • Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
    • Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
    • Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
    • AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.
    • Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naive, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria
    • Prior treatment with any EGFR TKIs
    • Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.
    • 1Inability or unwillingness to swallow pills.
    • 2Failure to comply with study or follow-up procedures.
    • 3Malabsorption syndrome or other diseases that affect intestinal absorption.
    • 4With pleural effusion, pericardial effusion, or peritoneal effusion requiring repeated biweekly or more frequent drainage If patient has recovered adequately from surgery, is hemodynamically stable, and has improved symptoms, indwelling thoracic cavity is permitted after discussion with sponsor or abdominal catheter.
    • 5Serious acute or chronic infections, including: Uncontrolled acute infection within 2 weeks prior to the first dose of voumetinib, active infection requiring systemic therapy or systemic antibiotic therapy. Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome. HIV status was unknown and patients who did not consent to HIV testing were not eligible. Patients with active chronic hepatitis B or active hepatitis C infection, including hepatitis B surface antigen (HbsAg) positive, HBsAg negative and hepatitis B core antibody (HBcAb) positive, or hepatitis C virus (HCV) antibody at screening In positive patients, quantitative detection of hepatitis B virus (HBV) DNA (e.g., ≤ 2500 copies/mL or 500 IU/mL) and HCV RNA (e.g., ≤ lower limit of detection) can conclusively exclude activity requiring treatment Patients who were previously infected with hepatitis B or C cannot be enrolled. Note: Hepatitis B virus carriers who have stable hepatitis B virus infection after drug treatment (for example, quantitative detection of hepatitis B virus DNA, DNA ≤ 2500 copies/mL or 500 IU/mL), or those who are cured of hepatitis C can be enrolled. If the lower limit of detection of HBV DNA in the center is higher than 2500 cps/mL or 500 IU/mL, patients whose HBV DNA quantitative test results are lower than the lower limit of detection are considered eligible.
    • 6In outbreak or epidemic situations, active infection screening should be considered according to local or institutional guidelines or guidelines from applicable professional societies (eg, American Society of Clinical Oncology [ASCO] or European Society for Medical Oncology [ESMO]).
    • 7Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis; or active ILD.
    • 8History of clinically significant cardiovascular dysfunction or active cardiovascular dysfunction, including: Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose of voumetinib Have a history of myocardial infarction within 6 months before the drug Have New York Heart Association (NYHA) class III or IV heart disease or congestive heart failure that requires drug treatment Have a history of uncontrolled arrhythmia that requires drug treatment, ventricular arrhythmia or active ventricular arrhythmia symptomatic coronary artery disease, or unstable angina
    • 9The average resting corrected QT interval (QTc) of three electrocardiograms (ECGs) >470 ms (QT interval corrected by Fridericia's formula [QTcF] obtained using the screening office electrocardiograph).
    • 10Presence of clinically significant QT prolongation, or other arrhythmias or clinical conditions that, in the opinion of the investigator, may increase the risk of QT prolongation (eg, complete left bundle branch block, grade III atrioventricular block, grade II Heart block, PR interval > 250 ms, congenital long QT syndrome, family history of long QT syndrome, sudden unexplained death in immediate family under age 40, severe hypokalemia, heart failure), or current Use of drugs that prolong the QT interval.
    • 11Symptomatic hypercalcemia requiring continuous treatment with bisphosphonates or denosumab
    • 12Severe trauma or major surgery within 4 weeks before Day 1 of Cycle 1
    • 13Have chronic diarrhea, short bowel syndrome or have undergone major upper gastrointestinal (GI) surgery (including gastrectomy), history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or any active bowel inflammation (including patients with diverticulitis).
    • 14Presence of any other medical condition, such as pulmonary dysfunction, metabolic disorder, abnormal physical examination, clinical laboratory abnormalities, and it cannot be ruled out that these diseases may contraindicate the use of vometinib, may affect the interpretation of results, or put the patient at high risk of treatment complications Moderate (eg, uncontrolled hypertension, active bleeding).
    • 15Received chemotherapy, targeted therapy, biologic therapy, or other anticancer therapy for investigational purposes within 3 weeks or 5 half-lives (whichever is shorter) prior to the start of voumetinib treatment
    • 16Cancer treated with radiotherapy (except for palliative radiotherapy for bone metastases and for aforementioned CNS metastases) within 4 weeks prior to the start of vumetinib therapy.
    • 17Received palliative radiotherapy for bone metastases within 2 weeks prior to the start of fomertinib therapy.
    • 18AEs due to prior anticancer therapy that did not resolve to grade ≤ 1 (except alopecia), or peripheral neuropathy ≤ grade 2.
    • 19History of other malignancies within 3 years prior to screening, except for those with minimal risk of metastasis or death and/or with expected curative outcomes after treatment (e.g., adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer).
    • 20Pregnant, breast-feeding, or planning to become pregnant during the study period or within 60 days of the last dose of vometinib. For WOCBP (including women with tubal ligation), a negative serum pregnancy test result within 14 days before the start of study drug was required.
    • twenty oneKnown or suspected hypersensitivity to vometinib or other components of its preparations.
    • twenty twoUse of a strong CYP3A4 inhibitor within 7 days or a strong CYP3A4 inducer within 21 days of the first dose of the test drug.
    • twenty threeHerbal medicines (such as traditional Chinese medicine or traditional Chinese medicine preparations for the treatment of cancer, or traditional Chinese medicine or traditional Chinese medicine preparations with auxiliary anticancer effects) were used within 2 weeks before the first administration of Fumetinib or expected to be used during the study.
    • twenty fourPhase 2, cohort 3 (treatment-experienced patients with locally advanced or metastatic NSCLC with EGFR activating mutations [except exon 20 insertions and PACC mutations]) Exclusion criteria EGFR 20 confirmed by local testing (tumor tissue or blood) NSCLC patients with exon insertion mutations
    • 25Phase 2, cohort 3 (treated patients with locally advanced or metastatic NSCLC with EGFR activating mutations [except exon 20 insertions and PACC mutations]) Exclusion criteria EGFR PACC confirmed by local testing (tumor tissue or blood) Mutated NSCLC patients
    • 26Phase 2, Cohort 4 (Treatment-naive or previously treated EGFR-TKI-naive locally advanced or metastatic NSCLC patients with EGFR PACC mutations) Exclusion Criteria: Previously received any EGFR-TKI therapy
    • 27Phase 2, cohort 4 (treatment-naive or previously treated EGFR-TKI-naive locally advanced or metastatic NSCLC patients with EGFR PACC mutations) Exclusion Criteria Progression during or within 12 months of completion of the above treatment

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Ramon Yarza
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Gene Mutations