A Phase I Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene

Study Identifier:
C5421001
CT.gov Identifier:
NCT06447662
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
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Study Summary

The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.

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.
  • Solid Tumor
  • Pancreas
  • Bowel (Colorectal)
  • Non-Small Cell Lung Cancer
    • 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: Part 1
    • Read More
  • Drug: Drug: PF-07934040
  • Drug: Experimental: Part 2a Cohort A1
  • Drug: Experimental: Part 2a Cohort B1
  • Drug: Experimental: Part 2a Cohort C1
  • Drug: Experimental: Part 2b Cohort A2
  • Drug: Prescribed dose and frequency in 28-day cycles
  • Drug: Combination Product: Gemcitabine
  • Drug: Combination Product: Nab-paclitaxel
  • Drug: Experimental: Part 2b Cohort B2
  • Drug: Combination Product: Cetuximab
  • Drug: Experimental: Part 2b Cohort B3
  • Drug: Combination Product: Fluorouracil
  • Drug: cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
  • Drug: Combination Product: Oxaliplatin
  • Drug: platinum based compound (alkylating agent)
  • Drug: Combination Product: Leucovorin
  • Drug: Folic Acid Analog
  • Drug: Combination Product: Bevacizumab
  • Drug: Experimental: Part 2b Cohort C2
  • Drug: Prescribed dose and frequency in 21-day cycles
  • Drug: Combination Product: Pembrolizumab
  • Drug: Experimental: Part 2b Cohort C3
  • Drug: Combination Product: pemetrexed
  • Drug: Antimetabolite
  • Drug: Combination Product: Cisplatin
  • Drug: Platinum-based antineoplastic (alkylating agent)
  • Drug: Combination Product: Paclitaxel
  • Drug: Taxane
  • Drug: Combination Product: Carboplatin
  • Drug: platinum containing compound (alkylating agent)
  • Drug: All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles.
  • Drug: Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle.
  • Drug: Participants can continue to take the study medication (PF-07329640) and the combination anti-cancer therapy until their cancer is no longer responding.
  • Drug: The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.
  • Drug: Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.
  • Drug: Serial numbernameusage
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • - Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or
    • relapsed/refractory solid tumor.
    • ECOG PS 0 or 1
    • - Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been
    • previously irradiated.
    • - Documentation of mutated KRAS gene
    • 1. PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
    • 2. NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. If
    • driver mutation, must have failed precision medicine therapy [eg, inhibitors of
    • epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros
    • oncogene 1 (ROS1), and others].
    • - Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for
    • which no additional, effective therapy is available.
    • 1. PDAC (2-3L): Participants must have received and radiologically progressed on
    • prior lines of systemic therapy for metastatic pancreatic adenocarcinoma. If
    • participants received prior neoadjuvant or adjuvant chemotherapy and progressed
    • within 6 months of the last dose, then this should be considered as a prior line
    • of systemic therapy.
    • 2. NSCLC (2-3L): Participants must have received prior lines of anti-cancer
    • treatment and progressed on at least a platinum-containing chemotherapy regimen
    • and checkpoint inhibitor therapy; for participants with EGFR, ALK, or other
    • genomic tumor alterations, participants must have progressed on approved therapy
    • for these alterations.
    • 3. CRC (2-3L): Participants must have had one or two prior systemic treatment
    • regimens for mCRC. For either one or two prior treatments, these regimens must
    • have included a fluoropyrimidine, oxaliplatin, or irinotecan; for one prior
    • treatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional;
    • 4. Other tumors: Participants, in the judgment of the investigator, must have
    • progressed or become intolerant to all available standard therapies, or have
    • refused such therapy.
    • - Part 2b:
    • 1. PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy for
    • metastatic disease. Participant could have received neoadjuvant therapy, adjuvant
    • therapy, or adjuvant chemo-radiotherapy, as long as relapse did not occur within
    • 6 months of completing these forms of adjuvant treatment. If so, the relapse
    • within 6 months would be considered a line of therapy; the participant would be
    • considered 2L, and not 1L.
    • 2. CRC (2-3L) Cohort B2: Participants must have had one or two prior systemic
    • treatment regimens for mCRC. For either one or two prior treatments, these
    • regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; for one
    • prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional.
    • 3. CRC (1L) Cohort B3: Participants must not have had prior chemotherapy for
    • advanced or metastatic disease. Participant could have received adjuvant
    • chemotherapy or adjuvant chemo-radiotherapy, as long as relapse did not occur
    • within 6 months of complete of adjuvant therapy. If so, the relapse within 6
    • months would be considered a line of therapy; the participant would be considered
    • 2L, and not 1L.
    • 4. NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have
    • received prior systemic treatment setting.
    • 5. NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior
    • systemic treatment setting.
    • 1 ≥ 18 years of age at screening (or minimum age of consent as determined by local regulations). See Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) research participants.
    • 2 Advanced, unresectable, metastatic disease as diagnosed by histology or cytology. Note for PDAC: Only participants with pancreatic adenocarcinoma histology are allowed to be enrolled. For PDAC, if localized disease is present, participants must also have metastatic disease.
    • 3 Documented presence of a mutated KRAS gene. KRAS mutations in any variant in tumor tissue or blood (e.g., ctDNA) other than G12C on prior treatment. KRAS mutations confirmed prior to screening by local laboratory assay results obtained in a CLIA or similarly certified laboratory based on PCR or NGS. If study participants have previously been treated with a KRAS G12C inhibitor, KRAS mutation status must be other than G12C. This mutation status should be determined after study participants have progressed on their last treatment (if this is not possible, this needs to be discussed with the sponsor). Note for NSCLC: If a driver mutation is present, it must be a failure of precision medicine therapy (e.g., inhibitors of EGFR, ALK, ROS1, others).
    • 4 Part 1 and Part 2a: Study participants must have had tumor progression on standard therapy and no other effective treatment available. a. PDAC (2-3L): Study participants must have received prior systemic therapy for metastatic pancreatic adenocarcinoma and had radiologic progression. If study participants had received prior adjuvant chemotherapy and had progression within 6 months of the last dose, that therapy was considered to be the first line of prior systemic therapy. b. NSCLC (2-3L): Study participants must have received prior systemic therapy and had progression on at least one platinum-containing chemotherapy regimen and a checkpoint inhibitor. For study participants with EGFR, ALK, or other tumor genomic alterations, study participants must have had tumor progression on an approved therapy targeting these alterations. c. CRC (2-3L): Study participants must have received one or two prior systemic treatment regimens for mCRC. For one or two prior therapies, one of which must have included a fluoropyrimidine, irinotecan, and/or oxaliplatin, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional. d. Other tumors: Study participants must have had tumor progression or intolerance to all available standard therapies, or have refused such treatment, in the investigator's judgment.
    • 5 Part 2b: a. PDAC (1L) Cohort A2: Study participants must not have received prior chemotherapy for metastatic disease. Study participants may have received prior neoadjuvant, adjuvant, or adjuvant chemoradiation therapy, provided they have not relapsed within 6 months of completing these forms of adjuvant therapy. If undergoing such therapy, relapse within 6 months will be considered a line of treatment; study participants will be considered 2L, not 1L. b. CRC (2-3L) Cohort B2: Study participants must have received one or two prior systemic treatment regimens for mCRC. For one or both prior treatments, one of the regimens must have included a fluoropyrimidine, irinotecan, and/or oxaliplatin, and exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional. c. CRC (1L) Cohort B3: Study participants must not have received prior chemotherapy for metastatic disease. Study participants may have received prior neoadjuvant, adjuvant, or adjuvant chemoradiation therapy, provided they have not relapsed within 6 months of completing these forms of adjuvant therapy. If such treatment has been experienced, relapse within 6 months will be considered a line of treatment; study participants will be considered 2L, not 1L. Considerations for CRC: Study participants with known MSI-H or dMMR must have received prior treatment with a PD-1 inhibitor (e.g., pembrolizumab). Study participants with metastatic CRC with known BRAF V600E mutations must have received prior treatment with a BRAF inhibitor (e.g., encorafinib). d. NSCLC (1L) Cohort C2: Study participants must have a TPS ≥ 50% and must not have received prior systemic therapy for metastatic disease. e. NSCLC (1L) Cohort C3: Study participants may have any TPS (including TPS < 1%) and must not have received prior systemic therapy in the setting of metastatic disease. f. Additional Cohorts: Indications may be selected and defined based on emerging data from Part 1. These study participants will receive novel combination therapy, including study drug at up to 2 dose levels in the novel regimen being investigated.
    • 6 Any acute effects of previous treatment resolved to baseline severity or CTCAE ≤ Grade 1 (except for AEs that were judged by the investigator not to pose a safety risk).
    • 7 The presence of at least 1 measurable lesion that has not been previously treated with radiotherapy as defined by RECIST version 1.1.
    • 8 Availability of pre-treatment tumor tissue (recently obtained [within 12 months prior to Day 1] archived FFPE tumor tissue sample, or a fresh tumor biopsy sample obtained at Screening). If emerging data warrant a biopsy, the sponsor may mandate a biopsy at that time. Details of tissue collection are provided in the laboratory manual. a. Baseline/Pre-treatment Tumor Tissue: All study participants must have a recent archived FFPE tumor tissue sample, or a fresh tumor biopsy sample obtained at Screening. If a study participant has an archived sample older than 12 months and a pre-treatment fresh biopsy sample cannot be safely obtained, the investigator must contact the sponsor in advance to discuss their eligibility. Freshly obtained fresh biopsies should be limited to non-target lesions, if feasible. b. On-treatment Tumor Biopsy Samples: Freshly obtained fresh biopsies should be limited to non-target lesions, if feasible. If emerging data warrant a biopsy, the sponsor may mandate a biopsy at that time. In addition, paired biopsies will be required if mandatory biomarker cohorts are enrolling study participants during RDE monotherapy dose expansion (see Section 8.7).
    • 9 ECOG PS 0 or 1.
    • 10 Study participants with brain metastases must meet all of the following criteria: a. Completed the planned course of treatment or have brain metastases that are assessed by the investigator in consultation with the sponsor to be small, stable, and not growing; b. Have recovered from the acute effects of radiation therapy or neurosurgery prior to the first planned dose (Day 1); c. Have stopped corticosteroid therapy for these metastases for at least 4 weeks prior to Day 1; d. Have been receiving a stable dose of an anti-epileptic medication (if applicable) for at least 3 months. The anti-epileptic medication must meet any eligibility criteria for concomitant medications in Section 6.9. e. Have achieved neurological stability after the end of treatment as documented by neurological examination and MRI. f. Study participants with CNS metastases diagnosed during the screening period must also meet these criteria.
    Exclusion criteria
    • - Active or history of pneumonitis/ILD, pulmonary fibrosis requiring treatment with
    • systemic steroid therapy, including evidence to suggest pneumonitis/ILD on baseline
    • assessments including imaging.
    • - Diagnosis of immunodeficiency or an active autoimmune disease that require systemic
    • treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of
    • prednisone equivalent) or any other form of immunosuppressive therapy in the past 2
    • years.
    • - Sensory peripheral neuropathy ≥Grade 2
    • - Active or history of clinically significant gastrointestinal (GI) disease (including
    • but not limited to inflammatory GI disease [eg, ulcerative colitis, Crohn's disease,
    • inflammatory bowel disease], immune-mediated colitis, peptic ulcer disease, GI
    • bleeding, chronic diarrhea) and other conditions that are unresolved and/or may
    • increase the risk associated with study participation or study treatment
    • administration.
    • - Active bleeding disorder, including GI bleeding, as evidenced by hematemesis,
    • significant hemoptysis or melena in the past 6 months.
    • - Major surgery or completion of radiation therapy ≤4 weeks prior to
    • enrollment/randomization or radiation therapy that included >30% of the bone marrow.
    • - Known sensitivity or contraindication to any component of study intervention (PF
    • 07934040, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU,
    • pembrolizumab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s), cyclin-dependent
    • kinase (CDK) inhibitor(s), antibody drug conjugates (ADCs) or EGFR inhibitor(s)).
    • - Hematologic abnormalities.
    • - Renal impairment.
    • - Hepatic abnormalities.
    • 1Any medical or psychiatric condition that may increase the risk of study participation or (in the investigator's judgment) may make the study participant unsuitable for study participation, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormalities.
    • 2Non-infectious pulmonary inflammation or fibrosis: Active disease requiring systemic steroids (based on screening evaluation or chest imaging); or history of prior non-infectious pulmonary inflammation/ILD, including pulmonary fibrosis.
    • 3Study participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell invasive skin cancer or squamous cell carcinoma in situ (Bowen's disease). Study participants with a history of other treated cancers must be discussed and approved by the sponsor prior to study entry.
    • 4History of venous thrombotic events (< 12 weeks prior to starting study treatment). Deep vein thrombosis of the lower extremities or pulmonary embolism were excluded from the study unless the study participant was asymptomatic and on a stable dose of anticoagulants for at least 4 weeks prior to starting study treatment. Upper extremity catheter-related venous thrombosis was not an exclusion criterion. However, study participants had to be on anticoagulation therapy for at least 4 weeks prior to starting study treatment.
    • 5Diagnosed immunodeficiency or active autoimmune disease requiring long-term systemic steroid therapy (doses exceeding 10 mg/day prednisone equivalents) or any other form of immunosuppressive therapy within the past 2 years.
    • 6Part 2b only: ≥ Grade 2 peripheral sensory neuropathy
    • 7Current or past clinically significant gastrointestinal disease (including but not limited to inflammatory gastrointestinal disease, immune-mediated colitis, peptic ulcer disease, gastrointestinal bleeding, chronic diarrhea), and other conditions that have not been resolved and/or may increase the risks associated with participation in the study or administration of study treatment.
    • 8Active bleeding disorder within the past 6 months, including gastrointestinal bleeding (confirmed by hematemesis or melena) or massive hemoptysis.
    • 9Currently taking any prohibited concomitant medications, or being unwilling or unable to take required concomitant medications. See section 6.9.
    • 10Received systemic anticancer therapy within 4 weeks or 5 half-lives (6 weeks for mitomycin C or nitrosourea) (whichever is shorter) before the first planned dose. Previous targeted or endocrine therapy requires an interval of 2 weeks or 5 half-lives (whichever is shorter) before the first planned dose.
    • 11Major surgery or completed radiotherapy within ≤ 4 weeks before enrollment/randomization, or radiotherapy involving > 30% of the bone marrow.
    • 12History of grade ≥ 3 immune-mediated or related AEs (including elevated AST/ALT believed to be drug-related) and cytokine release syndrome that are believed to be related to previous immunomodulatory therapy (e.g., immune checkpoint inhibitors, co-stimulatory agents, etc.) and require immunosuppressive therapy. Study participants with a history of vitiligo or thyroid dysfunction who have stopped immunosuppressive therapy for at least 6 months are excluded, and this needs to be determined in consultation with the sponsor.
    • 13Known sensitivity to or contraindication to any component of the study treatment intervention.
    • 14Received an investigational drug (drug or vaccine) within 30 days (or as determined by local requirements) or 5 half-lives (whichever is longer) before the first dose of the investigational drug.
    • 15Renal impairment, defined as an estimated creatinine clearance of < 60 mL/min calculated by the Cockcroft-Gault method.
    • 16Hematologic abnormalities, defined as: a. ANC <1500/mm3 or 1.5 x 109/L b. Platelets <100,000/mm3 or 100 x 109/L c. Hemoglobin ≤ 9 g/dL. Transfusion support is permitted if completed 14 days prior to the start of study treatment and hemoglobin remains ≥ 9 g/dL at the start of study treatment.
    • 17Liver abnormalities, defined as: a. total serum bilirubin ≥ 1.5 x ULN, unless the study participant had documented Gilbert syndrome (≥ 2.0 x ULN); b. AST and ALT ≥ 2.5 x ULN (≥ 5.0 x ULN if tumor involved the liver); c. alkaline phosphatase ≥ 2.5 x ULN (≥ 5 x ULN if bone metastases were present).
    • 18Study participants with active, uncontrolled bacterial, fungal, or viral infections, including (but not limited to) known history of HBV, HCV, HIV, or AIDS-related illnesses. The following are notes regarding specific infections: a. COVID-19/SARS-CoV-2: Study participants should be excluded if they test positive for SARS-CoV-2 infection, are known to be asymptomatic, or are suspected of SARS-CoV-2 infection, but may be rescreened as required by the protocol if the study participant subsequently tests negative. b. HIV History: In the absence of clarification, study participants with negative viral load may be eligible. HIV-seropositive study participants who are otherwise healthy and at low risk for AIDS-related outcomes may be eligible, as confirmed in discussion with the sponsor, but patients with AIDS should be excluded. c. HBV/HCV History: Relevant laboratory tests should be obtained at screening. Study participants who are HBsAg positive (i.e., acute or chronic active hepatitis) are excluded. Study participants who are HBV antibody positive are eligible. Study participants who are HBsAg negative, anti-HBc positive, and anti-HBs negative may be eligible for the study, depending on the clinical circumstances and subject to discussion with the sponsor. In this case, HBV PCR testing is recommended. Study participants whose clinical history and presentation suggest low-level chronic infection or who are in remission from an acute infection should be considered ineligible. Positive HCV antibodies are a marker of infection, but this does not necessarily mean that a potential candidate is ineligible, depending on the clinical circumstances. This should be discussed with the sponsor. If exposure to HCV was recent, HCV antibodies may not yet be detectable, in which case HCV RNA testing is recommended.
    • 19Baseline standard 12-lead ECG demonstrating clinically relevant abnormalities that may affect the safety of the study participant or the interpretation of study results (e.g., baseline QTcF > 470 ms, complete LBBB, signs of acute or unspecified myocardial infarction, ST segment and/or T wave changes suggestive of active myocardial ischemia, second or third degree atrioventricular block, or severe bradyarrhythmia or tachyarrhythmia).
    • 20Any of the following within the past 6 months: myocardial infarction, long QT syndrome, torsade de pointes, clinically significant atrial or ventricular arrhythmias (including sustained ventricular tachyarrhythmias and ventricular fibrillation), severe conduction system abnormalities (e.g., bifascicular block, third degree atrioventricular block), unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic CHF, New York Heart Association functional class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant thromboembolic events. NCI CTCAE grade ≥ 2 sustained arrhythmias, any grade of atrial fibrillation (≥ grade 2 asymptomatic atrial fibrillation). Study participants were considered potentially eligible if they had an implanted cardiac rhythm device/pacemaker and QTcF > 470 ms. For study participants with an implanted cardiac rhythm device/pacemaker, detailed discussion with the sponsor is required to determine eligibility.
    • twenty oneStudy site staff directly involved in the conduct of the study and their family members, study site staff otherwise supervised by the investigator, and employees of the sponsor and sponsor representatives directly involved in the conduct of the study and their family members.
    • twenty twoExclusion criteria for the cetuximab combination cohort were: known contraindications to cetuximab, including hypersensitivity reactions or toxicity indicating intolerance of the highest cetuximab dose of 500 mg/m2.
    • twenty threeExclusion criteria for the FOLFOX and bevacizumab combination cohort: Proteinuria urine dipstick result > 2+. Study participants with proteinuria ≥ 2+ by dipstick urinalysis at baseline should undergo a 24-hour urine collection and must show ≤ 1 g of protein in the 24 hours prior to starting dosing.
    • twenty fourExclusion criteria for the FOLFOX and bevacizumab combination cohort: serum albumin ≤ 3.0 g/dL
    • 25Exclusion criteria for the FOLFOX and bevacizumab combination cohort were radiation therapy within 28 days before cycle 1, day 1, and abdominal/pelvic radiation therapy within 60 days, except for palliative radiation therapy for bone lesions within 7 days before cycle 1, day 1.
    • 26Exclusion criteria for the FOLFOX and bevacizumab combination cohort: severe nonhealing or open wounds, active ulcers, or untreated fractures
    • 27Exclusion criteria for the pembrolizumab and pembrolizumab + platinum chemotherapy cohorts were: clinically significant multiple or severe drug allergies, intolerance to topical glucocorticoids, or severe hypersensitivity reactions after treatment (including but not limited to erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
    • 28Exclusion criteria for the pembrolizumab and pembrolizumab + platinum chemotherapy cohorts: Participation in any other pembrolizumab trial and prior treatment with pembrolizumab. Prior treatment with any other anti-PD-1 or PD-L1 or PD-L2 agents or antibodies targeting other immune regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR.
    • 29Study participants with symptomatic ascites or pleural effusion who were clinically stable after treatment of these conditions (including therapeutic thoracentesis or paracentesis) were eligible for the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Pancreas
    Bowel (Colorectal)
    Non-Small Cell Lung Cancer