araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
  -  Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  -  Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  -  Men or women 18 years of age or older
  -  Adequate hematologic, renal, hepatic, metabolic, and coagulation function
  Exclusion Criteria:
  -  History of prior or concurrent central nervous system (CNS) metastases
  -  Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  -  Clinically significant cardiac disease
  -  Clinically significant peripheral sensory neuropathy
  -  Active inflammatory bowel disease
  -  Recent gastroduodenal ulcer to be active or uncontrolled
  -  History of interstitial lung disease
  -  Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  -  Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  -  Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Blood Samples From Patients With Non-Small Cell Lung Cancer and From Healthy Volunteers

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with non-small cell lung cancer and from healthy volunteers.

Detailed description: OBJECTIVES:
  -  Measure plasma cathepsin D levels in patients with non-small cell lung cancer and in healthy volunteers using mass spectometry.
  -  Measure fatty acid synthase levels in these patients and healthy volunteers using mass spectometry.
  OUTLINE: Blood samples are collected from patients and healthy volunteers to measure the levels of cathepsin D and fatty acid synthase by proteomic profiling and mass spectrometry.

Eligibility: Inclusion Criteria:
  Non-Small Cell Lung Cancer Patients
  -  Documented diagnosis of non-small cell lung cancer, any stage and any time point in the course of treatment (i.e., at diagnosis, during any treatment, and during post treatment surveillance)
  -  Measurable disease by CT scan within the past 4 weeks
  Healthy volunteer
  -  Non-smoking, defined as < 5 packs/year history of smoking and cessation of smoking ≥ 6 months ago OR a never smoker
  -  Not regularly exposed (i.e., daily) to second-hand smoke
  Exclusion Criteria:
  -  Severe underlying lung disease (i.e., chronic obstructive pulmonary disease with FEV_1 < 1.0 L, pulmonary fibrosis, bronchiectasis, cystic fibrosis, etc.) as determined by enrolling researcher.
  Written consent must be given for both subjects and controls.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Epidermal Growth Factor Receptor and K-ras Mutations in Patients With Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations and k-ras oncogene mutations in patients with stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the frequency of epidermal growth factor receptor (EGFR) and K-ras mutations in patients with stage III non-small cell lung cancer (NSCLC) treated on CALGB 30106.
  -  Correlate presence or absence of EGFR and/or K-ras mutations with radiographic response to treatment in these patients.
  OUTLINE: Tissue samples are analyzed for epidermal growth factor receptor and K-ras mutations.

Eligibility: Inclusion criteria:
  1. Eligible patients had histologic documentation of un- treated stage III NSCLC.
  2. Radiation oncologist confirmation was required that radiation could be given per protocol.
  3. Eastern Cooperative Group Criteria Performance Status of 0 to 2
  4. Tumor specimen paraffin block or unstained slides and standard initial laboratory tests
  5. Signed institutional review board-approved, protocol-specific in- formed consent in accordance with federal and institutional guidelines
  Exclusion criteria:
  1. Patients with scalene, supraclavicular, or contralateral hilar lymph node involvement, or direct invasion of the vertebral body or with a pleural effusion were ineligible.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

Summary: The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective


Eligibility: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
  Inclusion Criteria:
  -  ECOG status 0 - 1
  -  Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
  -  Dose expansion: CRC (KRAS-WT) and head & neck cancer subjects only
  1. must be able to provide 2 fresh tumor biopsy samples
  2. must have failed one prior cetuximab-containing treatment
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
  -  Any condition requiring chronic use of steroids
  -  Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
  -  History of glucose intolerance
  -  History of cetuximab infusion reactions
  -  Women of child-bearing potential unwilling or unable to use acceptable contraception methods

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Summary: The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
  -  Tumour sample (block of slides) available for KRAS analysis
  Exclusion Criteria:
  -  Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
  -  Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Summary: A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description: Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.
  Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Eligibility: Inclusion Criteria:
  -  Patients with locally advanced or metastatic non-small cell lung cancer.
  -  Patients must be >/= 18 years of age.
  -  Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.
  Exclusion Criteria:
  -  Patients with a recent history (within 5 years) of another malignancy.
  -  Patients who are pregnant or nursing.
  -  Patients with clinically significant heart failure.
  -  Patients with clinically significant eye or gastrointestinal abnormalities.

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer

Summary: The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Detailed description: Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
  Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
  -  Patients with central tumors located at the origin of a lobar bronchus.
  -  ECOG performance status 0-1
  -  Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
  -  Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
  -  Renal: Creatinine clearance greater than 60 ml/min
  -  Cardiovascular: Cardiac function normal
  Exclusion Criteria:
  -  Severe complications or infections
  -  Pregnant or breast-feeding women
  -  Clinically significant heart disease
  -  Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
  -  Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

Relevance to patient case: not relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Combination Therapy Study of MK-2206 and AZD6244 in Participants With Advanced Solid Tumors (MK-2206-010)

Summary: This study will investigate the safety and tolerability of combination therapy with MK-2206 and AZD6244 (selumetinib) and determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RPTD) for this drug combination in the treatment of participants with locally advanced or metastatic solid tumors. Preliminary efficacy data will also be collected.
  The primary hypotheses for this study are that: 1) the Dose-limiting Toxicities (DLTs) observed in participants with locally advanced or metastatic solid tumors after administration of combination therapy with MK-2206 and AZD6244 will be dose-dependent and allow for identification of the MTD, and 2) oral administration of combination therapy with MK-2206 and AZD6244 to participants with advanced solid tumors will be generally well-tolerated.


Eligibility: Inclusion Criteria:
  -  Participant has confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or therapies known to provide clinical benefit, or for whom efficacious standard therapy or any other therapy known to provide clinical benefit does not exist
  -  Participant has no history of prior cancer, except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no evidence of disease for 5 years
  -  At least 18 years of age
  -  Participant is able to swallow oral medications
  -  For participants enrolled in the MTD expansion cohorts, must have a diagnosis of Kirsten rat sarcoma viral oncogene homolog (KRAS) tumor-type non small-cell lung cancer (NSCLC). Additional tumor types (with specific mutations) may be added to the MTD expansion cohorts after discussion between Sponsor and Investigator
  Exclusion Criteria:
  -  Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks of entering the study
  -  Participant is currently participating in or has participated in a study of an investigational compound or device within 30 days or 5x the compound's half-life of Cycle 1, Day 1
  -  Participant has known central nervous system metastases and/or carcinomatous meningitis
  -  Participant has a primary central nervous system tumor or spinal cord compression
  -  Participant is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse
  -  Participant is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study
  -  Participant is human immunodeficiency virus (HIV) positive
  -  Participant is has history of hepatitis B or C or active hepatitis A
  -  Participant has a history or current evidence of heart disease
  -  Participant has uncontrolled high blood pressure
  -  Participant has poorly controlled diabetes

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Study in Ovarian, Non-Small Cell Lung, Prostate, Colorectal, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck

Summary: The purpose of the study is to estimate the rate of response for patients with ovarian, non-small cell lung, prostate, colorectal, gastroesophageal, and head and neck cancers who are administered LY2523355.


Eligibility: Inclusion Criteria:
  -  Diagnosis of ovarian, non-small cell lung, prostate, colorectal, gastroesophageal cancer (adenocarcinoma of the esophageal cancer, stomach, or gastroesophageal junction), or squamous cell cancer of the head and neck
  -  Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines (except prostate cancer participants)
  -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Are willing to follow study procedures for the duration of the study
  -  Are willing to use an approved contraceptive method during treatment and for 3 months after discontinuation of study treatment
  Exclusion Criteria:
  -  Have a serious preexisting medical condition that would preclude participation in the study
  -  Are pregnant or lactating
  -  Have received treatment within 28 days of first dose of LY2523355 with a drug that has not received regulatory approval for any indication
  -  Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases
  -  Have a second active primary malignancy or a history of a second malignancy requiring cytotoxic therapy
  -  Have QTc interval greater than 470 millisecond (msec) or intraventricular conduction delay (IVCD) with QRS greater than 120 msec on screening electrocardiogram (ECG)
  -  Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral (A, B, C) hepatitis
  -  Participants with pneumonia, evidence of obstructive pneumonitis, other respiratory infections, or infection from other sources are to be excluded

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

Clinical trial: A Retrospective Study of Biomarkers in Non-Small Cell Lung Cancer

Summary: The purpose of this study is:
  1. To characterize the types and frequency of molecular alterations to the epidermal growth factor receptor (EGFR) pathway, FGFR4 and EML-ALK in Asian patients with non-small cell lung cancer
  2. To identify candidate biomarkers of importance in the EGFR and estrogen pathways
  Most, if not all, human malignancies including lung cancer are caused by somatic alterations of the genome, leading to activation of oncogenes or inactivation of tumor suppressor genes and their resultant oncogenic effects. In addition to mutations, increased chromosomal copy number (by amplification or polysomy) and DNA methylation are other mechanisms of oncogene activation and tumour suppressor gene inactivation respectively.
  Little is known about the relationship between these oncogenes of the EGFR family and the recently described oncogenes FGFR4 and fusion gene EML4-ALK. Recent data suggests molecularly defined subgroups of non-small cell lung cancer (NSCLC) exist and can be used to predict for sensitivity to targeted agents (erlotinib or gefitinib) or cytotoxic chemotherapy (pemetrexate, gemcitabine, platinum agents). The findings that estrogen receptors are present in lung tumours and that estrogen can stimulate growth and proliferation of lung cancers in vitro and in vivo are provocative. Further studies to evaluate the role of estrogens and other sex hormones in lung cancer are warranted.
  A further understanding of the molecular indicators of lung cancer prognosis and treatment prediction would improve drug development and patient treatment selection.
  Archived paraffin-embedded and fresh frozen NSCLC tumor tissue will be obtained via the Department of Pathology and the National University Tissue Repository respectively. Clinico-pathological characteristics will be obtained from the case records, Pathology and Tissue Repository. DNA will be isolated using standard techniques. Sequencing of genes in the EGFR signaling pathway: EGFR, KRAS, ErbB2, ErbB3, MET, PI3K, and BRAF as well as FGFR4. Unstained slides from the paraffin-embedded tissue will be obtained and subjected to fluoresce in vitro hybridization (FISH) for breakpoints in the EML4 and ALK genes as previously described. For cases that have been snap-frozen, RNA will be extracted and EML4-ALK fusions will be confirmed using RT-PCR and pre-specified primers. To analyse the expression of proteins of putative relevance to EGFR function (such as EGFR, ErbB2, ErbB3, AKT, MET, STAT, ERK, MAPK, cyclin D1, C/EBPa), downstream effects of EGFR: cell proliferation (Ki-67), angiogenesis (CD34, VEGF-A), apoptosis (bcl-2), metastasis, and hormonal influence (oestrogen and progesterone receptors, aromatase), TMA technology will be utilised. The status of the tumor suppressor genes PTEN and C/EBPa will be analysed.


Eligibility: Inclusion Criteria:
  -  Nil
  Exclusion Criteria:
  -  Nil

Relevance to patient case: not relevant