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

Clinical trial: XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach

Summary: To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.

Detailed description: To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.

Eligibility: Inclusion Criteria:
  -  Ages Eligible for Study: 65 Years or older
  -  Genders Eligible for Study: Both
  -  The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  -  Histologically confirmed gastric adenocarcinoma(including LAUREN type).
  -  Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
  -  chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
  -  Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
  -  No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
  -  Able to accept oral medication
  -  Compliance with protocol
  Exclusion Criteria:
  -  Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
  -  Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
  -  Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
  -  clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
  -  Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
  -  Organ transplantation requires immunosuppressive treatment.
  -  Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
  -  Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
  -  Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
  -  Allergy to Oxaliplatin or any study medication ingredients.

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

Clinical trial: VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer

Summary: a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

Detailed description: 1. non small cell lung cancer (non squamous carcinoma)
  2. ECOG 0-1
  3. from 18-75 years old

Eligibility: Inclusion Criteria:
  -  non squamous cell non small cell lung cancer
  -  with measurable disease
  -  ECOG 0-1
  Exclusion Criteria:
  - patients received surgery in recent 4 weeks

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 PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility: Inclusion Criteria:
  -  KRAS and NRAS wild type metastatic colorectal cancer
  -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  -  Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  -  Prior radiation to the pelvis or abdomen
  -  Patients with history of interstitial lung disease.

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

Clinical trial: Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Summary: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Detailed description: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Eligibility: Inclusion Criteria:
  -  Provision of signed, written and dated informed consent prior to any study specific procedures
  -  Male or female, aged 18 years or older
  -  Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  -  KRAS mutation positive tumour sample as determined by the designated testing laboratory
  -  Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
  Exclusion Criteria:
  -  Mixed small cell and non-small cell lung cancer histology.
  -  Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
  -  Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  -  Other concomitant anti-cancer therapy agents excepts steroids
  -  Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  -  Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

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 Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Summary: This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.
  The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.


Eligibility: Inclusion Criteria:
  -  Advanced colorectal carcinoma.
  -  Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
  -  Tumor tissue available at time of screening for molecular profiling.
  -  Adequate performance status.
  -  Adequate glucose control, bone marrow, kidney, liver, and heart function.
  Exclusion Criteria:
  -  Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
  -  Prior irinotecan treatment.
  -  Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
  -  History of Gilbert's syndrome.
  -  Active brain metastases.
  -  Deep vein thrombosis in the preceding 2 months.
  -  History of interstitial lung disease.
  -  RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).

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

Clinical trial: Safety and Pharmacokinetics of Regorafenib and Cetuximab in Combination

Summary: To establish safety, tolerability and pharmacokinetics of regorafenib and cetuximab in combination, and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)


Eligibility: Inclusion Criteria:
  -  Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors who are not candidates for standard therapy or in whom regorafenib or cetuximab is considered a standard treatment. Patients with metastatic colorectal cancer (mCRC) must have a record of K-ras gene mutational analysis available and no K-ras mutation is present.
  -  Male or female patients ≥ 18 years of age
  -  Women of childbearing potential must have a blood or urine pregnancy test performed a maximum of 7 days before start of study treatment, and a negative result must be documented before start of study treatment
  -  Life expectancy of at least 3 months
  -  Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting the study treatment:
  -  Platelet count ≥ 100,000/cubic millimeters (mm3), hemoglobin (Hb) ≥ 8.5 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,000/mm3
  -  Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Mildly elevated total bilirubin (< 6 mg/dL) is allowed if Gilbert's syndrome is documented.
  -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  -  Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects whose cancer involves their liver).
  -  Amylase and lipase ≤ 1.5 x ULN
  -  Serum creatinine ≤ 1.5 times ULN and creatinine clearance (CLcr) ≥ 30 mL/min according to the Cockroft-Gault formula
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  Exclusion Criteria:
  -  Prior treatment with Regorafenib
  -  Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
  -  Non-healing wound, ulcer, or bone fracture
  -  Systemic anticancer therapy within 28 days
  -  Patients unable to swallow and retain oral medications

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 MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS

Summary: This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability and pharmacokinetics of intravenous (IV) dosing of MEHD7945A in combination with oral dosing of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation and for which standard therapies do not exist, have proven ineffective or intolerable or are considered inappropriate. The study comprises a dose-escalation (Stage 1) and an indication-specific cohort expansion stage (Stage 2).


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic solid KRAS-mutant tumors, for which standard therapies do not exist, have proven ineffective or intolerable or are considered inappropriate
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  -  Evaluable disease or disease measurable per modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  -  Consent to provide archival tumor tissue for biomarker testing
  -  Additionally, for patients who are considered for enrollment into the indication specific expansion cohorts in Stage 2, the current cancer must be either KRAS-mutant colorectal cancer (CRC) or KRAS-mutant non-small cell lung cancer (NSCLC)
  Exclusion Criteria:
  -  History of prior significant toxicity from another MEK pathway inhibitor or combination of another MEK and epidermal growth factor receptor (EGFR) inhibitor requiring discontinuation of treatment
  -  Previous treatment with a combination of a MEK inhibitor with an EGFR inhibitor (applies only to the indication specific expansion cohorts in Stage 2)
  -  Allergy or hypersensitivity to components of the cobimetinib formulations
  -  History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy
  -  History of interstitial lung disease (ILD)
  -  Known severe ulcer disease
  -  History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioetinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
  Patients will be excluded if they currently have either of the following conditions which have been identified as risk factors for CSCR:
  -  Uncontrolled glaucoma with intraocular pressure greater than (>) 21 millimeters of mercury (mm Hg)
  -  Grade greater than equal to (>=) 3 hypertriglyceridemia

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

Clinical trial: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Summary: This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.


Eligibility: Inclusion Criteria:
  -  Histological or cytological proof of advanced non-small cell lung cancer
  -  Written documentation of KRAS (exon 2, 3 or 4) mutation
  -  At least 18 years of age or older
  -  Able and willing to give written informed consent
  -  WHO performance status of 0 or 1
  Exclusion Criteria:
  -  Symptomatic or untreated leptomeningeal disease
  -  Symptomatic brain metastasis
  -  Impairment of gastrointestinal function
  -  Uncontrolled infectious disease
  -  Left ventricular ejection fraction < 50%
  -  Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Summary: Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
  Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
  The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


Eligibility: Inclusion Criteria:
  -  Patient is male or female, and > 18 years of age
  -  Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
  -  Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
  -  Patient has agree to participate by giving written informed consent
  Exclusion Criteria:
  -  metastatic pancreatic tumor
  -  cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
  -  minor patient under 18 years
  -  contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
  -  patient under guardianship
  -  Pregnant or lactating women

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

Clinical trial: Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Detailed description: This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care.
  Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Eligibility: Inclusion Criteria:
  -  Written informed consent obtained before undergoing any study-related activities
  -  Male or female, at least 18 years of age
  -  Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
  -  Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
  -  Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
  -  Measurable disease defined as one or more target lesions according to RECIST
  -  Life expectancy of at least 3 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
  -  Other protocol defined inclusion criteria could apply
  Exclusion Criteria:
  -  Pretreatment with regorafenib.
  -  Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
  -  Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
  -  Magnesium less than 0.9 milligram per deciliter (mg/dL)
  -  Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
  -  Other protocol defined exclusion criteria could apply

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

Clinical trial: Panitumumab for Intravenous Infusion 100 mg and 400 mg Special Drug Use Surveillance "Survey on Unresectable, Advanced or Recurrent Colorectal Cancer With Wild-type KRAS Gene" (All-patient Surveillance)

Summary: The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.
  Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.

Detailed description: The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.
  Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.
  The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.

Eligibility: Inclusion Criteria:
  -  Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
  Exclusion Criteria:
  -  Patients with a medical history of severe hypersensitivity to any of the ingredients of Vectibix

Relevance to patient case: not relevant