araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Summary: This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/=18 years of age
  -  Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer
  -  At least 1 measurable disease lesion as per RECIST criteria
  -  Confirmed presence of EGFR in tumor tissue
  -  ECOG performance status 0-1
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Prior chemotherapy or treatment with another systemic anti-cancer agent
  -  Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
  -  Symptomatic or active CNS metastases
  -  Recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
  -  Requirement for steroids > 40 mg prednisolone

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Clinical Study to Evaluate the Maximum Tolerated Dose of BAY1000394 Given in a 3 Days on / 4 Days Off Schedule in Subjects With Advanced Malignancies

Summary: Clinical study to determine safety, tolerability, to measure how the drug is metabolized by the body and to determine the maximum tolerated dose of BAY1000394 given in an intermittent 3 days on / 4 days off schedule to patients with advanced malignancies


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  -  Life expectancy of at least 12 weeks
  -  Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable
  -  At least 1 tumor lesion measurable by computer tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1
  -  Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to the first dose of study drug
  Exclusion Criteria:
  -  History of cardiac disease: congestive heart failure > NYHA Class II, unstable angina (anginal symptoms at rest), any episodes of angina or history of myocardial infarction, cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted), previous venous or arterial thrombotic events, pulmonary embolism
  -  Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C(3)
  -  History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  -  Active clinically serious infections of CTCAE > Grade 2 (CTCAE v4.02)
  -  Symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. Subjects must not be on acute steroid therapy or taper off steroid therapy (chronic steroid therapy is acceptable provided that the dose is stable for 4 weeks prior to study entry and following screening CT / MRI scan). Subjects with neurological symptoms should undergo a CT / MRI scan of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable
  -  Seizure disorder requiring therapy (such as steroids or anti-epileptics)
  -  History of organ allograft
  -  Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE > Grade 2 within 4 weeks prior to prior to the first dose of study drug

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Biomarkers of Response in Blood and Tumor Tissue Samples From Patients With Unresectable Stage IV Squamous Cell Cancer of the Head and Neck Previously Treated With Cetuximab, Cisplatin, and Radiation Therapy

Summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
  PURPOSE: This research study is studying biomarkers of response in blood and tumor tissue samples from patients with unresectable stage IV squamous cell carcinoma of the head and neck previously treated with cetuximab, cisplatin, and radiation therapy.

Detailed description: OBJECTIVES:
  Primary
  -  To expand upon the list of molecular correlates indicated in clinical trial ECOG-E3303, including EGFR expression, EGFR phosphorylation, map kinase, AKT, and STAT3.
  -  To correlate the status or expression level of each biomarker with clinical outcome (response, progression-free survival, overall survival).
  OUTLINE: Archived tumor and blood specimens are analyzed for human papilloma virus and p16 status; EGFR gene amplification; levels of ERCC1, XPF, and c-Met proteins; expression and activation of several signaling pathways including PI3 kinase gene and mTOR; levels of ErbB2, ErbB3, P70S6 kinase, S6 , and Akt; expression of amphiregulin (AR), TGF-alpha (TGF-α), heparin-binding EGF-like growth factor (HB-EGF), EGF, epiregulin and c-Met ligand, and hepatocyte growth factor by fluorescence in situ hybridization (FISH), automated in situ quantitative measurements of protein analysis (AQUA), IHC, PCR, and ELISA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of squamous cell carcinoma of the head and neck
  -  Stage IV disease
  -  Unresectable disease
  -  Treated with cetuximab, cisplatin, and radiotherapy on clinical trial ECOG-E3303
  -  Archived blood and tumor tissue samples available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients

Summary: The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)


Eligibility: Inclusion Criteria:
  -  Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
  -  Histological confirmation of Breast Cancer with documented ER+ receptor status
  -  Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL
  -  Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.
  -  Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits
  Exclusion Criteria:
  -  Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.
  -  More than 1 prior regimen of chemotherapy for breast cancer
  -  ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
  -  History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.
  -  Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

Summary: This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.

Detailed description: Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.

Eligibility: Inclusion Criteria:
  -  Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
  -  At least 18 years of age.
  -  ECOG PS 0~1
  -  Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
  -  neutrophil ≥ 1.5 x 109 /L, Hemoglobin > 90 g/L, Platelet count > 100x109/L.
  -  Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST < 2.5 x upper limit of normal without liver metastasis, ALT and AST < 5 x upper limit of normal with liver metastasis. Serum creatinine < 1.5 x upper limit of normal.
  -  Urine pregnancy test is negative for woman.
  -  Estimated life expectancy is at least 3 months.
  -  Patient comply with the clinical trial protocal.
  -  Informed consent must be signed.
  Exclusion Criteria:
  -  Patients who are currently undergoing other anti-tumor therapy.
  -  Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
  -  Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
  -  Central nervous system (CNS) tumor or metastatic tumor.
  -  Serious mental disorder.
  -  Serious dysgnosia.
  -  Other serious comorbidity.
  -  Alcohol or drug dependence.
  -  Previously allergic to drugs used in the study.

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic or Recurrent Non-Squamous Non-Small Cell Lung Cancer

Summary: This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice. Data will be collected for each patient for 18 months from initiation of Avastin therapy.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)
  -  Treating physician's decision to initiate first-line Avastin treatment
  Exclusion Criteria:
  -  Participation in a clinical trial evaluating anti-cancer therapies

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer

Summary: This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
  -  Female patients ≥ 18 years old
  -  Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  -  At least one measurable lesion as per RECIST
  Exclusion Criteria:
  -  Previous treatment with an FGFR inhibitor
  -  More than one line of treatment for advanced or metastatic disease
  -  Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
  -  Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
  -  Known central nervous system (CNS) metastases
  -  Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO

Summary: To assess the impact of prophylactic treatment on the incidence of adverse events in advanced NSCLC patients (post chemotherapy) treated with dacomitinib daily as a single agent. To assess the impact of an interrupted dacomitinib dosing schedule in Cycle 1 on the incidence of adverse events in first-line advanced NSCLC patients with an EGFR mutation (HER-1 mutation, HER-2 mutation or HER-2 amplification).


Eligibility: Inclusion Criteria:
  -  Advanced Non-Small Cell Lung Cancer (NSCLC).
  -  For Cohort I and Cohort II, advanced NSCLC patients must have received at least one prior regimen of systemic therapy which includes at least one standard chemotherapy for advanced NSCLC and who have failed (ie, progressed or intolerant due to toxicity which precludes further treatment) standard therapy for advanced or metastatic disease. To be considered intolerant to treatment, a patient must have received at least two cycles to be considered previously treated.
  -  For Cohort III, advanced NSCLC patients must not have received prior systemic treatment for their advanced disease and require a known EGFR (HER-1) mutation, HER-2 mutation or HER-2 amplification. Cohort III patients could have received prior adjuvant chemotherapy for Stage I-III disease or combined modality chemotherapy-radiation for Stage IIIA disease is allowed if treatment completed>12 months prior to enrollment.
  -  All cohorts, patients must have evidence of disease; however, measurable disease is not required to enroll.
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  -  Estimated creatinine clearance ≥15 mL/min.
  Exclusion Criteria:
  -  Prior treatment with an EGFR-targeted or HER-targeted agent (all cohorts).
  -  Chemotherapy, radiotherapy, biological or investigational agents within 2 weeks of baseline disease assessments (all cohorts).
  -  Patients with known diffuse interstitial lung disease (all cohorts).
  -  Investigational therapy as only treatment for advanced NSCLC without administration of an approved chemotherapy for advanced NSCLC (for Cohort I and Cohort II)

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Concurrent Nab-P/Carboplatin and Thoracic Radiotherapy in Squamous Cell Lung Cancer

Summary: Nab-paclitaxel and carboplatin showed better treatment response compared with cremophor-based paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer, especially for squamous cell cancer. The regimen of weekly nab-paclitaxel, carboplatin and concurrent radiotherapy was well tolerated in a phase I study. Given nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced squamous cell lung cancer may have promising result.

Detailed description: This study was conducted to explore the efficacy and toxicity of concurrent chemoradiotherapy with nab-paclitaxel, carboplatin and thoracic radiotherapy in unresectable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 60mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 66 Gy/33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed. Two cycles of consolidation therapy with full dose nab-paclitaxel (260 mg/m2 on day 1) and carboplatin (AUC 6 on day 1) every 21 day will be delivered.

Eligibility: Inclusion Criteria:
  -  Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  -  Previously untreated, histological documented, inoperable stage IIIA or IIIB squamous cell carcinoma of lung, excluding those with pericardial, pleural effusion, and those with contralateral hilar or contralateral supraclavicular lymph nodes.
  -  Patients must have measurable disease according to RECIST criteria, and all detectable tumor can be encompassed by radiation therapy fields.
  -  Weight loss ≦ 5% in the previous six months.
  -  Patient must have adequate blood, liver, lungs and kidney function within the requirements of this study.
  -  Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. Male and female patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
  -  Patients must sign a study-specific informed consent form prior to study entry.
  Exclusion Criteria:
  -  Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  -  Previous chemotherapy or previous biologic response modifiers for current lung cancer.
  -  Patient has previously had thoracic radiation therapy.
  -  Prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for five years or more.
  -  Serious concomitant disorders that would compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
  -  History of significant neurological or mental disorder, including seizures or dementia.

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Summary: 1. Trial design: Prospective observational study
  2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
  3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
  -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
  4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
  5. Duration of Trial Recruitment: 2 years


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  19~80 year old male or female
  -  Histologically proven advanced or metastatic NSCLC
  -  Failed to 1st line chemotherapy
  -  Tumor tissue for genetic analysis
  -  Evaluable target lesion by RECIST v1.1
  -  ECOG performance from 0 to 3
  -  Expected survival more than 12 weeks
  Exclusion Criteria:
  -  Previous treatment of EGFR-tyrosine kinase inhibitors
  -  Severe hypersensitivity to erlotinib
  -  Residual toxicities (above grade 2) after previous chemotherapy
  -  Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Relevance to patient case: not relevant
Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

Clinical trial: Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

Summary: This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

Detailed description: We will compare the concentration of free fatty acids and their metabolites between patients with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy will be assessed for potential predictors.

Eligibility: Inclusion Criteria:
  -  Age from 40 to 80
  -  Lung adenocarcinoma with pathological diagnosis
  -  Lung squamous cell carcinoma with pathological diagnosis
  -  Control patients should have at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.
  Exclusion Criteria:
  - Lung cancer patient without serum sample before the initiation of treatment

Relevance to patient case: not relevant