araag2/TREC_Precision-Medicine huggingface dataset:
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. This study is conducted to evaluate the efficacy and safety of nab-paclitaxel, carboplatin and concurrent radiotherapy in patients with local advanced inoperable squamous cell lung cancer.

Detailed description: This study was conducted to explore the efficacy and safety of concurrent concurrent nab-paclitaxel, carboplatin and thoracic radiotherapy in inoperable local advanced squamous cell lung cancer. Patients will be given nab-paclitaxel weekly at a dose of 40mg/m2, in combination with carboplatin (AUC 2) weekly during concurrent chemoradiotherapy. Thoracic radiation was administered at a dose of 60-66 Gy/30-33 fractions, both 3 dimensional conformal and intensity modulated radiation therapy are allowed.

Eligibility: Inclusion Criteria:
  -  Age: 18 Years to 70 Years
  -  Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  -  Previously untreated, histological documented, inoperable stage III 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.
  -  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: Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations

Summary: Open-label, Phase 2, single treatment arm, 2 cohorts


Eligibility: Key Inclusion Criteria:
  -  Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease
  -  Progression of disease on or after a platinum-based chemotherapy regimen
  -  EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B)
  -  Measurable disease according to RECIST v.1.1
  -  ECOG performance status of 0 or 1
  -  Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
  -  Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
  -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
  -  Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
  -  Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
  -  Platelet count ≥ 100,000/μL
  -  No evidence of second or third degree atrioventricular block
  -  No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration, SVT > 4 beats/minute)
  -  QRS interval ≤ 110 ms
  -  QTcF interval of < 450 ms
  -  PR interval ≤ 200 ms
  -  Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides)
  Key Exclusion Criteria:
  -  Another known activating oncogene driver mutation
  -  Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
  -  Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
  -  Investigational therapy administered within the 28 days or 5 half lives
  -  Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
  -  Immunotherapy within 21 days
  -  Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
  -  Untreated and/or symptomatic CNS malignancies (primary or metastatic);
  -  Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
  -  Personal or familial history of Long QT Syndrome
  -  NYHA class III or IV or LVEF < 55%
  -  Myocardial infarction, severe or unstable angina within 6 months
  -  History of TdP, ventricular arrhythmia
  -  Significant thrombotic or embolic events within 3 months
  -  Uncontrolled or severe cardiovascular disease
  -  Concurrent malignancy expected to require treatment within 2 years or interfere with study outcomes
  -  History of severe allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition as tarloxotinib
  -  Known HIV infection or active Hepatitis B or C

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

Clinical trial: Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)

Summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.


Eligibility: Inclusion Criteria:
  -  Cytologically or histologically confirmed advanced solid tumor
  -  Radiographic progression on prior systemic therapy; prior localized therapy (i.e., radiation, ablation, embolization) is allowed provided radiographic progression out-of-field or in the treatment, field is shown
  -  Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene fusion/rearrangement potentially leading to a functional FGFR aberrant protein, identified through local and/or central molecular assay
  Exclusion Criteria:
  -  History of hypersensitivity to any of the excipients in the Debio 1347 formulation
  -  History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon calcifications
  -  Administration of any investigational agent within 2 weeks prior to initial dosing with Debio 1347 (3 weeks for immune checkpoint inhibitors)

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

Clinical trial: Evaluating Mutations in MET and TP53 Among Patients Diagnosed With Squamous Cell Carcinoma

Summary: This study focuses on advanced lung and head and neck SCC tumours, with adjacent normal lung tissues. Biopsies will be performed in National University Health System, Singapore (NUHS) as part of participants' standard care. Patient blood was also required for extraction of cell free DNA (cfDNA) and genomic DNA (gDNA). Patients' medical records will also be reviewed for the purpose of this study.

Detailed description: Primary objective:
  To investigate the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in lung and head and neck tumours, through prospective collection of tumour specimens in newly recruited patients.
  Secondary objectives:
  1. To distinguish the presence of somatic/germline MET and TP53 mutation in lung and head and neck tumours.
  2. To detect for amplifications of MET and/or HER2 genes in SCC samples.
  3. To investigate the association and interaction of cMet and HER2 in SCC tumours.
  4. To establish a prospective documation of clinical, histopathological, treatment and follow-up (clinic pathological) data of newly recruited patients.

Eligibility: Inclusion Criteria:
  1. Age 18 years or older
  2. Histologic or cytologic confirmation of metastatic squamous cell carcinoma of the lung or head and neck region
  3. No other active malignancy within the past 24 months
  4. Refractory disease
  Exclusion Criteria:
  1. Patient with other active malignancy within the past 24 months
  2. Unable or unwilling to provide signed informed consent

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

Clinical trial: Afatinib as 2nd-line Treatment of Patients With EGFR Overexpression or EGFR Amplification ESCC (ESCC-A01)

Summary: This is a phase 2 trial investigating the effect of afatinib as second-line treatment of patients with EGFR overexpression or EGFR amplification esophageal Squamous Cell Carcinoma.


Eligibility: Inclusion Criteria:
  1. Having signed informed consent.
  2. Age 18 to 70 years old.
  3. Histologically confirmed esophageal squamous carcinoma
  4. Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
  5. Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
  6. Failed to first-line treatment.
  7. Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
  8. Life expectancy of ≥3 month
  9. Eastern Cooperative Oncology Group (ECOG) 0-2
  10. WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  11. No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever＞38℃.
  12. Good compliance
  Exclusion Criteria:
  1. Contraindications of afatinib.
  2. Unable to take afatinib orally because of esophageal stenosis.
  3. Currently receiving other effective regimens.
  4. Previous anticipate other clinical trial within 4 weeks before entering this study.
  5. No measurable lesions, eg. pleural fluid and ascites.
  6. With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
  7. Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
  8. Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
  9. HIV infection, active hepatitis B or hepatitis C.
  10. Unstable systemic diseases such as poorly controlled diabetes.
  11. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
  12. Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
  13. Pregnancy or lactation period.
  14. Active severe infection within 14 days.

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

Clinical trial: K-RAS and EGFR in Lung Cancer

Summary: Retrospective analysis where patients with histologically confirmed Non-small cell lung cancer (NSCLC) were centrally evaluated for the presence of KRAS and EGFR mutations.

Detailed description: A retrospective analysis, performed by the Hellenic Co-operative Oncology Group (HeCOG), in samples from patients with histologically confirmed NSCLC, who had been treated within HeCOG-affiliated centres from March 2000 through December 2012, were centrally evaluated for the presence of KRAS and EGFR mutations. All patients had available clinicopathological data at diagnosis. Formalin-fixed, paraffin-embedded tissue blocks were retrospectively retrieved from the HeCOG tumor repository. Cytologic material was prospectively submitted for genotyping in more recent years (2010-2012).

Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed NSCLC
  -  Signed and dated written informed consent
  -  Age 18 years
  -  Available cytological material
  Exclusion Criteria: -

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 Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.

Detailed description: OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients.
  OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.

Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed stage IIIA non-small cell lung cancer that has been completely resected by lobectomy, bilobectomy, pneumonectomy, or sleeve lobectomy through any incision (thoracoscopic or video assisted resection is acceptable) No known residual disease present Involvement in N2 nodes must have been determined only at the time of surgical exploration or by postoperative pathologic diagnosis All grossly involved nodes must be removed at surgery No positive mediastinoscopy (if lymph nodes on CT scan are greater than 1.5 cm in diameter, mediastinoscopy is required)
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ZUBROD 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing
  PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent growth factors Chemotherapy: No prior chemotherapy for non-small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure Hormones for nondisease related conditions Dexamethasone as an antiemetic Radiation therapy: No prior radiotherapy for non-small cell lung cancer Surgery: See Disease Characteristics

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

Clinical trial: Video-Assisted Surgery in Treating Patients With Non-small Cell Lung Cancer

Summary: RATIONALE: Video-assisted surgery may be an effective treatment and have fewer side effects than conventional surgery in patients with non-small cell lung cancer.
  PURPOSE: Phase II trial to study the effectiveness of video-assisted surgery in treating patients who have non-small cell lung cancer.

Detailed description: OBJECTIVES: I. Determine the feasibility of performing video-assisted thoracic surgery (VATS) lobectomy, without significant morbidity or perioperative mortality, in patients with small (no greater than 3.0 cm), peripheral, non-small cell lung cancer. II. Determine the rate at which a thoracotomy must be carried out to complete a VATS lobectomy in these patients. III. Describe the complications associated with this procedure. IV. Describe the length of the operative procedure, duration of chest tube stay, and length of hospitalization in this patient population. V. Describe the survival and failure-free survival, over a 5-year period, in this patient population following this procedure.
  OUTLINE: Patients undergo video-assisted thoracic surgery (VATS) lobectomy, which requires 3 small incisions on the side of the chest. The entire anatomic pulmonary lobe is removed, as well as all peribronchial lymph nodes and anterior hilar lymph nodes. If it is not possible to remove the lobe using the VATS approach, then 1 of the incisions is converted to a standard thoracotomy. Patients are followed every 4 months for the first 2 years, and then every 6 months for the next 3 years.
  PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 3 years.

Eligibility: DISEASE CHARACTERISTICS: Suspected or histologically documented non-small cell lung cancer Solitary, peripheral lung lesion that is no greater than 3.0 cm No metastatic disease No positive lymph nodes at mediastinoscopy At least 5 years since diagnosis of non-small cell or small cell lung cancer
  PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: FEV1 at least 1.0 L or at least 50% of predicted Other: No significant comorbid medical or psychiatric condition No other active malignancy other than nonmelanomatous skin cancer
  PRIOR CONCURRENT THERAPY: Not specified

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

Clinical trial: Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

Summary: RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
  -  Determine the treatment-related toxicity in patients treated with this therapy.
  -  Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.
  OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.
  PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant non-small cell lung cancer (NSCLC)
  -  Intraoperative needle biopsy confirmation allowed
  -  Resectable disease (stage I or II)
  -  All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
  -  Medically fit to undergo lung resection
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 18
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior or concurrent biologic therapy
  Chemotherapy:
  -  No prior or concurrent chemotherapy
  Endocrine therapy:
  -  No prior or concurrent endocrine therapy
  Radiotherapy:
  -  No prior or concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No other prior therapy for NSCLC

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

Clinical trial: Oxaliplatin in Combination With Capecitabine and Concurrent Radiation Therapy in Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine the most suitable dose of Oxaliplatin that can be safely given in combination with a low fixed dose of Capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

Detailed description: The purpose of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of Oxaliplatin in combination with Capecitabine and radiation in subjects with non-small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  histologically proven non-small cell lung cancer
  -  inoperable Stage III A or B NSCLC
  -  must have measurable disease by RECIST criteria
  -  no more than one prior chemotherapy for advanced disease
  -  ECOG Performance Status of 0, 1, or 2
  -  must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption
  -  negative serum beta-HCG test and under active contraception (for females of childbearing potential)
  -  no known allergies to any of the study drugs
  -  willingness to sign an informed consent
  Exclusion Criteria:
  -  women who are pregnant or breastfeeding
  -  ANC of less than 1500/mm3
  -  platelet count of less than 100,000/mm3
  -  estimated creatinine clearance of less than 50 cc/min (as measured by the Cockcroft-Gault equation)
  -  bilirubin of less than 2mg/dl
  -  SGPT of greater than 2x nl
  -  peripheral neuropathy of Grade 2 or higher
  -  more than one previous chemotherapy and previous radiation therapy to the chest
  -  a history of CHF/MI or other significant cardiac history within the last six months

Relevance to patient case: not relevant