araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment.
  -  Availability of an archival FFPE tissue specimen.
  -  No prior systemic NSCLC treatment.
  -  ECOG PS 0, 1, or 2.
  -  Age ≥18 years .
  -  Adequate Bone Marrow, Liver, Renal, Pancreatic Function
  -  Negative pregnancy test for females of childbearing potential
  Exclusion Criteria:
  -  Spinal cord compression unless good pain control attained
  -  Major surgery within 4 weeks prior to randomization.
  -  Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
  -  Active bacterial, fungal, or viral infection
  -  Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
  -  Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
  -  History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
  -  Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization.
  -  Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib.
  1. known strong CYP3A inhibitors .
  2. known strong CYP3A inducers
  3. known P gp substrates with a narrow therapeutic index
  -  Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
  -  Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
  -  Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study.
  -  Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

Summary: To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.

Detailed description: In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.

Eligibility: Inclusion Criteria:
  -  Provision of informed consent
  -  Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
  -  ECOG performance status 0-2 with expected more than 6 months of survival time
  -  Willingness to comply with required protocols and give permission to use the data for clinical research and products development
  Exclusion Criteria:
  -  Patients have other primary cancers
  -  Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
  -  Patients failed in either plasma or tissue sample QC

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions

Summary: Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.


Eligibility: Inclusion Criteria:
  -  Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
  -  Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
  -  Willing and able to provide written, signed informed consent
  -  Medically suitable for treatment with entrectinib (RXDX-101)
  Exclusion Criteria:
  -  Currently enrolled in an ongoing clinical study with any other investigational agent

Relevance to patient case: definitely relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib

Summary: The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated with curative intent.


Eligibility: Inclusion Criteria:
  -  Pathologic evidence of advanced stage IV or recurrent lung adenocarcinoma reviewed at MSKCC
  -  Somatic activating mutation in EGFR Radiographic progression during treatment with erlotinib.
  -  Any number of prior chemotherapy regimens is permitted.
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  KPS >/= 70%
  -  Age >18 years old
  -  Must have undergone biopsy after development of acquired resistance to erlotinib with available archived tissue (equivalent of > 10 unstained slides)
  -  Left ventricular Ejection Fraction >/= the lower limit of normal by ECHO or MUGA
  -  Adequate organ function:
  -  AST, ALT </= 2.5 x ULN
  -  Total bilirubin </= 1.5 x ULN
  -  Albumin>/=2.6g/dL - Creatinine < 1.5 x ULN OR calculated creatinine clearance >/=50mL/min
  -  Absolute neutrophil count (ANC) >/= 1,200 cells/mm3
  -  Hemoglobin>/=9.0 g/dL
  -  Platelets >/=100,000/mm3
  Exclusion Criteria:
  -  Patients with symptomatic brain metastasis requiring escalating doses of steroids
  -  Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management due to medications or a medical condition such as Crohn's disease or malabsorption
  -  Pregnant or lactating women
  -  Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol except for a EGFR TKI
  -  Patients who have received prior treatment with a MEK inhibitor
  -  Any major surgery or extensive radiotherapy within 21 days of starting treatment on protocol.
  -  A history of clinically significant interstitial lung disease or pneumonitis
  -  Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study administration, New York Heart Association Class III or IV congestive heart failure, or symptomatic uncontrolled Arrythmias, prolonged corrected QT interval >480msec, treatment refractory hypertension, presence of a cardiac defibrillator
  -  History of central serous retinopathy or retinal vein occlusion

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements

Summary: Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation scheme, and determine the recommended phase 2 dose.
  Phase 2 will assess safety and efficacy of TPX-0005.


Eligibility: Key Inclusion Criteria:
  1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
  2. ECOG PS 0-1.
  3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
  4. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
  5. Prior cytotoxic chemotherapy is allowed.
  6. Prior immunotherapy is allowed.
  7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  8. Patients with asymptomatic CNS involvement are allowed.
  9. Life expectancy ≥ 3 months.
  Key Exclusion Criteria:
  1. Concurrent participation in another therapeutic clinical trial.
  2. Symptomatic CNS involvement.
  3. Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication.
  4. History of prolonged QTc interval.
  5. Known active infections (bacterial, fungal, viral including HIV positivity).
  6. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  7. Peripheral neuropathy ≥ Grade 2.
  8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded.

Relevance to patient case: possibly relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Summary: [Study Design] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.
  [Primary Objective] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy


Eligibility: [Inclusion Criteria]
  -  Provision of informed consent prior to any study specific procedures
  -  Men and women aged at least 18 years
  -  Small cell lung cancer harboring RICTOR amplification
  -  Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  -  Minimum life expectancy of 12 weeks
  -  Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  -  At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  -  No history of non-autologous bone marrow transplant.
  Exclusion Criteria:
  -  Participation in another clinical study with an investigational product during the last 21 days.
  -  Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
  -  Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
  -  Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
  -  Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
  -  Any haemopoietic growth factors within 14 days prior to receiving study treatment.
  -  Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
  -  Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Radiation Therapy and Chemotherapy in Treating Patients With Head and Neck Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combining mitomycin or porfiromycin with radiation therapy is more effective in treating patients with head and neck cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus either mitomycin or porfiromycin in treating patients with head and neck cancer.

Detailed description: OBJECTIVES: I. Compare the efficacy of mitomycin vs. porfiromycin as an adjunct to radiotherapy for the treatment of epidermoid carcinomas of the head and neck.
  OUTLINE: Randomized study. Arm I: Radiotherapy plus Single-Agent Chemotherapy. Irradiation of involved head and neck sites by external-beam radiotherapy (EBRT) alone (source not specified), brachytherapy alone (using permanent or removable radiation sources), or both; plus Mitomycin, MITO, NSC-26980. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Radiotherapy as in Arm I; plus Porfiromycin, NSC-56410.
  PROJECTED ACCRUAL: Approximately 200 patients will be entered over 3-4 years.

Eligibility: DISEASE CHARACTERISTICS: Biopsy-proven epidermoid carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasopharynx Unknown primary origin with positive head and neck nodes TNM Stages I-IV or recurrent disease with no distant metastases, i.e.: T1 N0 M0 T1 N1-3 M0 T2-4 any N M0 T0 N1-3 M0 No carcinoma of the true vocal cord or other condition with greater than 90% probability of cure
  PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: Not specified Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hct at least 25% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 2 mg/dl OR BUN less than 40 mg/dl Other: No other serious, life-threatening illness No second malignancy within 5 years except nonmelanomatous skin cancer outside the planned radiotherapy field
  PRIOR CONCURRENT THERAPY: At least 3 years since chemotherapy No prior radiotherapy to areas of current disease

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

Summary: RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.
  PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.

Detailed description: OBJECTIVES:
  -  Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositis/thrush in patients with head and neck cancer undergoing definitive radiotherapy.
  OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo standard hyperfractionated radiotherapy 5 days a week for 5-5.6 weeks. Patients receive oral fluconazole on days 1-4 and 28-31 of radiotherapy.
  -  Arm II: Patients undergo radiotherapy as in arm I. Patients who develop a microbiologically proven fungal infection or clinically evident oral cavity and/or oropharyngeal thrush may receive fluconazole as in arm I.
  PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven head and neck cancer undergoing definitive radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 21
  Performance status:
  -  Karnofsky 70-100%
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  SGOT and SGPT less than 2 times normal
  -  Alkaline phosphatase less than 2 times normal
  Renal:
  -  Not specified
  Other:
  -  No history of hypersensitivity to fluconazole
  -  HIV negative
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  At least 2 months since prior antifungal agents
  -  Not currently receiving phenytoin, hydrochlorothiazide, or warfarin
  -  If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Paclitaxel in Treating Patients With Advanced Head and Neck Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with recurrent or metastatic head and neck cancer.

Detailed description: OBJECTIVES: I. Evaluate the response rate and toxic effects of paclitaxel by 96 hour continuous infusion in chemotherapy naive and chemotherapy exposed patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
  OUTLINE: Patients receive paclitaxel as a 96 hour continuous IV infusion. Courses repeat every 3 weeks for a maximum of 12 courses. Patients with disease progression after 2 courses or with unacceptable toxicity at any time are removed from study.
  PROJECTED ACCRUAL: Approximately 109 patients will be accrued for this study over 4 years.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck (including nasopharynx) that is considered incurable with surgery or radiation therapy Bidimensionally measurable disease Patients whose only site of measurable disease is within a previous radiation port must have documented progressive disease or biopsy-proven recurrence after the completion of radiotherapy No uncontrolled CNS metastases
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No history of ventricular arrhythmias or symptomatic bradyarrhythmia Other: No significant detectable infection Not pregnant or nursing No other active malignancies Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interleukin-2, interferons, and monoclonal antibodies allowed Recovered from prior therapy Chemotherapy: Prior paclitaxel infusion no greater than 24 hours for recurrent or metastatic disease required Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered from any prior major surgery

Relevance to patient case: not relevant
Patient case: 64-year-old male with head and neck squamous cell carcinoma; genetic feature: CDKN2A

Clinical trial: Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck

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.
  PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.

Detailed description: OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma of the head and neck. II. Determine the toxicity profile of this combination treatment in these patients. III. Assess the response rate of treatment in these patients.
  OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3 patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are assessed for response every 2 weeks. Patients may continue treatment for up to 9 months or until disease progression.
  PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy Upper aerodigestive tract only Unresectable or recurrent disease following initial therapy with surgery and/or radiation Measurable or evaluable disease
  PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times institutional normal Transaminases no greater than 3 times institutional normal Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Adequate cardiac function No heart failure Pulmonary: Adequate pulmonary function not requiring supplemental oxygen Other: Not pregnant Fertile patients must use adequate contraception
  PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy allowed Surgery: Prior surgery allowed

Relevance to patient case: not relevant