araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Summary: This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced/metastatic non-small cell lung cancer
  -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
  Exclusion Criteria:
  -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
  -  History of or known brain metastases

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Summary: The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.


Eligibility: Inclusion Criteria:
  -  Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
  -  WHO Performance Status 0-2
  -  No prior chemotherapy, biological or immunological therapy/surgery
  Exclusion Criteria:
  -  Any evidence of clinically active interstitial lung disease
  -  Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
  -  Patients with previously diagnosed and treated CNS metastases or spinal cord compression

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

Summary: The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.


Eligibility: Inclusion Criteria:
  -  Diagnosis of metastatic adenocarcinoma of the colon or rectum
  -  Available paraffin-embedded tumor tissue
  -  Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
  -  Measurable disease
  -  Adequate hematologic, renal, hepatic and metabolic function
  Exclusion Criteria:
  -  Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
  -  Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
  -  Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
  -  CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
  -  Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
  -  Clinically significant cardiovascular disease
  -  History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
  -  Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
  -  Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
  -  Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
  -  Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
  -  Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Panitumumab Plus FOLFIRI in First-line Treatment of Metastatic Colorectal Cancer

Summary: To estimate the effect of KRAS mutation status (Wild-type versus Mutant) on objective response rate and other measures of efficacy for patients treated with panitumumab in combination with a chemotherapy regimen of irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as first-line therapy for metastatic colorectal cancer (mCRC).


Eligibility: Inclusion Criteria:
  -  Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
  -  Measurable disease according to modified RECIST guidelines.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  -  Paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour available for central lab analysis.
  -  Adequate haematologic, renal, hepatic and metabolic function.
  Exclusion Criteria:
  -  Central nervous system metastases.
  -  Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.
  -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
  -  Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.
  -  Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.
  -  History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest computed tomography (CT scan.
  -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
  -  History of Gilbert's syndrome or dihydropyrimidine deficiency.
  -  Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.
  -  Any investigational agent within 30 days before initiation of study treatment.
  -  Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.
  -  Subject who is pregnant or breast-feeding.
  -  Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the course of the study and for six months after the last study drug administration for women, and one month for men.
  -  Other protocol specified criteria and specific details may apply.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Study of Salirasib to Treat Non-Small Cell Lung Cancer

Summary: The purpose of this study is to determine whether Salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.


Eligibility: Inclusion Criteria:
  -  Age 18 or older
  -  Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
  -  Measurable disease
  -  Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent disease and documented KRAS mutation
  -  Last dose of radiotherapy > 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy
  -  No history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
  -  Karnofsky Performance status of 70 or greater
  -  Body Weight > 50 kg
  -  Life expectancy ≥ 3 months
  -  Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN, alkaline phosphatase ≤ 5x ULN, WBC > 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dL.
  -  No coexisting cardiac or medical problems that would limit compliance in the study
  -  Willing to undergo blood sampling for pharmacokinetic analysis
  -  Negative pregnancy test, if applicable
  Exclusion Criteria:
  -  Evidence of active heart disease including myocardial infarction within previous 3 months
  -  Active infectious process
  -  Active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions)
  -  Pregnant or lactating
  -  Major surgery without full recovery or major surgery within 3 weeks prior to treatment start
  -  QTc Interval > 470 msec
  -  Gastrointestinal tract disease resulting in inability to take or absorb oral medications

Relevance to patient case: definitely relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

Summary: To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.


Eligibility: Inclusion Criteria:
  -  Advanced Non-Small Cell Lung Cancer (NSCLC)
  -  Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
  -  Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
  -  Measurable disease .
  -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  -  Tissue available for KRAS/ EGFR testing
  -  Creatinine clearance > 40 cc/min or serum creat < 1.5 x ULN
  Exclusion Criteria:
  -  Chemotherapy
  -  Radiotherapy
  -  Biological or investigational agents within 4 weeks of baseline disease assessment.
  -  Patients who lack of tolerance of erlotinib therapy.

Relevance to patient case: definitely relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Summary: This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.


Eligibility: Inclusion Criteria:
  -  advanced measurable Non-Small Cell Lung Cancer (NSCLC);
  -  progressed after 1-2 prior chemotherapy;
  -  Eastern Cooperative Oncology Group (ECOG) 0-2;
  -  tissue available for future KRAS/ EGFR testing
  Exclusion Criteria:
  -  prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
  -  active or untreated Central Nervous System (CNS) metastases;

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

Summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  -  Mutant-type KRAS tumor at screening
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  -  Adequate hematology, renal, hepatic, and coagulation function
  Exclusion Criteria:
  -  History or known presence of central nervous system metastases
  -  History of other malignancy
  -  Prior irinotecan-based chemotherapy for advanced/metastatic disease
  -  Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  -  Uncontrolled cardiovascular disease

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)

Summary: This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

Detailed description: Allocation and Arms Additional Information: All Patients will receive an 8-week
  open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)
  Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Eligibility: Inclusion Criteria:
  -  Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
  -  Patient has a documented mutation of the KRAS gene
  -  Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
  -  A minimum of 4 weeks has passed since the most recent anti-cancer treatment
  -  Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
  -  Patient has adequate organ function
  -  Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
  -  Patient is >=18 years of age
  Exclusion Criteria:
  -  Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
  -  Patient is known to have active brain metastases
  -  Patient is currently participating or has participated in an investigational drug study within 30 days
  -  Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
  -  Patient has an active infection requiring prescribed intervention
  -  Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer

Summary: RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.

Detailed description: OBJECTIVES:
  -  To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer.
  -  To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity.
  -  To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents.
  OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment [by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis.
  After completion of study, patients will be followed until their death.

Eligibility: Inclusion criteria
  -  Diagnosis of suspected lung cancer or lung cancer
  Exclusion criteria
  -  Inability to undergo therapy

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

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

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

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

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

Relevance to patient case: possibly relevant