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

Clinical trial: PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

Summary: The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer


Eligibility: Inclusion Criteria:
  -  Man or woman at least 18 years old
  -  Diagnosis of metastatic colorectal cancer
  -  At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  -  Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse Exclusion Criteria:
  -  History or known presence of central nervous system (CNS) metastases
  -  History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
  -  Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
  -  Prior oxaliplatin therapy
  -  Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
  -  Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as > Common terminology criteria (CTC) grade 2 [CTCAE version 3.0])
  -  Peripheral sensory neuropathy with functional impairment

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

Clinical trial: Efficacy and Safety of Everolimus in Patients With Metastatic Colorectal Cancer Who Have Failed Prior Targeted Therapy and Chemotherapy

Summary: To assess the safety and efficacy of weekly (70 mg per week) and daily (10 mg per day) everolimus in patients with metastatic colorectal cancer whose cancer has progressed despite prior treatment with targeted therapy and chemotherapy.


Eligibility: Inclusion criteria:
  -  Age ≥ 18 years old.
  -  Patients with metastatic colorectal cancer (CRC).
  -  Patients must have sufficient and obtainable tumor tissue for biomarker analysis from original surgical resection.
  -  Patients with documented disease progression within 6 months of their most recent dose of chemotherapeutic regimens.
  -  Patients with at least one measurable lesion.
  -  Adequate bone marrow function.
  -  Adequate liver function.
  -  Adequate renal function.
  -  Patients with a life expectancy of > 3 months.
  -  Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.
  -  Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment.
  -  Patients who give a written informed consent obtained according to local guidelines.
  Exclusion criteria:
  -  Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.
  -  Patients who have previously received RAD001.
  -  Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients.
  -  Chronic treatment with steroids or another immunosuppressive agent.
  -  Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.
  -  HIV seropositivity.
  -  Patients with an active, bleeding diathesis. Patients may use enoxaparin.
  -  Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
  -  Patients who have a history of another primary malignancy < 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
  -  Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
  -  Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to first study treatment.
  -  Patients unwilling to or unable to comply with the protocol.
  Other protocol defined inclusion/exclusion criteria may apply

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

Clinical trial: Panitumumab 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: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

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

Clinical trial: Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)

Summary: This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  ≥ 18 years of age
  -  Untreated non-small-cell lung cancer stage IIIB/IV
  -  Life expectancy > 3 months
  -  Performance status ECOG 0-2
  Exclusion Criteria:
  -  Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
  -  Any investigational agent(s) within 4 weeks prior to study entry
  -  Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
  -  Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

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

Clinical trial: OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.

Summary: This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility: Inclusion Criteria:
  -  adult patients, >=18 years of age;
  -  locally advanced or metastatic colorectal cancer;
  -  no previous treatment with chemotherapy for metastatic disease;
  -  at least one measurable lesion.
  Exclusion Criteria:
  -  radiotherapy to any site within 4 weeks before study;
  -  untreated brain metastases or primary brain tumors;
  -  clinically significant cardiovascular disease;
  -  chronic daily treatment with high dose aspirin (>325 mg/day);
  -  other co-existing malignancies or malignancies diagnosed within last 5 years.

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

Clinical trial: Registry for Patients With Acquired Resistance to Small Molecule Kinase Inhibitors in Non-Small-Cell Lung Cancer

Summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitors work in treating lung cancer. Some early studies have shown that gefitinib, erlotinib and similar drugs are more likely to work if a particular DNA change (also known as a mutation) is found in a protein that is important in lung cancer. This protein is called the epidermal growth factor receptor (EGFR). Since small molecule kinase inhibitors sometimes stop working, we would like to examine your tumor to learn why these medicines are not working as well. Your tumor will be examined for a variety of things including changes in the DNA of the EGFR. We will also sequence parts of the genes for HER2, HER3, HER4, and KRAS, other proteins thought to be important in lung cancer.

Detailed description: The goal of this protocol is to determine mechanisms of resistance to epidermal growth factor (EGFR) tyrosine kinase inhibitors (EGFR-TKI) in non-small cell lung cancer (NSCLC). A number of trials have shown small molecule kinase inhibitors to be active agents in the treatment of NSCLC [1]. Clinically these drugs have been noted to produce dramatic but infrequent responses. Mutations in the epidermal growth factor receptor have been shown to correlate with sensitivity to gefitinib and erlotinib[2,3]. However, we know that most patients who have initial responses to EGFR-TKI eventually progress. The mechanism of acquired clinical resistance to these inhibitors in patients incompletely understood.
  This is a protocol to study clinical characteristics and biopsy tissue of patients with non-small cell lung cancer who have had previous clinical response to small molecule kinase inhibitors and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of sensitivity and resistance to small molecule kinase inhibitors.

Eligibility: Inclusion Criteria:
  Patients diagnosed with unresectable or metastatic non-small cell lung cancer (NSCLC) and who fulfill the following eligibility criteria will be considered eligible for this study.
  -  Patient must have previously received treatment with small molecule kinase inhibitors targeting at least, in part, EGFR patients may have received other treatments since treatment with small molecule kinase inhibitors including radiation or chemotherapy)
  -  Development of disease progression while actively receiving tyrosine kinase inhibitor
  -  Signed informed consent
  Exclusion Criteria:
  -  None

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

Clinical trial: Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions

Summary: The purpose of this study is to investigate the response rate of cetuximab plus irinotecan every 2 weeks in patients harboring wild-type KRAS with and without detectable EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.

Detailed description: Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be accrued in this study. All patients should have wild-type KRAS.

Eligibility: Inclusion Criteria:
  -  Colorectal adenocarcinoma, Wild KRAS, 18-75 yr
  -  Estimated life expectancy of more than 3 months
  -  ECOG performance status of 0 to 1 at study entry
  -  Adequate bone marrow function
  -  Adequate liver function
  -  Documented progression during or within 3 months of irinotecan-containing regimens as a first-line chemotherapy
  -  Immunohistochemical evidence of a presence or absence of EGFR expression by PharmDx Kit
  -  Informed Consent
  Exclusion Criteria:
  -  Central nervous system (CNS) metastases or prior radiation for CNS metastases.
  -  Intestinal obstruction or impending intestinal obstruction due to peritoneal carcinomatosis
  -  Surgery (excluding biopsy for diagnosis) during 4 weeks prior to inclusion in the study.
  -  Evidence of gastrointestinal bleeding
  -  Exposure to Cetuximab
  -  Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment
  -  KRAS mutant Status
  -  Patients with serious toxicity to previous irinotecan-based chemotherapy
  -  Other serious illness or medical conditions

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

Clinical trial: A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

Summary: This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.


Eligibility: Inclusion Criteria:
  -  Histologically documented advanced cancer, Eastern Cooperative Oncology Group (ECOG) 0-1;
  -  Platelets > 100,000, ANC > 1500;
  -  Ccr > 60 or serum creat. <1.5
  -  Non-small cell cancer cohort:
  -  Eastern Cooperative Oncology Group (ECOG) 0-2, prior platin, < 4 prior chemotherapy regimen
  -  HgA1C <5.7%
  Exclusion Criteria:
  -  Active Central Nervous System (CNS) metastases;
  -  prior IGF1-R targeted therapy
  -  Any history of unstable angina, myocardial infarction or symptomatic congestive heart failure.

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

Clinical trial: A 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: 70-year-old male with non-small cell lung cancer; genetic feature: KRAS (G12C)

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