araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Summary: This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib

Detailed description: Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.

Eligibility: Inclusion Criteria:
  -  Ineligibility for participation in any ongoing clinical study of the investigational product
  -  Age ≥18 years
  -  Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
  -  For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
  -  For ROS1 positive patients: failure to prior treatment with at least crizotinib
  -  Adequate bone marrow, liver, renal, pancreatic functions
  -  Negative pregnancy test at screening
  Exclusion Criteria:
  -  Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
  -  History of interstitial fibrosis or interstitial lung disease
  -  Concomitant use of prohibited medication
  -  Clinically significant cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR >220 msec
  -  Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc >470 msec, or congenital long QT syndrome
  -  History of or predisposing characteristics for acute pancreatitis

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

Summary: Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed description: The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Eligibility: Inclusion Criteria:
  1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
  2. Age of 18 years or older.
  3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
  4. Participants must have hemoglobin > 10 mg/dL.
  5. Ability to understand and willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hepatitis (all types) in patient's medical record
  2. HIV documented in patient's medical record
  3. Hemoglobin < 10 mg/dL
  4. Less than 18 years of age
  5. Histologically confirmed NSCLC Stage I-IIIA
  6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Study of Oral cMET Inhibitor INC280 in Chinese Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (NSCLC)

Summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult Chinese patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.


Eligibility: Inclusion Criteria:
  -  Stage IIIB or IV NSCLC (any histology) at the time of study entry
  -  Histologically or cytologically confirmed diagnosis of NSCLC that is:
  1. EGFR wt as per patient standard of care by a validated test
  2. AND ALK-negative rearrangement as part of the patient standard of care by a validated test
  3. AND (by central assessment) either:
  -  Cohort 1: Pre-treated patients with cMET GCN ≥ 6 or
  -  Cohort 2: Pre-treated patients with cMET GCN ≥4 and < 6, or
  -  Cohort 3: Pre-treated patients with cMET mutations regardless of cMET GCN, or
  -  Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease
  -  At least one measurable lesion as defined by RECIST 1.1
  -  Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
  -  Patients must have adequate organ function
  -  ECOG performance status (PS) of 0 or 1
  Details and other protocol-defined inclusion criteria may apply
  Exclusion Criteria:
  -  Prior treatment with crizotinib, or any other cMET or HGF inhibitor
  -  Patients with characterized EGFR mutations that predict sensitivity to EGFR therapy, including, but not limited to exon 19 deletions and exon 21 mutations
  -  Patients with characterized ALK-positive rearrangement
  -  Clinically significant, uncontrolled heart diseases.
  -  Patients receiving treatment with medications that cannot be discontinued at least 1 week prior to first INC280 treatment and for the duration of the study:
  -  Strong and moderate inhibitors of CYP3A4
  -  Strong inducers of CYP3A4
  -  Impairment of GI function or GI disease that may significantly alter the absorption of INC280
  -  Patients receiving treatment with any enzyme-inducing anticonvulsant
  -  Previous anti-cancer and investigational agents within 4 weeks or ≤ 5 x half-life of the agent (whichever is longer) before first dose
  -  Pregnant or nursing women
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception
  -  Sexually active males unless they use a condom during intercourse
  Other protocol-defined exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer

Summary: The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

Detailed description: At study start, only Cohort A is active.
  If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program.
  The sponsor will inform the investigators if, and when, Cohort B and C are active.

Eligibility: Inclusion Criteria:
  -  Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
  -  Has received at least 2 prior regimens of standard treatment
  -  Has measurable disease assessed by the investigator based on RECIST version 1.1.
  -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1
  Exclusion Criteria:
  -  Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
  -  Has a medical history of clinically significant lung disease
  -  Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

Summary: This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in subjects with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Subjects with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., subjects with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.


Eligibility: Inclusion Criteria:
  1. Male or female, aged 18-75 years on the day of signing informed consent.
  2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
  Note: Subjects with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
  3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
  4. Subjects must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded [FFPE] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
  Exclusion Criteria:
  1. Subjects with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for subjects with non- squamous NSCLC). Subjects with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
  2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
  3. Prior therapies targeting PD-1, PD-L1 or PD-L2

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Lung Cancer Next Generation Sequencing Using the Oncomine Comprehensive Assay

Summary: Currently, publicly funded standard of care testing in Ontario for stage IV lung cancer patients uses individual gene tests to look for mutations in the EGFR and ALK genes. This testing broadens treatment options for patients, however there are other gene mutations with corresponding targeted treatments that are not routinely tested for. This study will evaluate the utility and added value of using a next generation sequencing (NGS) panel, the Oncomine Comprehensive Assay v3, to profile stage IV lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years of age
  -  Pathologic or cytologic confirmation of lung adenocarcinoma (mixed adenocarcinoma and sarcomatoid features permitted)
  -  Stage IV disease
  -  Sufficient FFPE tumour tissue for OCCP testing
  -  Performance status 0-2
  -  Candidates for targeted therapy (TKIs) and/or clinical trials as determined by the patient's medical oncologist
  -  Prognosis > 6 months
  -  Known translocations of RET, MET exon14 skipping variants, or MET amplification are allowed
  Exclusion Criteria:
  ● Patients with known EGFR, KRAS, BRAF and ERBB2 mutations or ALK or ROS1 fusions at study entry unless acquired resistance to molecularly targeted therapy

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Noninvasive vs. Invasive Lung Evaluation

Summary: Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Patients with NSCLC, which is: (1) Biopsy-proven (confirmatory biopsy must have been collected within 12 months prior to enrollment), (2) Metastatic (Stage IV, Stage IIIB when curative intent is not an option, or relapsed/recurrent disease after original diagnosis of Stage I-IIIA), (3) Non-squamous histology (mixed squamous and adenocarcinoma is allowed), (4) No prior treatment for advanced stage NSCLC: (a) Resection of or radiation to a single metastatic site is allowed if there are other untreated and measurable sites of metastatic disease at the time of enrollment. (b) Patients who have previously undergone surgical resection or radiation for Stage I-IIIA NSCLC are eligible if primary treatment was completed at least 6 months prior to the development of metastatic disease; for patients who received adjuvant systemic therapy, the last dose of treatment must be given at least 6 weeks prior to enrollment.
  -  Age ≥ 18 years
  -  Ability to understand a written informed consent document, and the willingness to sign it.
  -  Willingness to provide blood sample at the time points of pre-treatment, approximately 2 weeks after initiation of systemic treatment, and end of study).
  -  Patient has or will have standard-of-care tissue genotyping ordered. If the physician intends to order tissue genotyping, but there is insufficient material for analysis, the patient is still eligible for enrollment.
  Exclusion Criteria:
  -  Pregnancy
  -  Any other concurrent malignancy except for localized, non-melanoma, cutaneous cancer or non-invasive cervical cancer. Any prior cancer other than NSCLC must have occurred more than 2 years prior to study entry with no evidence of currently active disease.
  -  Prior treatment for metastatic NSCLC including but not limited to: (1) Systemic treatment (targeted therapy, chemotherapy, immunotherapy, biologic therapy, etc.), (2) Resection of a metastatic lesion if the resected metastasis had been the only site of measurable metastatic disease, or resection of more than one metastatic lesion, (3) Radiation of a metastatic lesion or resection bed if given to the only measurable site of metastatic disease, or radiation to more than one metastatic lesion.

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Effect of Chemotherapy on TMB in NSCLC

Summary: Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
  -  Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
  -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
  Exclusion Criteria:
  -  Patient can not comply with research program requirements or follow-up;
  -  Patient will receive immunotherapy;

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: Effect of Chemotherapy on PD-L1 in NSCLC

Summary: PD-L1 is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect PD-L1 in advanced NSCLC patients. The present study aims to evaluate whether PD-L1 will change after receiving chemotherapy in advanced NSCLC patients.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
  -  Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
  -  ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min
  Exclusion Criteria:
  -  Patient can not comply with research program requirements or follow-up;
  -  Patient will receive immunotherapy;

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: FIVC in Advanced Colorectal Cancer Patients With BRAF V600E Mutation.

Summary: This clinical trial aims to evaluate the efficacy, safety of FOLFIRI with vemurafenib and cetuximab in Advanced Colorectal Cancer Patients with BRAF V600E mutation.


Eligibility: Inclusion Criteria:
  -  Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence;
  -  Patients with BRAF V600E mutation and extended RAS wild type;
  -  Patients have measurable lesions;
  -  Patients are not available for targeted therapy or patients refuse to receive targeted therapy;
  -  Age should be 18-25 years;
  -  Performance status should be 0-2;
  Exclusion Criteria:
  -  Patients with RAS mutation type;
  -  Patients with brain metastases;
  -  Patients could not tolerate chemotherapy;
  -  Patients have secondary primary tumor

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib

Summary: The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Advanced biopsy-proven metastatic non-small cell lung cancer
  -  Somatic activating mutation in EGFR in a tumor biopsy
  -  Prior treatment with osimertinib with response followed by disease progression
  -  No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
  -  Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy after disease progression on osimertinib prior to study initiation
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  Karnofsky performance status (KPS) >/= 70%
  -  Age >/= 18 years old
  -  Ability to swallow oral medication
  -  Adequate organ function
  -  AST, ALT </= 3 x ULN
  -  Total bilirubin </= 1.5x ULN
  -  Creatinine </= 1.5x ULN OR calculated creatinine clearance >/= 60ml/min
  -  Absolute neutrophil count (ANC) >/= 1000 cells/mm3
  -  Hemoglobin>/=8.0 g/dL
  -  Platelets >/=75,000/mm3
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Any radiotherapy within 1 week of starting treatment on protocol.
  -  Any major surgery within 1 weeks of starting treatment on protocol.
  -  Any evidence of active clinically significant interstitial lung disease
  -  Continue to have unresolved > grade 1 toxicity from any previous treatment Treatment
  -  Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
  -  Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids

Relevance to patient case: not relevant
Patient case: 54-year-old female with lung adenocarcinoma; genetic feature: SND1-BRAF fusion

Clinical trial: A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Summary: This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.


Eligibility: Inclusion Criteria:
  1. BRAF V600 mutation in solid tumor.
  2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.
  3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment.
  4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment.
  5. ECOG performance status of 0-1.
  6. Life expectancy ≥ 3 months.
  7. Ability to take the medicine orally.
  8. Ability to understand and the willingness to sign a written informed consent document.
  Exclusion Criteria:
  1. Hypersensitivity to study drug ingredients or their analogues.
  2. Prior therapy with MEK-inhibitor.
  3. Receiving any other anti-cancer therapy at the same time .
  4. Active central nervous system (CNS) lesion.
  5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.
  6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；
  7. Uncontrolled concomitant diseases or infectious diseases.
  8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).
  9. History of HIV,HCV,HBV infection.
  10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.
  11. Serum HCG test is positive.
  12. Other conditions that increase the risk of study and influence the result.

Relevance to patient case: possibly relevant