araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

Summary: The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

Detailed description: Epidermal growth factor receptor(EGFR) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. EGFR tyrosine kinase inhibitor(TKI), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with EGFR gene mutation. In addition, monoclonal antibodies to EGFR, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer.
  The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80%. Clinical features include acneform folliculitis, xerosis, paronychia, and itching. Of these, about 10% of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results.
  There have been many attempts to prevent or treat such skin toxicity. However, there has been no scientifically proven treatment until now.
  There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors, as a result of studies that improve acne significantly compared to placebo.
  The purpose of this study is to evaluate the therapeutic efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).

Eligibility: Inclusion Criteria:
  -  Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
  -  Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
  -  Patients who can understand and follow the protocol
  -  Patients who spontaneously agreed to the study
  Exclusion Criteria:
  -  NCI-CTCAE grade 4 patients requiring systemic drug therapy
  -  Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
  -  Patients with existing acne history
  -  Patients who have already received anti-EGFR therapy

Relevance to patient case: not relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

Summary: A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Detailed description: A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  1) Stage IV or recurrent non-Small cell lung cancer
  -  2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  -  3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
  Exclusion Criteria:
  -  1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
  -  2) Active, known or suspected autoimmune disease or HIV infection
  -  3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
  -  4) Untreated Central Nervous System metastases
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: A Study Comparing Pemetrexed Plus Cisplatin Versus Pemetrexed Alone in NSCLC Patients Who Have Progressed on First Line EGFR-TKI

Summary: It has not been established whether platinum-based doublets is better than single agent chemotherapy in EGFR mutant NSCLC patients who failed first-line EGFR TKI.
  In this prospective trial, the investigators try to evaluate whether the progression-free survival of pemetrexed/cisplatin (PC) regimen is longer than that of pemetrexed single(P) regimen in NSCLC patients who have progressed after first line treatment of EGFR-TKI.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed nonsquamous NSCLC with activating EGFR mutation (on exon 19 deletion or exon 21 L858R mutation)
  -  Stage IIIb, IV or recurrent NSCLC (AJCC 7th criteria)
  -  Age ≥ 20 years
  -  ECOG performance status of 0 or 1
  -  At least one measurable lesion by RECIST 1.1
  -  Progression after first line treatment with EGFR TKIs for advanced NSCLC
  -  Asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
  -  At least 2 weeks later after whole brain radiotherapy or palliative radiotherapy
  -  Adequate renal function: estimated creatinine clearance ≥ 45 mL/min
  -  Organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 3 UNL, in case of known hepatic metastasis, AST/ALT< 5 UNL
  -  Written informed consent form
  -  No other previous systemic chemotherapy
  Exclusion Criteria:
  -  Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
  -  Patients with post-obstructive pneumonia or uncontrolled serious infection
  -  Pregnant or nursing women (Women of reproductive potential have to agree to use an effective contraceptive method)
  -  Uncontrolled symptomatic brain metastasis
  -  Presence of third space fluid which cannot be controlled by drainage
  -  Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

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: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Bone Metastasis on the Survival of Gefitinib Effective Patients

Summary: Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Detailed description: The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Eligibility: Inclusion Criteria:
  1. histological and (or) cytological diagnosed NSCLC patients.
  2. patient was effective in Gefitinib treatment more than 6 months.
  3. whether patient received chemotherapy and other treatment is not restricted.
  4. whether patient was detected for EGFR gene mutation was not restricted.
  Exclusion Criteria:
  1. patient with small cell lung cancer.
  2. patient without cytology or histopathology diagnosis results.
  3. patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
  4. patient with poor treatment compliance.
  5. patient with incomplete data.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Detailed description: Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

Eligibility: Inclusion Criteria:
  For inclusion in the study, patients should fulfill the following criteria:
  1. Aged at least 18 years.
  2. Histologically or cytologically documented Stage IV NSCLC.
  3. Confirmed tumor PD-L1 status prior to randomization.
  4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.
  5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
  6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.
  Exclusion Criteria:
  Patients should not enter the study if any of the following exclusion criteria are fulfilled:
  1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
  2. Active or prior documented autoimmune or inflammatory disorders.
  3. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
  4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC

Summary: This is an open-label multicenter 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC.
  Arm A: mRNA Vaccine [BI 1361849 (formerly CV9202)] + anti-PD-L1 [durvalumab] Arm B: mRNA Vaccine [BI 1361849] + anti-PD-L1 [durvalumab] + anti-CTLA-4 [tremelimumab]
  For each arm of the study, there is a dose evaluation phase in which the Recommended Combination Dose (RCD) is determined according to a standard 3 + 3 design. The dose evaluation phase is followed by an expansion phase, in which the cohort at the RCD is expanded to 20 subjects (inclusive of the subjects from the dose evaluation cohort).


Eligibility: Inclusion Criteria
  1. Histologic confirmation of metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1 mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of anti-PD-1/PD-L1 therapy. Subjects who received prior anti-PD-1/PD-L1 therapy must have progressed during or after treatment, but not prior to Week 12 of treatment.
  2. Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment biopsy.
  3. Subjects with treated brain metastases must have been treated with surgery and/or radiation therapy ≥ 21 days pre-study and must be clinically stable with no requirement for steroids.
  4. Laboratory parameters for vital functions should be in the normal range.
  5. ECOG Performance Status ≤ 2.
  Exclusion Criteria
  Subjects may not enter the study if they fulfill any of the following criteria:
  1. Treatment with an investigational agent within 4 weeks of starting treatment or prior treatment with anti-CTLA-4 therapy.
  2. Active, suspected or prior documented autoimmune disease, clinically significant cardiovascular disease, or clinically uncontrolled hypertension.
  3. History of pneumonitis or interstitial lung disease, or any unresolved immune-related adverse events following prior therapy.
  4. Major surgery within 4 weeks of starting treatment (or scheduled for surgery during the projected course of the study) or prior cancer vaccine treatment or allogeneic bone marrow transplantation.
  5. Subjects who are immunosuppressed, including those with known immunodeficiency or have active infection including tuberculosis or other serious illnesses.
  6. Skin disease (e.g., psoriasis) that may prevent intradermal administration of the vaccine into the target areas.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Frequency of EGFR and KRAS Mutations and Clinical-prognostic Correlation in Brazilian Lung Cancer Patients

Summary: The assessment of the type and frequency of EGFR and KRAS mutations in lung cancer patients, as well as clinical-prognostic correlation, are crucial in the era of targeted therapies. EGFR-activating mutations predict responsiveness to EGFR tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients and KRAS analysis will be useful in a near future for newest target drugs. In Brazil, few data about the prevalence of EGFR and KRAS mutations is available and their knowledge would allow optimize personalized medicine.

Detailed description: Assessment of the types and frequency of EGFR and KRAS mutations in NSCLC, as well clinical-prognostic correlations has been extensively studied in many populations. Few Brazilian studies evaluating mutational status in NSCLC has been done so far, none of then explored the regional background nor have considered the quantitative analysis of mutant cell in each sample. Quantitative analysis of the tumor maybe relevant for treatment design for positive samples, p.e a tumor with 90% of mutant clones versus a 15% of mutant clones, which can be obtained currently by the method of pyrosequencing. In this study, investigators will assess EGFR and KRAS status through the pyrosequencing quantitative technique, and will also correlate these with clinical-pathological variables among both adenocarcinoma and squamous cell histological subtypes. So far, no study that have made this correlation is available.

Eligibility: Inclusion Criteria:
  -  Brazilian patients with metastatic non-small cell lung cancer.
  Exclusion Criteria:
  -  Small cell lung cancer and non-metastatic patients.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

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: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Lung Cancer Registry for Lung Cancer Patients

Summary: In the light of a new era in the management of lung cancer this non-interventional study intend to capture all the epidemiological, clinical, pathological, molecular and treatment parameters of non-small cell (NSCLC) and small cell (SCLC) lung cancer patients from a tertiary Oncology Clinic in an Electronic Data Base (EDB).

Detailed description: Investigators intend to build an electronic database which will record the epidemiological, clinical, pathological, molecular data and treatment parameters of lung cancer patients (NSCLC and SCLC) who are referred to a tertiary Oncology Clinic. Documentation will include: a) Patient demographics, co- morbidities, tobacco exposure in pack-years, b) Disease related parameters: method of diagnosis, histological type, disease staging (according to 7th edition of TNM for lung cancer) and metastatic sites if any, c) Molecular status: mutation status for Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS, Hepatocyte Growth Factor Receptor (HGFRor cMET), Human Epidermal Growth Factor Receptor 2 (HER2), proto-oncogene B-Raf, and Programmed-Death Ligand 1 (PD-L1) testing when available, d) Type of treatment (surgery, radiotherapy, chemotherapy, targeted therapies, immune-therapy), and Line of treatment (neo-adjuvant, adjuvant, 1st, 2nd, 3rd, palliation therapy), e) Clinical outcome: Overall Survival (OS), Response Rate (RR), and Progression Free Survival (PFS).

Eligibility: Inclusion Criteria:
  - Since this will be a non-interventional study all adult patients who will be consent for registration of their data to EDB will be enrolled.
  Exclusion Criteria:
  -  Patients with insufficient epidemiological or clinical data will be excluded such as patients with no demographic data or patients that have not taken at least 2 cycles of therapy.

Relevance to patient case: possibly relevant
Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Treatment of Non-small Cell Lung Cancer With Cytokine-induced Killer (CIK) Cells Blocked by PD-1 Antibody

Summary: to evaluate the prognosis of non-small cell lung carcinoma patients under CIK cellular treatment with PD-1 blocking on top of the standard therapy


Eligibility: Inclusion Criteria:
  -  non-small cell lung cancer;
  -  more than 50% tumor tissues positive with PD-L1;
  -  EGFR and ALK wild type
  -  no other tumors
  Exclusion Criteria:
  -  with systematic diseases shortening survival

Relevance to patient case: possibly relevant