Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Amino Acids

Mitogens

Tyrosine Kinase Inhibitors

Dacomitinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.

Daniel Tan, BSc, MBBS, PhD

This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC).

National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.

Phase 2 Study of Dacomitinib in NSCLC

A Single-arm, Open-label, Phase 2 Study of Dacomitinib With or Without Dose Titration for the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Subjects With an Epidermal Growth Factor Receptor (EGFR) Activation Mutation

Percentage of subjects with PFS at 12 months

Proportion of subjects with a best overall response of either complete response (CR) or partial response (PR)

Proportion of subjects with a best overall response of either CR or PR of intracranial disease

Pfizer

National Cancer Centre, Singapore

Lazertinib

Patients who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period

Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period

Platinum-based Chemotherapy

This retrospective, external comparator study for Lazertinib aims to assess the real-world effectiveness of Lazertinib as the second-line treatment versus platinum-based chemotherapy in patients with epidermal growth receptor sensitizing mutation-positive, locally advanced or metastatic Non-small Lung cancer.

Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC

Retrospective, External Comparator Study to Assess the Real-World Effectiveness of Lazertinib as the Second-Line Treatment Versus Platinum-based Chemotherapy in Patients With EGFR Mutation+ Locally Advanced or Metastatic NSCLC

(rw) PFS, is defined as the time from the first administrating date of treatment (Lazertinib or Platinum-based Chemotherapy) to clinician-assessed progression disease or death from any cause, whichever occurs first.

(rw) OS, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to death.

(rw) ORR, is defined as the proportion of patients with the response of Complete Response (CR) or Partial Response (PR) during the follow-up period.

(rw) TTD, is defined as the time from the first administrating date of treatment(Lazertinib or Platinum-based Chemotherapy) to treatment discontinuation.

Yuhan Corporation

All eligible patients who meet all inclusion criteria and none of the exclusion criteria

This is a non interventional, observational, retrospective study including patients with EGFR-mutated advanced NSCLC, treated with 1st or 2nd generation EGFR TKI therapy in first line

Non Interventional

Konstantinos Syrigos, Prof.

Multinational, multi-center medical record review to describe the treatment patterns, clinical outcomes, and EGFR / T790M testing practices in EGFR-mutated advanced NSCLC patients receiving first-line EGFR TKI therapy in Europe.

The aim is to generate real-life data on treatment patterns of the EGFR-mutated advanced NSCLC patients receiving first- or second-generation EGFR TKI in first line of therapy as provided per routine practice in eight countries. An approximate number of 820 patients will take part in the REFLECT study.

It is anticipated that data, generated from the proposed large cohort across centers in Europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.

Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)

Real World Treatment Patterns, Clinical Outcomes and EGFR / T790M Testing Practices in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Receiving First-Line TKI Therapy

Frequency distribution of first-line EGFR TKI of first- or second generation prescribed: erlotinib, gefitinib, or afatinib

Proportion of patients with a progression event during first-line EGFR TKI therapy or other evidence recorded in the patient's medical records deemed by the clinician to be indicative of progression; Time to progression, defined as time from EGFR TKI therapy initiation in the first-line locally advanced or metastatic setting until the earliest of progression death, or end of available follow-up (i.e., progression-free survival); Proportion of patients discontinuing first-line EGFR therapy for reasons other than progression event or death

Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up; Frequency distribution of the second-line therapy regimen (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy) among patients initiating second-line therapy.

Patients' demographics, including: sex (male/female), and age at EGFR TKI initiation.

Baseline disease characteristics, including:

Smoking status at initial NSCLC diagnosis, Tumor histology and disease stage at initial NSCLC diagnosis, Eastern Cooperative Oncology Group (ECOG) performance status at initial NSCLC diagnosis and at EGFR TKI initiation, Treatment history: for patients initially diagnosed at earlier-stage disease, cancer-directed and palliative therapies received before first diagnosis of or progression to advanced/metastatic EGFR-mutated NSCLC.

Molecular testing patterns, including: type of sample/test used to assess the EGFR mutation, for example: primary/secondary tumor, tissue/cytology or blood sample; Molecular testing results: EGFR mutation type (exon 19 deletion, L858R mutation, other).

Incidence and time to development of BM from first diagnosis of locally advanced or metastatic NSCLC, including:

Proportion of patients with BM since diagnostic of metastatic disease and proportion of patients with BM developed during treatment, Type of test used to confirm BM diagnosis (e.g., tissue biopsy, imaging, spinal tap, neurologic exam), Proportion of patients who have BM at start of first-line EGFR TKI therapy. Proportion of patients with no development of BM, Patients' demographic and clinical characteristics associated with development of BM, Incidence of BM and time to development of BM from start of first-line EGFR TKI therapy, Proportion of patients prescribed treatments for BM and type of therapy Overall survival (in months) measured from first diagnosis of BM to the date of death from any cause, with patients last known to be alive censored at the date of last available follow-up.

Incidence and time to development of LM disease from first diagnosis of locally advanced or metastatic NSCLC, including:

Proportion of patients with LM at first diagnosis of metastatic disease, Type of test to confirm LM diagnosis (cerebrospinal fluid cytology, tissue, imaging, etc.), Proportion of patients who have LM at start of first-line EGFR TKI therapy, Proportion of patients who later develop (during treatment) LM, Proportion of patients with no development of LM, Incidence of LM and time to development of LM from start of first-line EGFR TKI therapy.

Overall survival (in months) measured from first diagnosis of LM disease to the date of death from any cause, with patients last known to be alive censored at the date of last available follow-up.

Proportion of patients prescribed other systemic treatments (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy) in combination with first-line EGFR TKI therapy.

Proportion of patients tested for T790M mutation and among those tested, the proportion who were positive for the mutation, including:

Binary distribution of T790M mutation testing and, among those tested, the proportion with a positive result, Type of test used to assess the T790M mutation (tissue/cytology or blood sample).

Among patients tested and positive for T790M mutation, what proportion receives treatment with osimertinib - applicable study measures include binary distribution of osimertinib treatment initiation, and requency distribution of the line of therapy (second- or later-line in the metastatic setting) in which osimertinib was initiated.

Among patients progressing on first-line EGFR TKI therapy and tested for T790M, proportion who receive (or not) second-line therapy and the second-line therapy selection (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy), including:

Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up, Among patients initiating second-line therapy, frequency distribution of the second-line therapy regimen observed (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy).

Among patients progressing on first-line EGFR TKI therapy and not tested for T790M, proportion who receive (or not) second-line therapy and the second-line therapy selection (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy), including:

Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up, Among patients initiating second-line therapy, frequency distribution of the second-line therapy regimen observed (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy).

Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up among patients tested and not tested for T790M mutation.

Proportion of patients prescribed third- or later lines of therapy and type of therapies selected (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy), and how these proportion varies by the second-line therapy category received.

OS (in months) measured overall from first diagnosis of or progression to locally advanced or metastatic disease, OS from start of first-line EGFR TKI therapy to the date of death from any cause, with patients last known to be alive censored at the date of last available follow-up.

Proportion of patients with other positive mutations, in case additional molecular testing were performed at the time of initial EGFR testing or at the time of T790M testing (e.g., KRAS, BRAF, ROS1 translocation, PD-L1 expression, MET amplification, ALK rearrangement, RET rearrangement, HER2 exon 20 insertion, TP53, others).

AstraZeneca

Antineoplastic Agents

Gefitinib

180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD

180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD

BPI-7711

Placebo Tablet

Placebo capsule

Yuankai Shi

A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

This is a Phase III clinical study, which aims to compare the efficacy and safety of BPI-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with EGFR mutation.

A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

A Randomized, Double-blind, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of BPI-7711 Capsule in Locally Advanced or Recurrent/Metastatic Treatment-naïve Non-small Cell Lung Cancer Patients With EGFR Mutation

Progression-free survival evaluated by Blinded Independent Center Review

Progression-free survival evaluated by investigators

Beta Pharma Shanghai

Adenocarcinoma

Neoplastic Cells, Circulating

Blood samples every 3 months till disease progression or intolerable due to side effect.

Chao-Chi Ho

Correlation of epithelial growth factor receptor mutation in blood of lung cancer patient and clinical outcome.

EGFR tyrosine kinase mutation is frequently seen in our NSCLC, especially adenocarcinoma.1 The epidermal growth factor receptor (EGFR) of receptor tyrosine kinases (TKs) regulate many developmental, metabolic and physiological processes. In tumor cells, the TK activity of EGFR may be dysregulated by several mechanisms, including EGFR gene mutation, increased gene copy number and EGFR protein overexpression.1 Improper activation of EGFR TK results in increased malignant cell survival, proliferation, invasion and metastasis. EGFR overexpression is observed in tumors from more than 60% of patients with metastatic non-small-cell lung cancer (NSCLC) and is correlated with poor prognosis.2 Treatment with the reversible EGFR TK inhibitors (TKIs), gefitinib and erlotinib, results in dramatic antitumor activity in a subset of patients with NSCLC. Sequencing of the EGFR gene revealed that a majority of tumors responding to EGFR TKIs harbored mutations in the TK domain of EGFR. For patients whose tumors exhibit EGFR mutations, the response rate to gefitinib and erlotinib is approximately 75%, suggesting that these mutations, at least in part, drive malignant transformation.

However, the disease-free time to progression was still less than 1 year in most study.3-5 More than half of patients acquired resistant by new EGFR T790M resistance mutation. A second biopsy at the time of progression is becoming an issue. However, Only around 30% of NSCLC patients can receive gene testing to predict target therapy response because of the risk and difficulty in obtaining adequate tissues from the primary lung tumors by biopsy. Serial monitoring the emergence of resistant mutations is almost not possible. Recently, circulating free DNAs (cfDNAs) become a promising topic in cancer research. cfDNA can be used as a liquid biopsy, allowing repeated blood samples to be taken and changes in mutation status to be tracked throughout a cancer treatment, paving the way for a potential use in following up of treatment response, gauging prognosis, or monitoring of recurrence.6 It has been known for over a hundred years that disseminated tumor cells can be found in the circulation of patients with metastatic cancer and it has been hypothesized that these circulating tumor cells (CTCs) may represent cancer stem cells or a high metastatic potential cellular population.7 The major challenge since as few as one CTC may be found in the background of 105-106 peripheral blood mononuclear cells.8 CTCs are an attractive alternative to tumor tissue for biomarker analysis including EGFR mutation. CTCs can be obtained from a routine blood draw with minimal risk and inconvenience to the patient compared to a fresh biopsy. Another appealing facet of CTCs as a surrogate diagnostic tissue is the idea that CTCs could also constitute a "liquid biopsy" like cfDNA and provide real-time information about the patient's current disease state.9,10 Analysis of biomarker status in CTCs collected prior to treatment could potentially be used to select an appropriate targeted therapy, while repeated longitudinal sampling during treatment could be used to detect appearance of resistance markers and potentially enable switching to a more appropriate therapy.

A side-by-side comparison of EGFR mutation analysis in DNA extracted from circulating tumour cells (CTCs) versus cfDNA from plasma suggested that mutational analysis of CTCs captured on the CellSearch platform was low by comparison with the frequency of EGFR mutations identified in plasma.11 However, this limitation might be related to the CellSearch platform used,11 because other CTC platforms (eg, CTC biochip) have greater sensitivity and specificity for EGFR mutational analyses.12 New technologies, such as next generation sequencing and digital PCR (Figure 1), which can permit more precise quantification of cfDNA and also the CTCs, offer opportunities to design more appropriate treatments. Longitudinal analyses of EGFR and other mutations in cfDNA and CTCs might well prove to be an ideal non-invasive technique to be included in the oncologist's repertoire at the time of assigning or monitoring treatment in patients with NSCLC.

In this study, the investigators will collect blood from NSCLC patients who harbor EGFR mutation in biopsy specimens. Buffy coat and serum/plasma will be separated and DNA will be extracted. The investigators will check the EGFR mutation by next generation sequencing or digital PCR. Blood from volunteers without lung cancer patient will be also collected as standard. Serial follow-up the change of EGFR mutation every month in cancer patient will be correlated with clinical course. The Investigators hope the detection of EGFR mutation and serial change in the patient blood could offer as a marker for early diagnosis and early relapse.

Correlation Between EGFR Mutation Using cfDNAs and Circulating Tumor Cells in Patients With NSCLC

Correlation Between Epithelial Growth Factor Receptor(EGFR) Mutation Using cfDNA and CTCs in Patients With Non-Small Cell Lung Cancer

National Taiwan University Hospital

Rare Diseases

Neoplasm Metastasis

Adenocarcinoma of Lung

Lung Adenocarcinoma

Micronutrients

Hematinics

Vitamins

Docetaxel

Pemetrexed

Tubulin Modulators

Antimitotic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.

AUY922 was to be administered weekly.

Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.

Pemetrexed or docetaxel was to be was to be given once every three weeks.

AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.

AUY922

Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity

Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity

Novartis Pharmaceuticals

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

A Multicenter, Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations Who Have Progressed on Prior EGFR TKI Treatment

Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time.

OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.

Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1

TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1

The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1

To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.

Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.

TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1

Safety set: comprised of all participants who received at least one dose of study medication (AUY922, pemetrexed or docetaxel). In the safety set, patients were classified and analyzed according to the treatment received. Of the 59 participants randomized, only 52 received one dose of study medication.

AUY922 Arm

Chemotherapy Arm

Total

Age, Continuous

Sex: Female, Male

Full analysis set (FAS) comprised of all patients who were randomized to a study treatment.

The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results to terminate the study early due to futility, data was not collected for this assessment on many of the secondary endpoints.

Study Director

Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment \& an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped.

Progression Free Survival (PFS)

Complete Response (CR)

Partial Response (PR)

ORR (CR + PR)

The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.

Overall Response Rate (ORR)

The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of Dacomitinib in NSCLC	NCT04027647	NSCLC Stage III... NSCLC Stage III... NSCLC Stage IV Recurrent NSCLC EGFR Positive N...	Dacomitinib	18 Years -	National Cancer Centre, Singapore
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC	NCT05862194	Non-small Cell ...	Lazertinib Platinum-based ...	18 Years -	Yuhan Corporation
Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)	NCT04031898	Lung Cancer	Non Interventio...	-	AstraZeneca
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients	NCT03866499	NSCLC	BPI-7711 Gefitinib Placebo Tablet Placebo capsule	18 Years -	Beta Pharma, Inc.
Treatment Patterns, Outcomes and Testing in EGFRm NSCLC Patients With EGFR TKI 1L Across Europe (REFLECT)	NCT04031898	Lung Cancer	Non Interventio...	-	AstraZeneca
Correlation Between EGFR Mutation Using cfDNAs and Circulating Tumor Cells in Patients With NSCLC	NCT02422628	Lung Cancer		20 Years - 85 Years	National Taiwan University Hospital
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations	NCT01646125	Advanced Non Sm...	AUY922 Docetaxel Pemetrexed	18 Years -	Novartis
An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations	NCT01646125	Advanced Non Sm...	AUY922 Docetaxel Pemetrexed	18 Years -	Novartis

Spots Global Cancer Trial Database for egfr tki

Every month we try and update this database with for egfr tki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for egfr tki

Every month we try and update this database with for egfr tki cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for egfr tki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.