Bronchial NeoplasmsPhase 1EATONNCT03516214
EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations
A Phase 1 study testing EGF816 and Trametinib in people with Bronchial Neoplasms, run by University of Cologne at 7 sites in 2 countries.
Trial summary
The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bronchial Neoplasms
- What is being tested?
- EGF816 and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Apr 2018to 27 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must have been obtained prior to any screening procedures.
- Patients (male or female) ≥ 18 years of age.
- Histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
- Presence of at least one measurable lesion according to RECIST v.1.1.
- ECOG performance status ≤ 2
- Patients must have NSCLC harbouring EGFR p.L858R or EGFR del19 as assessed by local testing.
Show all 13Show fewer
- Patients must be EGFR TKI treatment naïve (prior chemotherapy treatment is allowed) or must have progressed while on continuous treatment with a first- or second-generation EGFR TKI (EGFR p.T790M-negative or -positive) or must have progressed while on continuous treatment with osimertinib (EGFR p.T790M-negative or -positive)
- In patients who have received no prior EGFR TKI treatment, an archival biopsy sample, defined as a sample being obtained prior to any anti-cancer treatment is mandatory. If an archival biopsy fulfilling this criterion is not available, patients must be suitable and willing to undergo baseline biopsy according to the local institution's guidelines (newly obtained biopsy).
- In patients who have received prior EGFR TKI treatment, an archival biopsy sample, defined as a sample being obtained after or during progression upon the last anti-cancer treatment is mandatory. No consecutive line of treatment must have been given after collection of the rebiopsy and inclusion into this trial. If an archival rebiopsy fulfilling these criteria is not available, patients must be suitable and willing to undergo baseline biopsy according to the local institution's guidelines (newly obtained biopsy).
- In patients who have received prior EGFR TKI treatment, EGFRp.T790M mutation status must have been assessed by local testing in the tumour sample fulfilling the requirements of inclusion criterion 9.
- Patients who have received prior osimertinib treatment, may only be eligible if no standard treatment approach outside this trial is available or feasible (e.g. chemotherapy)
- Patients who have progressed while on continuous treatment with a first- or second-generation EGFR inhibitor and whose tumour has been tested EGFR p.T790M-negative may only be eligible if no standard treatment approach outside this trial is available or feasible (e.g. chemotherapy).
- In patients who have received prior EGFR TKI treatment, progression of disease according to RECIST v1.1 while on continuous treatment with an EGFR TKI (e.g. erlotinib, gefitinib, afatinib or osimertinib) must be documented.
Who cannot join
- History of allergic reactions or hypersensitivity to one of the study drugs or to any component of the study drugs
- Prior treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)
- Prior treatment with any agent known to inhibit MEK/ERK or other mediators of RAS pathway.
- Patients with high level MET amplification in the archival or newly obtained biopsy sample as determined by local testing. High-level MET amplification is defined as: a) a MET/CEN7 ratio ≥2.0 and/or b) an average MET gene copy number per cell of ≥6.0 [modified Schildhaus et al., 2015].
- Patients with EGFR mutations other than EGFR del19, p.L858R or p.T790M.
- Patients with brain metastases. However, if radiation therapy and/or surgery has been completed at least 4 weeks prior to screening for the trial and evaluation by CT (with contrast enhancement) or MRI at study baseline demonstrates the disease to be stable and if the patient remains asymptomatic and off steroids, then patients with brain metastases may be enrolled.
Show all 49Show fewer
- Patients with presence or history of carcinomatous meningitis.
- Any acute or chronic medical, mental or psychological condition, which in the opinion of the investigator would not permit the patient to participate or complete the study or understand the patient information
- History of hepatitis B (HBV) or hepatitis C (HCV) or positive result in mandatory testing for acute or chronic hepatitis B or hepatitis C
- Known HIV infection or history of HIV infection independent from the cellular immune status
- Patients who receive any continuous, long term immunosuppressive treatment, including long term treatment with steroids at immunosuppressive doses at the time of study entry
- Patients who underwent bone marrow or solid organ transplantation, including patients who do not receive any immunosuppressive treatment.
- Presence or history of any other primary malignancy other than NSCLC within 5 years prior to enrolment into the trial. Except from this: Adequately treated basal or squamous cell carcinoma of the skin or any adequately treated in situ carcinoma
- Any of the following within 6 months prior to first trial drug administration: Myocardial infarction (NSTEMI or STEMI), severe/unstable angina pectoris, symptomatic congestive heart failure (> NYHA II), uncontrolled hypertension, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, atrial fibrillation of CTCAE Grade ≥ 2, ongoing cardiac dysrhythmias of CTCAE Grade ≥ 2, including corrected QTcF prolongation of > 480 ms,
- Aortic valve stenosis with mean gradient ≥ 25 mmHg and aortic valve area of ≤ 1.5 cm2
- Any other cardiac valve abnormality of more than mild degree/stage
- Left ventricular ejection fraction (LVEF) of < 50 %
- History of congenital long QT-syndrome or Torsades de Pointes
- History of retinal vein occlusion (RVO) or retinal pigment epithelial detachment (RPED)
- Unable or unwilling to swallow tablets or capsules
- Patients with impaired gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of EGF816 (e.g., ulcerative diseases, uncontrolled nausea, vomiting diarrhoea, or malabsorption syndromes
- Patients have received anticancer treatment within the following time frames prior to the first dose of study treatment:
- Conventional cytotoxic chemotherapy: ≤ 4 weeks (≤ 6 weeks for nitrosoureas, mitomycin-C and suramin)
- Biological therapy (e.g., antibodies, excluding PD-1 or PD-L1 antibodies): ≤ 4 weeks
- PD-1/PD-L1 antibodies (e.g., nivolumab, pembrolizumab): ≤ 5 half-times
- Non-cytotoxic anti-cancer therapeutic (e.g., tyrosine kinase inhibitors): ≤ 5 half-times or ≤ 1 weeks (whichever is longer)
- Other investigational agent: ≤ 4 weeks
- Radiation therapy (excluding palliative radiation, e.g., of bone metastases): ≤ 4 weeks
- Major surgery (excluding minor surgical interventions, e.g., vascular device implantation): ≤ 2 weeks
- Laboratory values as listed below, that cannot be corrected to normal limits within screening :
- Absolute Neutrophil Count (ANC) < 1.5 x 10^9/L
- Haemoglobin (Hb) < 9 g/dL
- Platelets (PLT) < 100 x 10^9/L
- Total bilirubin > 1.5 x upper limit of normal (ULN). For patients with confirmed Gilbert's disease total bilirubin > 2.5 x ULN
- AST and/or ALT > 3 x ULN
- AST and/or ALT > 5 x ULN in patients with liver involvement
- Serum creatinine > 1.5 x ULN
- Measured or calculated creatinine clearance ≤ 45 mL/min
- Serum amylase and/or lipase CTCAE Grade > 2
- Potassium, magnesium, phosphorus, total calcium (corrected from serum albumin) > ULN
- Patients receiving treatment with any medication that are known to be
- Strong inhibitors or inducers of CYP3A4/5
- Substrates of CYP2D6 with narrow therapeutic index
- and that cannot be discontinued at least 7 days prior to the first dose of the study drugs.
- For further information please refer to Section 11.7 and the Concomitant Medication Manual.
- Patients with a history of or presence of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
- Pregnancy or breastfeeding/nursing women
- Women of child-bearing potential (for definition see Section 8.3.3) unless they use highly effective methods of contraception during treatment and for four months after withdrawal of study treatment (for methods of contraception see Section 8.3.4)
- Sexually active males unless they use a condom during intercourse for the time of study treatment and for four months after the withdrawal of study treatment.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
University Hospital of Cologne
Cologne
University Hospital Dresden
Dresden
University Hospital Essen
Essen
University Hospital Frankfurt
Frankfurt
University Hospital Würzburg
Würzburg
Spain2 sites
Instituto Oncológico Dr. Rosell
Barcelona, 08028
Vall d'Hebron University Hospital
Barcelona
About this study
Official title: An Open-label, Multicenter, Phase I Dose-escalation Trial of EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer and Acquired EGFR p.T790M-positive Resistance to 1st or 2nd Generation EGFR TKI Therapy Remark: According to Version V02_0 of the Protocol, Patients May Also be Eligible if EGFR TKI-treatment naïve, EGFR p.T790M-negative at Progression While on EGFR TKI Therapy or After Progression While on Osimertinib Treatment
The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).
Read the detailed description
The population of interest for this trial is defined by patients with non-small cell lung cancer (NSCLC) harbouring the sensitizing EGFR mutations del19 or p.L858R. Patients may be enrolled in first- or later lines of therapy and independently of the prior (approved) EGFR inhibitor administered and independently of the EGFR p.T790M-status. Those individuals whose tumors harbour high-level amplifications of MET or other EGFR mutations except for del19, p.L858R or p.T790M will be excluded from the trial. The molecular status must have been determined in a biopsy collected at progression to the last systemic and prior to the initiation of the trial treatment
The aim of the trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) for a continuous treatment with the 3rd generation EGFR inhibitor EGF816 and the MEK inhibitor trametinib.
The recommendations for dose level escalations will be based on an "up-and-down" design proposed by Storer, 1989. The dose limiting toxicity (DLT) period comprises the first 28 days of treatment with EGF816 and trametinib at the designated dose level (Cycle 1).
PK parameters of the combination treatment will be assessed for every dose level in every patient during the dose-escalation part.
Preliminary efficacy of EGF816 and trametinib in the trial population will be assessed by RECIST (v1.1) analysis of scheduled CT scans (every 8 weeks or as clinically indicated.
Throughout the study blood samples will be collected to monitor cell free plasma DNA (cfDNA).
Patients who develop resistance upon treatment with the study drugs will undergo a rebiopsy to identify potential mechanisms of resistance.
- Conditions
- Bronchial Neoplasms
- Being tested
- EGF816, Trametinib
- Keywords
- acquired resistance, EGFR p.T790M-positive, osimertinib resistance, EGFR p.T790M-negative
- Medical subject headings
- Bronchial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGF816Drug
Also called Nazartinib
Continuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816.
TrametinibDrug
Also called Mekinist
Continuous oral treatment (once daily) with the MEK inhibitor trametinib.
| Study group | Role | What they receive |
|---|---|---|
| EGF816 (nazartinib) and trametinib | Experimental | Patients will receive oral EGF816 (nazartinib) and trametinib at escalating dose levels. Intra-patient dose-escalation will not be allowed. Receives: Drug: EGF816; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting-toxicities (DLT) of the combination of EGF816 and trametinib to assess the maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
Incidence of dose-limiting-toxicities (DLT) that occur during the DLT period (i.e. first 4 weeks of treatment) of each patient in the dose-escalation part (N=18)
Measured: Approximately one and a half years (from FPFV until the end of the DLT period of the last patient included into the trial or until death of the last patient, whichever occurs first)
Secondary outcomes (9)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: Approximately four years (from FPFV until the completion of the clinical trial)
Number of patients who experienced dose interruptions or reductions
Measured: Approximately four years (from FPFV until the end-of-treatment visit of the last patient or until death of the last patient, whichever occurs first)
Objective response rate (ORR) according to RECIST 1.1
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Disease control rate (DCR) according to RECIST 1.1
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Progression-free survival (PFS) according to RECIST 1.1
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Duration of response (DOR) according to RECIST 1.1
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Time to response (TTR) according to RECIST 1.1
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
overall survival (OS)
Measured: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Plasma concentration vs time profiles - plasma PK parameters of EGF816 and trametinib
Measured: Approximately two years (from FPFV until the completion of four months of treatment of the last patient or until death of the last patient, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start25 Apr 2018
- Primary completion30 Sep 2022
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Juergen Wolf, University of Cologne
- Investigators
- Jürgen Wolf, Prof. Dr., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516214
- Sponsor's protocol ID
- Uni-Koeln-1784
- Other IDs
- 2016-003944-35, AIO-TRK-0216, 2016
- Acronym
- EATON
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2018
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Dose-escalation Trial of EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer and Acquired EGFR p.T790M-positive Resistance to 1st or 2nd Generation EGFR TKI Therapy Remark: According to Version V02_0 of the Protocol, Patients May Also be Eligible if EGFR TKI-treatment naïve, EGFR p.T790M-negative at Progression While on EGFR TKI Therapy or After Progression While on Osimertinib Treatment
- ClinicalTrials.gov ID
- NCT03516214
- Acronym / sponsor ID
- EATON / Uni-Koeln-1784
- Conditions
- Bronchial Neoplasms
- Keywords
- acquired resistance, EGFR p.T790M-positive, osimertinib resistance, EGFR p.T790M-negative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).
Detailed description
The population of interest for this trial is defined by patients with non-small cell lung cancer (NSCLC) harbouring the sensitizing EGFR mutations del19 or p.L858R. Patients may be enrolled in first- or later lines of therapy and independently of the prior (approved) EGFR inhibitor administered and independently of the EGFR p.T790M-status. Those individuals whose tumors harbour high-level amplifications of MET or other EGFR mutations except for del19, p.L858R or p.T790M will be excluded from the trial. The molecular status must have been determined in a biopsy collected at progression to the last systemic and prior to the initiation of the trial treatment
The aim of the trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) for a continuous treatment with the 3rd generation EGFR inhibitor EGF816 and the MEK inhibitor trametinib.
The recommendations for dose level escalations will be based on an "up-and-down" design proposed by Storer, 1989. The dose limiting toxicity (DLT) period comprises the first 28 days of treatment with EGF816 and trametinib at the designated dose level (Cycle 1).
PK parameters of the combination treatment will be assessed for every dose level in every patient during the dose-escalation part.
Preliminary efficacy of EGF816 and trametinib in the trial population will be assessed by RECIST (v1.1) analysis of scheduled CT scans (every 8 weeks or as clinically indicated.
Throughout the study blood samples will be collected to monitor cell free plasma DNA (cfDNA).
Patients who develop resistance upon treatment with the study drugs will undergo a rebiopsy to identify potential mechanisms of resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGF816 (nazartinib) and trametinib | Experimental | Drug: EGF816, Drug: TrametinibPatients will receive oral EGF816 (nazartinib) and trametinib at escalating dose levels. Intra-patient dose-escalation will not be allowed. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent must have been obtained prior to any screening procedures.
- Patients (male or female) ≥ 18 years of age.
- Histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or metastatic (stage IV) non-small cell lung cancer.
- Presence of at least one measurable lesion according to RECIST v.1.1.
- ECOG performance status ≤ 2
Key exclusion criteria (49 listed)
- History of allergic reactions or hypersensitivity to one of the study drugs or to any component of the study drugs
- Prior treatment with any investigational agent known to inhibit EGFR (mutant or wild-type)
- Prior treatment with any agent known to inhibit MEK/ERK or other mediators of RAS pathway.
- Patients with high level MET amplification in the archival or newly obtained biopsy sample as determined by local testing. High-level MET amplification is defined as: a) a MET/CEN7 ratio ≥2.0 and/or b) an average MET gene copy number per cell of ≥6.0 [modified Schildhaus et al., 2015].
- Patients with EGFR mutations other than EGFR del19, p.L858R or p.T790M.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGF816Also: NazartinibContinuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816. | Drug | EGF816 (nazartinib) and trametinib |
| TrametinibAlso: MekinistContinuous oral treatment (once daily) with the MEK inhibitor trametinib. | Drug | EGF816 (nazartinib) and trametinib |
Primary outcome
Incidence of dose-limiting-toxicities (DLT) of the combination of EGF816 and trametinib to assess the maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
Time frame: Approximately one and a half years (from FPFV until the end of the DLT period of the last patient included into the trial or until death of the last patient, whichever occurs first)
Incidence of dose-limiting-toxicities (DLT) that occur during the DLT period (i.e. first 4 weeks of treatment) of each patient in the dose-escalation part (N=18)
9 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: Approximately four years (from FPFV until the completion of the clinical trial)
Number of patients who experienced dose interruptions or reductions
Time frame: Approximately four years (from FPFV until the end-of-treatment visit of the last patient or until death of the last patient, whichever occurs first)
Objective response rate (ORR) according to RECIST 1.1
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Disease control rate (DCR) according to RECIST 1.1
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Progression-free survival (PFS) according to RECIST 1.1
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Duration of response (DOR) according to RECIST 1.1
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Time to response (TTR) according to RECIST 1.1
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
overall survival (OS)
Time frame: Approximately 4 years (from FPFV until the progression of the last patient treated within the trial or until death of the last patient, whichever occurs first)
Plasma concentration vs time profiles - plasma PK parameters of EGF816 and trametinib
Time frame: Approximately two years (from FPFV until the completion of four months of treatment of the last patient or until death of the last patient, whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchial Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Wolf, Prof. Dr. principal investigator
University Hospital of Cologne
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EGF816 and Trametinib in people with Bronchial Neoplasms, run by University of Cologne at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting-toxicities (DLT) of the combination of EGF816 and trametinib to assess the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) (time frame: Approximately one and a half years (from FPFV until the end of the DLT period of the last patient included into the trial or until death of the last patient, whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.