Non-small Cell Lung CancerPhase 2NCT03460275
Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer
A Phase 2 study testing Osimertinib Mesylate Tablets in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Based on the existing research results, Osimertinibi is effective not only for patients with sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no studies have been done so far regarding the difference in efficacy of various EGFR mutation subtypes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Osimertinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 26 Feb 2018to Dec 2020
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed unresectable locally advanced(Stage IIIB，not amenable to definitive multi-modality therapy)、metastatic(Stage IV)or recurrent EGFR mutation-positive Non-squamous NSCLC.( Diagnosis of NSCLC based on sputum cytology alone is not acceptable; If the specimen shows more than one tumor components, a pathological evaluation to classify the major histological subtype of the lung cancer must be performed.)Choose EGFR-TKIs as the first-line therapy.
- Patients with EGFR mutation(any form of EGFR mutation subtype except for EGFR exon 20 insertion mutation) detected by First generation sequencing(Sager sequencing) or next generation sequencing(NGS) from tissue sample includes fresh tissue or formalin-fixed paraffin-embedded(FFPE)sample or body fluid sample(blood, pleural effusion, cerebrospinal fluid ,etc.)
- Measurable disease by RECIST 1.1(At least one lesion that can be accurately measured at baseline as ≥10mm in the longest diameter, If the CT scan thickness >5mm, the lesion diameter is at least 2 times the scan thickness).
- Age≥18 years or≤75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)of 0 or 1.
- Estimated survival time(EST) no less than 12 weeks.
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- Adequate hematologic function:Absolute neutrophil count(ANC) ≥1.2 x 10^9/L;Platelets≥100 x 10^9/L;Hemoglobin≥9 g/dL(can be maintained by blood transfusion and exceeding 9 g/dL).
- Adequate hepatic function:Total bilirubin < 1.5 x upper limit of normal(ULN);For patients without liver metastases:Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) <2.5 x ULN;For patients with known hepatic metastases AST and ALT both <5 x ULN.
- Adequate renal function:Serum Creatinine≤1.5x ULN or creatinine clearance≥50mL/min;
- Within 7 days before included in the study:International normalized ratio(INR) ≤1.5, prothrombin time(PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
- Patients is willing and able to comply with the protocol for the duration of the study including scheduled visits and examinations including following up.
- Ability to understand and willingness to sign a written informed consent form.
Who cannot join
- Pathologic evaluation indicates NSCLC mixes with small-cell lung cancer(SCLC), adenosquamous carcinoma with component of squamous cell carcinoma comprises major part of the tumor.
- Prior therapy with 1)EGFR-TKIs such as Erlotinib and Gefitinib;2)EGFR inhibitor such as Cetuximab.
- Prior treatment with any systemic anti-cancer therapy for NSCLC including cytotoxic chemotherapy, targeted therapies(such as monoclonal antibody like Trastuzumab), investigational treatment(Do not include previously received adjuvant therapy or neoadjuvant therapy(adjuvant chemotherapy/radiation therapy(RT)).
- Radiotherapy treatment with a wide field of radiation for bone metastases to more than 30% of the bone marrow within 4 weeks of study entry; major surgery(including open surgical biopsy within 4 weeks prior to the administration of the study drug; Suffer major injuries; planned major surgery during the study.
- Patients with Spinal cord compression, severe neurological symptoms and unstable brain metastases (except for those patients who are asymptomatic or have had a stable neurological status for at least 2 weeks after symptomatic or supportive therapy).
- Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 or potent inhibitors or inducers of CYP3A4.
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- Physiological malfunction of upper digestive tract; malabsorption syndrome; Inability to swallow the formulated product.
- Any clinical evidence indicates:1) moderate to severe chronic obstructive pulmonary disease (COPD)[history of COPD or exposure to high risk factor for the disease; pulmonary function tests: forced expiratory volume in one second(FEV1)<80 %predicted, FEV1/ FVC<70%;With/without symptoms: shortness of breath, chronic cough, sputum production] ; 2)active interstitial lung disease(ILD)[ pulmonary function tests: FEV1/ FVC<70%, FEV1<80 %predicted, diffusing capacity of the lung for carbon monoxide (DLCO)< 40%;high-resolution computed tomography(HRCT) confirmed diffuse pulmonary interstitial lesions].
- Any diseases, metabolic disorders, physical examinations or laboratory results indicate the patient may have contradictions of the study drug or high risk factors of treatment-related complications.
- Any evidence of severe or uncontrolled systemic diseases, including active infection;uncontrolled hypertension;unstable angina; Angina within 3 months prior to study; congestive heart failure (NYHA Grade II or greater); prior myocardial infarction (NSTEMI or STEMI) within 6 months prior to study enrollment; severe arrhythmia requiring medical treatment; hepatic, renal or metabolic diseases.
- Active infection of human immunodeficiency virus (HIV).
- Patients with unhealing wound ,active peptic ulcer or bone fracture.
- Females who are 1)pregnant;2)breastfeeding;3)of reproductive potential planning to become pregnant; Males and females who are not using an effective method of birth control.
- History of allergic reactions attributed to compounds, or any of its excipients, of similar chemical or biologic composition to Osimertinib.
- Judgment by the Investigator that the patient should not participate in the study if the conditions of the patient is likely to compromise the efficacy and safety of the study or if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Malignancies except for NSCLC requiring treatments within the past 2 years prior to the administration of the study drug.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hao Long, professor, +862087343314, longhao@sysucc.org.cn
Ruping Xing, +862087343736, xingrp@sysucc.org.cn
- Recruiting
Sun Yat sen University cancer center
Guangzhou, Guangdong
Hao Long, prof, +86 2087343262, longhao@sysucc.org.cn
Ruping Xing, +86 2087343736, xingrp@sysucc.org.cn
About this study
Official title: Osimertinib as First-line Therapy for Patients With EGFR Mutation-positive Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer(NSCLC), a Single-Arm, Open-Lable, Prospective, Multicenter, Phase II Clinical Trial
Based on the existing research results, Osimertinibi is effective not only for patients with sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no studies have been done so far regarding the difference in efficacy of various EGFR mutation subtypes. Meanwhile, the presenting studies data of the safety and efficacy of Osimertinib as first-line therapy for NSCLC is very limited. Therefore, this study aims at assessing the safety and efficacy of Osimertinib as First-line therapy for patients with EGFR mutation-positive locally advanced or Metastatic Non-squamous NSCLC as well as the its difference in efficacy of various EGFR mutation subtypes.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Osimertinib Mesylate Tablets
- Keywords
- Osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osimertinib Mesylate TabletsDrug
Osimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first)
| Study group | Role | What they receive |
|---|---|---|
| single group | Other | Osimertinib Mesylate Tablets 80 mg, one time a day until disease progression Receives: Drug: Osimertinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
Patients were images with computed tomography (CT) scan
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start26 Feb 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460275
- Sponsor's protocol ID
- A2018-001
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osimertinib as First-line Therapy for Patients With EGFR Mutation-positive Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer(NSCLC), a Single-Arm, Open-Lable, Prospective, Multicenter, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03460275
- Acronym / sponsor ID
- A2018-001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Osimertinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Mar 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.
Based on the existing research results, Osimertinibi is effective not only for patients with sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no studies have been done so far regarding the difference in efficacy of various EGFR mutation subtypes. Meanwhile, the presenting studies data of the safety and efficacy of Osimertinib as first-line therapy for NSCLC is very limited. Therefore, this study aims at assessing the safety and efficacy of Osimertinib as First-line therapy for patients with EGFR mutation-positive locally advanced or Metastatic Non-squamous NSCLC as well as the its difference in efficacy of various EGFR mutation subtypes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Other | Drug: Osimertinib Mesylate TabletsOsimertinib Mesylate Tablets 80 mg, one time a day until disease progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed unresectable locally advanced(Stage IIIB，not amenable to definitive multi-modality therapy)、metastatic(Stage IV)or recurrent EGFR mutation-positive Non-squamous NSCLC.( Diagnosis of NSCLC based on sputum cytology alone is not acceptable; If the specimen shows more than one tumor components, a pathological evaluation to classify the major histological subtype of the lung cancer must be performed.)Choose EGFR-TKIs as the first-line therapy.
- Patients with EGFR mutation(any form of EGFR mutation subtype except for EGFR exon 20 insertion mutation) detected by First generation sequencing(Sager sequencing) or next generation sequencing(NGS) from tissue sample includes fresh tissue or formalin-fixed paraffin-embedded(FFPE)sample or body fluid sample(blood, pleural effusion, cerebrospinal fluid ,etc.)
- Measurable disease by RECIST 1.1(At least one lesion that can be accurately measured at baseline as ≥10mm in the longest diameter, If the CT scan thickness >5mm, the lesion diameter is at least 2 times the scan thickness).
- Age≥18 years or≤75 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)of 0 or 1.
Key exclusion criteria (16 listed)
- Pathologic evaluation indicates NSCLC mixes with small-cell lung cancer(SCLC), adenosquamous carcinoma with component of squamous cell carcinoma comprises major part of the tumor.
- Prior therapy with 1)EGFR-TKIs such as Erlotinib and Gefitinib;2)EGFR inhibitor such as Cetuximab.
- Prior treatment with any systemic anti-cancer therapy for NSCLC including cytotoxic chemotherapy, targeted therapies(such as monoclonal antibody like Trastuzumab), investigational treatment(Do not include previously received adjuvant therapy or neoadjuvant therapy(adjuvant chemotherapy/radiation therapy(RT)).
- Radiotherapy treatment with a wide field of radiation for bone metastases to more than 30% of the bone marrow within 4 weeks of study entry; major surgery(including open surgical biopsy within 4 weeks prior to the administration of the study drug; Suffer major injuries; planned major surgery during the study.
- Patients with Spinal cord compression, severe neurological symptoms and unstable brain metastases (except for those patients who are asymptomatic or have had a stable neurological status for at least 2 weeks after symptomatic or supportive therapy).
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 |
|---|---|---|
| Osimertinib Mesylate TabletsOsimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first) | Drug | single group |
Primary outcome
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
Time frame: eight weeks
Patients were images with computed tomography (CT) scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Osimertinib Mesylate Tablets in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 2 sites in China.
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 12 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Long, Prof (+86 2087343261, longhao@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 (time frame: eight weeks). 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 9 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.