NSCLC, Stage IPhase 2NCT05686434
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
A Phase 2 study testing Osimertinib in people with NSCLC, Stage I, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Stage I
- What is being tested?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2022to 14 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
- Male and female, ≥18 years old;
- Primary non-squamous NSCLC confirmed histologically by the central laboratory;
- Brain imaging examinations should be performed before surgery or enrollment;
- The patient was clinically confirmed as stage I by imaging, and was staged according to the eighth edition of TNM lung cancer;
- As confirmed by the central laboratory, the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M;
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- The primary NSCLC must be completely resected by surgery, and all lesions must be removed at the end of the surgery.All surgical margins must be negative. Lobectomy can be done with open surgery or thoracoscopic (VATS);
- Central laboratory pathology confirmed solid and/or micropapillary component ≥10%, or STAS;
- The interval from operation to adjuvant Osimertinib treatment is no more than 10 weeks;
- WHO physical status score is 0~1;
- Paraffin-embedded sections (10-15 sheets), or wax blocks or fresh frozen tissue for surgical resection of the lesion should be provided;
- At least 2 weeks prior to initiation of the study drug, female subjects should be using highly effective contraceptive methods, pregnancy tests must be negative, and there must be no ongoing breastfeeding prior to initiation of the drug, or else one of the following criteria must be met at the time of screening to demonstrate the possibility of non-fertility:
- Postmenopausal was defined as over 50 years of age and amenorrhea for at least 12 months after cessation of all exogenous hormone therapy.
- Women under 50 should be considered to have stopped menstruating if they have stopped menstruating for 12 months or more after stopping exogenous hormone therapy and their LH and FSH levels are within the agency's postmenopausal range.
- Irreversible surgical sterilization recorded by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation;Male subjects must be willing to use barrier contraception.
Who cannot join
- Exposure to other antitumor therapies before enrollment;
- Patients who only received segmental resection and wedge resection;
- History of other malignancies, other than non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and the treating physician has determined that there is no evidence of disease recurrence for 5 years after treatment;
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any condition that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Omission requirement for screening chronic diseases;
- Any of the following cardiac criteria:
- QTc values obtained using screening clinic ECG machines mean resting corrected QT interval (QTc) > 470 milliseconds from 3 electrocardiogram (ECG) tests,
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- Any abnormalities in rhythm, conduction, or morphology of a clinically significant resting ECG, such as left bundle branch block, third degree heart block, and second degree heart block.
- Any factors that increase the risk of prolonged QTc or arrhythmia events, such as heart failure, hypokalemia, congenital long QT syndrome, sudden unexplained death under 40 years of age in a first-degree relative or any concomitant medication known to prolong the QT interval.
- Any evidence of prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or active interstitial lung disease;
- Lack of adequate bone marrow reserve or organ function (demonstrated by any of the following laboratory values: absolute neutrophil count <1.5×10⁹/L;Platelet count <100×10⁹/L;Hemoglobin <90 g/L;Alanine aminotransferase > 2.5 ULN; Aspartate aminotransferase >2.5 times ULN;Total bilirubin > 1.5 ULN;Serum creatinine >1.5 ULN with creatinine clearance <50 mL/min [as measured or calculated by Cockcroft and Gault formulas] - creatinine clearance only needs to be confirmed when creatinine >1.5 ULN);
- History of hypersensitivity to active or inactive excipients of Osimertinib or drugs with similar chemical structures or classes to ocitinib;
- Uncontrolled nausea and vomiting, chronic gastrointestinal illness, inability to swallow formulated drugs, or prior major bowel resection that prevents adequate absorption of Osimertinib;
- Any evidence of corneal injury confirmed by ophthalmic examination through slit lamp evaluation;
- The patient is pregnant or nursing;
- History of allergy to ocitinib active or inactive excipients or drugs similar in chemical structure or class to Osimertinib;
- If the patient is unlikely to comply with study procedures, restrictions, and requirements, the investigator judges that the patient should not participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Chen Chen, 13920761627, chen_checn@tmu.edu.cn
About this study
Official title: Efficacy and Safety of Osimertinib Adjuvant Therapy in High-risk Stage I EGFRm NSCLC After Complete Resection(OSTAR): a Prospective, Single-arm Study
This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).
Read the detailed description
Patients will be tested for the status of EGFR-sensitive mutations prior to enrollment and confirmed positive by central laboratory testing.The surgically removed tumor foci will be confirmed by central laboratory pathologic examination for their pathological subtypes, solid and/or micropapillary components ≥10%, and/or STAS positive.
These patients had undergone complete resection of the tumor, and 65 patients who met the criteria for inclusion were enrolled to receive Osimertinib. Patients had to be enrolled and given Osimertinib within 10 weeks of complete resection.The dose of Osimertinib in this study was 80 mg once a day and the planned duration of treatment was 3 years (156 weeks). Patients will be evaluated for safety and efficacy at baseline, at week 12, and every 12 weeks thereafter until completion or termination of treatment. Patients were followed up every 24 weeks to 5 years (264 weeks) and annually thereafter for disease recurrence.
Overall survival (OS) was observed every 24 weeks for 5 years (264 weeks) after disease recurrence and annually thereafter.The primary endpoint of the study was 3-year DFS rate. Disease-free survival (DFS) should be calculated from the date of entry on Osimertinib to the date of disease recurrence or death.
After the primary analysis (3-year DFS rate), patients' survival status will be followed up according to the simplified study plan (OS analysis period) until the final OS analysis data is available. In the event of disease recurrence, patients will be re-staged and all sites of recurrence of NSCLC will be recorded. It will be up to the doctor to decide what treatment the patient will receive after a relapse;and cancer treatment after recurrence will be documented.Taken together, all primary, secondary, and exploratory endpoints in this study strongly describe the overall benefit of adjuvant Osimertinib in a population of patients with high-risk EGFRm+ stage I NSCLC who have been surgically completely resected.
- Conditions
- NSCLC, Stage I
- Being tested
- 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.
OsimertinibDrug
Also called Tagrisso, AZD9291
This is a prospective, open, single-center, single-arm phase II clinical study with EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory，to evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib adjuvant therapy group | Experimental | Patients must be enrolled within 10 weeks of complete surgical excision and receive oral Osimertinib at a dose of 80 mg once a day for a planned duration of 3 years (156 weeks). Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year DFS rate
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
Measured: From date of randomisation up to approximately 5 years
Secondary outcomes (6)
DFS
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment.
Measured: From date of randomisation up to approximately 10 years
3-year OS rate
Defined as the percentage of patients alive at 3 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Measured: From date of randomization up to approximately 5 years
5-year OS rate
Defined as the percentage of patients alive at 5 years, respectively, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Measured: From date of randomization up to approximately 5 years
OS
OS is defined as the time from the date of randomisation until death due to any cause.
Measured: From date of randomization up to approximately 10 years
Safety and tolerability in overall population
AEs graded by CTCAE version 5.0
Measured: From date of randomisation up to approximately 10 years
health-related quality of life and Symptoms (HRQoL)
Change from baseline will be calculated for each domain and summary scale at each scheduled post-baseline assessment. The SF-36 includes eight domains: Physical Functioning (PF); Role Limitations-Physical (RP), Vitality (VT), General Health Perceptions (GH), Bodily Pain (BP), Social Function (SF), Role Limitations-Emotional (RE), and Mental Health (MH) and two summary scores: The Physical Component Summary (PCS) and Mental Component Summary (MCS). Final scores for each scale range from 0-100 with higher scores indicating better health.
Measured: Measured by SF-36 Questionnaire at baseline, 12 week,and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start14 Oct 2022
- Primary completion14 Oct 2024 (estimated)
- Study completion14 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 65 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongsheng Yue, Principal investigator, Tianjin Medical University Cancer Institute and HospitalRicheng Jiang, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686434
- Sponsor's protocol ID
- NSCLC-Osimertinib-001
- Status last verified
- Dec 2022
- First submitted
- 6 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Osimertinib Adjuvant Therapy in High-risk Stage I EGFRm NSCLC After Complete Resection(OSTAR): a Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT05686434
- Acronym / sponsor ID
- NSCLC-Osimertinib-001
- Conditions
- NSCLC, Stage I
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 14 Oct 2024 (estimated)
- Study completion
- 14 Oct 2029 (estimated)
- First posted
- 17 Jan 2023 (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.
This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).
Detailed description
Patients will be tested for the status of EGFR-sensitive mutations prior to enrollment and confirmed positive by central laboratory testing.The surgically removed tumor foci will be confirmed by central laboratory pathologic examination for their pathological subtypes, solid and/or micropapillary components ≥10%, and/or STAS positive.
These patients had undergone complete resection of the tumor, and 65 patients who met the criteria for inclusion were enrolled to receive Osimertinib. Patients had to be enrolled and given Osimertinib within 10 weeks of complete resection.The dose of Osimertinib in this study was 80 mg once a day and the planned duration of treatment was 3 years (156 weeks). Patients will be evaluated for safety and efficacy at baseline, at week 12, and every 12 weeks thereafter until completion or termination of treatment. Patients were followed up every 24 weeks to 5 years (264 weeks) and annually thereafter for disease recurrence.
Overall survival (OS) was observed every 24 weeks for 5 years (264 weeks) after disease recurrence and annually thereafter.The primary endpoint of the study was 3-year DFS rate. Disease-free survival (DFS) should be calculated from the date of entry on Osimertinib to the date of disease recurrence or death.
After the primary analysis (3-year DFS rate), patients' survival status will be followed up according to the simplified study plan (OS analysis period) until the final OS analysis data is available. In the event of disease recurrence, patients will be re-staged and all sites of recurrence of NSCLC will be recorded. It will be up to the doctor to decide what treatment the patient will receive after a relapse;and cancer treatment after recurrence will be documented.Taken together, all primary, secondary, and exploratory endpoints in this study strongly describe the overall benefit of adjuvant Osimertinib in a population of patients with high-risk EGFRm+ stage I NSCLC who have been surgically completely resected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osimertinib adjuvant therapy group | Experimental | Drug: OsimertinibPatients must be enrolled within 10 weeks of complete surgical excision and receive oral Osimertinib at a dose of 80 mg once a day for a planned duration of 3 years (156 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;
- Male and female, ≥18 years old;
- Primary non-squamous NSCLC confirmed histologically by the central laboratory;
- Brain imaging examinations should be performed before surgery or enrollment;
- The patient was clinically confirmed as stage I by imaging, and was staged according to the eighth edition of TNM lung cancer;
Key exclusion criteria (16 listed)
- Exposure to other antitumor therapies before enrollment;
- Patients who only received segmental resection and wedge resection;
- History of other malignancies, other than non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and the treating physician has determined that there is no evidence of disease recurrence for 5 years after treatment;
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any condition that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Omission requirement for screening chronic diseases;
- Any of the following cardiac criteria:
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 |
|---|---|---|
| OsimertinibAlso: Tagrisso, AZD9291This is a prospective, open, single-center, single-arm phase II clinical study with EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory，to evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread). | Drug | Osimertinib adjuvant therapy group |
Primary outcome
3-year DFS rate
Time frame: From date of randomisation up to approximately 5 years
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
6 secondary outcomes
DFS
Time frame: From date of randomisation up to approximately 10 years
3-year OS rate
Time frame: From date of randomization up to approximately 5 years
5-year OS rate
Time frame: From date of randomization up to approximately 5 years
OS
Time frame: From date of randomization up to approximately 10 years
Safety and tolerability in overall population
Time frame: From date of randomisation up to approximately 10 years
health-related quality of life and Symptoms (HRQoL)
Time frame: Measured by SF-36 Questionnaire at baseline, 12 week,and then every 24 weeks until study complete, disease recurrence or other discontinuation criteria met, up to approximately 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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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.
Dongsheng Yue principal investigator
Tianjin Medical University Cancer Institute and Hospital
Richeng Jiang principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site 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 in people with NSCLC, Stage I, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 15 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: looking for participants now, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chen chen (13920761627, chen_checn@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS rate (time frame: From date of randomisation up to approximately 5 years). 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 17 Jan 2023.