Lung Neoplasms, Non-Small Cell Lung CancerPhase 3PTR-2NCT07738172
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer
A Phase 3 study testing Primary Tumor Resection and Osimertinib in people with Lung Neoplasms, Non-Small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Non-Small Cell Lung Cancer
- What is being tested?
- Primary Tumor Resection and Osimertinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2026to 1 Aug 2031
- Phase
- Phase 3
- 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
- Histologically or cytologically confirmed NSCLC.
- Age ≥18 years.
- AJCC 8th edition stage IV NSCLC.
- EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.
- WHO performance status 0-1. Patients with brain metastases must be conscious; patients with bone metastases must not have irreversible severe events such as severe pathological fracture.
- The primary lung tumor is considered resectable by the investigator and thoracic surgeon, with surgery intended for maximal regional control.
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- The patient is able to take oral medication and is expected to receive first-line osimertinib induction therapy.
- Major organ function and pulmonary reserve are adequate to tolerate the planned surgery.
- Subjects may proceed to randomization only if all of the following criteria are met:
- The subject has received first-line protocol-defined osimertinib induction according to the study protocol, consisting of osimertinib once daily (QD) for 12 weeks, and has completed the pre-randomization evaluation.
- Restaging imaging has been completed after 12 weeks of induction therapy, and the response is assessed as partial response (PR) or stable disease (SD) according to RECIST version 1.1. In addition, the maximal diameter of the target primary lung tumor before surgery must be greater than the sum of the maximal diameters of the metastatic tumors. PET-CT before surgery or before randomization is recommended to evaluate for newly developed extrathoracic metastases, bone metastases, or mediastinal lymph node involvement. If PET-CT is not performed, the preoperative or pre-randomization imaging assessment should include contrast-enhanced CT scans of the chest and abdomen, including the liver and adrenal glands; brain imaging should be completed with contrast-enhanced CT or MRI. Pleural or peritoneal metastasis confined to a single cavity (for example, unilateral pleural disease) and amenable to treatment may be considered a single metastatic lesion.
- Disease distribution after induction therapy meeting all of the following criteria:
- no more than 3 involved organs;
- one dominant pulmonary primary lesion;
- the maximal diameter of the dominant pulmonary primary lesion is greater than any single distant metastatic lesion;
- total number of distant metastatic lesions fewer or equal to 10.
- After 12 weeks of protocol-defined osimertinib induction, the patient must have PR or SD by RECIST 1.1 and remain eligible for randomization.
- If either of the following conditions is present on restaging imaging:
- Poor primary tumor response: the sum of the longest diameters (SLD) of the primary lung tumor after treatment falls within the range of less than 30% decrease and less than 20% increase (that is, -30% < SLD change < +20%); or
- Polymetastatic condition: the total number of distant metastatic lesions is 6 to 10,
- then the treatment response of the other distant target metastatic lesions must additionally meet an SLD reduction of at least 30% in order for the subject to remain eligible for randomization.
- Estimated life expectancy is greater than 3 months, as judged by the investigator.
- The subject remains suitable for primary lung tumor resection, as assessed by the investigator and thoracic surgeon, and has no major comorbidity that would increase surgical risk to an unacceptable level.
- Exclusion criteria Subjects meeting any of the following criteria will be excluded from this study. If any of these conditions are identified only after completion of the 12-week induction phase, the subject will not proceed to randomization.
- Pathology other than non-small cell lung cancer (NSCLC), or failure to meet the EGFR mutation criteria specified in this study.
- EGFR mutation other than exon 19 deletion or exon 21 L858R.
- Involvement of more than 3 organs by tumor lesions at post-induction restaging, before randomization.
- Total number of distant metastatic lesions greater than 10 at post-induction restaging, before randomization.
- No clearly dominant primary pulmonary lesion, or the maximal diameter of the dominant primary pulmonary lesion is not greater than any individual distant metastatic lesion at post-induction restaging, before randomization
- Diffuse pleural or peritoneal carcinomatosis that cannot be clearly localized and treated with local definitive therapy.
- Progressive disease (PD) on imaging evaluation after 12 weeks of protocol-defined osimertinib induction.
- Judged by the investigator or thoracic surgeon to be no longer suitable for thoracic surgery after induction therapy.
- Any systemic therapy other than the protocol-defined osimertinib induction for the current stage IV NSCLC.
- Any prior EGFR-TKI, chemotherapy, immunotherapy, or other systemic anticancer therapy for the current stage IV NSCLC, except for the protocol-defined osimertinib induction.
- Pregnant, breastfeeding, or planning pregnancy during the study period.
- Any condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study, or highly likely to be unable to comply with the study procedures, restrictions, or requirements.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taipei City, 100
Dobbie Pei-Hsing Chen, MD, +886-2-2322-0322, chenph@ntu.edu.tw
Chong-Jen Yu, MD
About this study
Official title: A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy
Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.
This multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.
All participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.
Read the detailed description
This is a multicenter, open-label, parallel-group, randomized controlled phase III trial evaluating primary lung tumor resection in patients with EGFR-mutated oligometastatic stage IV non-small cell lung cancer treated with first-line osimertinib.
The study includes two eligibility assessments. During the first assessment, participants must have histologically or cytologically confirmed stage IV non-small cell lung cancer harboring an EGFR exon 19 deletion or exon 21 L858R mutation, a dominant and potentially resectable primary lung tumor, no more than three involved organs, and no more than 10 distant metastatic lesions.
All enrolled participants will receive protocol-defined induction treatment with osimertinib 80 mg orally once daily for 12 weeks. After induction, participants will undergo restaging. Only participants with partial response or stable disease according to RECIST version 1.1 who remain medically and technically suitable for primary lung tumor resection will undergo randomization.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two groups:
- Osimertinib alone; or
- Primary lung tumor resection followed by continued osimertinib. Randomization will be stratified by EGFR mutation subtype, presence of brain metastases, and number of distant metastatic lesions.
Participants assigned to the surgical group will undergo therapeutic resection of the primary lung tumor after randomization. The surgical approach and extent of resection will be selected by the treating thoracic surgeon according to accepted standards of care. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate. Participants in both groups will continue osimertinib until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.
Tumor assessments will be performed approximately every 12 weeks and evaluated according to RECIST version 1.1. Local treatment of distant metastatic lesions may be provided when clinically indicated according to standard of care and institutional practice for the PTR group, as permitted by the protocol.
The primary objective is to compare progression-free survival between the two treatment groups. Secondary and exploratory objectives include overall survival, treatment-related adverse events, pathologic response of the primary tumor, quality of life, local-regional progression-free survival, distant metastasis progression-free survival, brain metastasis progression-free survival, polymetastatic progression-free survival, systemic therapy-free survival, and exploratory molecular biomarker outcomes.
- Being tested
- Primary Tumor Resection, Osimertinib
- Keywords
- non-small cell lung cancer (NSCLC), EGFR mutation, stage IV non-small-cell lung cancer, Osimertinib, Primary tumor resection, Oligometastatic non-small cell lung cancer, Local consolidative therapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Tumor ResectionProcedure or surgery
Participants assigned to the experimental arm will undergo therapeutic resection of the primary lung tumor after randomization. Acceptable procedures include lobectomy, sleeve lobectomy, bilobectomy, segmentectomy, and wedge resection. The surgical approach may include video-assisted thoracic surgery or thoracotomy. Pneumonectomy and sleeve pneumonectomy are not permitted. The procedure is intended to achieve maximal regional disease control and tumor-free resection margins whenever feasible.
OsimertinibDrug
Osimertinib will be administered orally at a dose of 80 mg once daily as first-line systemic therapy. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or fulfillment of other protocol-defined discontinuation criteria. Dose interruption or reduction will be permitted for treatment-related adverse events according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Osimertinib Alone | Active comparator | Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will continue osimertinib 80 mg once daily until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation. Receives: Drug: Osimertinib |
| Osimertinib Plus Primary Tumor Resection | Experimental | Participants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will undergo therapeutic resection of the primary lung tumor. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate and will be continued until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation. Receives: Procedure: Primary Tumor Resection; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-free survival is defined as the time from randomization to the first documented occurrence of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate disease assessment.
Measured: From randomization to disease progression or death, assessed up to 24 months after randomization.
Secondary outcomes (4)
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the end of follow-up will be censored at the date they were last known to be alive.
Measured: From randomization to death from any cause, assessed up to 48 months after randomization.
Number of Participants With Treatment-Related Adverse Events
Treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number and proportion of participants experiencing treatment-related adverse events will be summarized by treatment group.
Measured: From the first dose of osimertinib through 28 days after the last dose
Pathologic Response of the Primary Lung Tumor
Percentage of residual viable tumor cells in the resected primary lung tumor. Major pathologic response is defined as ≤10% residual viable tumor, and pathologic complete response as no residual viable tumor. This outcome will be assessed only in the surgical arm.
Measured: At primary lung tumor resection, generally within 12 weeks after randomization
Change From Baseline in Quality-of-Life Score
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, version 3.0 (EORTC QLQ-C30 v3.0), together with the lung cancer-specific module (EORTC QLQ-LC13). Scores for each scale and single-item measure are linearly transformed to a 0-100 scale. Higher scores on the QLQ-C30 Global Health Status/Quality of Life and functional scales indicate better quality of life or functioning, whereas higher scores on the QLQ-C30 symptom scales and QLQ-LC13 symptom scales or items indicate greater symptom burden. No combined total score will be calculated.
Measured: Before osimertinib induction, at week 12 before randomization, and at 12 and 24 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start8 Sep 2026 (estimated)
- Primary completion1 Aug 2031 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasms, Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive 12 weeks of first-line osimertinib induction therapy before randomization. Participants with partial response or stable disease who remain eligible for surgery will be randomized in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib.
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Statistical Center, NTUHCTC, National Taiwan University Hospital
- Investigators
- Chong-Jen Yu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738172
- Sponsor's protocol ID
- 202605130RINE
- Acronym
- PTR-2
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical approvals, institutional policies, data-use agreements, and protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy
- ClinicalTrials.gov ID
- NCT07738172
- Acronym / sponsor ID
- PTR-2 / 202605130RINE
- Keywords
- non-small cell lung cancer (NSCLC), EGFR mutation, stage IV non-small-cell lung cancer, Osimertinib, Primary tumor resection, Oligometastatic non-small cell lung cancer, Local consolidative therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2031 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 31 Jul 2026 (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.
Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.
This multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.
All participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.
Detailed description
This is a multicenter, open-label, parallel-group, randomized controlled phase III trial evaluating primary lung tumor resection in patients with EGFR-mutated oligometastatic stage IV non-small cell lung cancer treated with first-line osimertinib.
The study includes two eligibility assessments. During the first assessment, participants must have histologically or cytologically confirmed stage IV non-small cell lung cancer harboring an EGFR exon 19 deletion or exon 21 L858R mutation, a dominant and potentially resectable primary lung tumor, no more than three involved organs, and no more than 10 distant metastatic lesions.
All enrolled participants will receive protocol-defined induction treatment with osimertinib 80 mg orally once daily for 12 weeks. After induction, participants will undergo restaging. Only participants with partial response or stable disease according to RECIST version 1.1 who remain medically and technically suitable for primary lung tumor resection will undergo randomization.
Eligible participants will be randomly assigned in a 1:1 ratio to one of two groups:
- Osimertinib alone; or
- Primary lung tumor resection followed by continued osimertinib. Randomization will be stratified by EGFR mutation subtype, presence of brain metastases, and number of distant metastatic lesions.
Participants assigned to the surgical group will undergo therapeutic resection of the primary lung tumor after randomization. The surgical approach and extent of resection will be selected by the treating thoracic surgeon according to accepted standards of care. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate. Participants in both groups will continue osimertinib until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation.
Tumor assessments will be performed approximately every 12 weeks and evaluated according to RECIST version 1.1. Local treatment of distant metastatic lesions may be provided when clinically indicated according to standard of care and institutional practice for the PTR group, as permitted by the protocol.
The primary objective is to compare progression-free survival between the two treatment groups. Secondary and exploratory objectives include overall survival, treatment-related adverse events, pathologic response of the primary tumor, quality of life, local-regional progression-free survival, distant metastasis progression-free survival, brain metastasis progression-free survival, polymetastatic progression-free survival, systemic therapy-free survival, and exploratory molecular biomarker outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will receive 12 weeks of first-line osimertinib induction therapy before randomization. Participants with partial response or stable disease who remain eligible for surgery will be randomized in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib.
| Arm | Type | Receives |
|---|---|---|
| Osimertinib Alone | Active comparator | Drug: OsimertinibParticipants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will continue osimertinib 80 mg once daily until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation. |
| Osimertinib Plus Primary Tumor Resection | Experimental | Procedure: Primary Tumor Resection, Drug: OsimertinibParticipants will receive osimertinib 80 mg orally once daily for 12 weeks before randomization. After randomization, participants assigned to this arm will undergo therapeutic resection of the primary lung tumor. Osimertinib will generally be resumed 1 to 2 weeks after surgery when wound healing is considered adequate and will be continued until disease progression, unacceptable toxicity, withdrawal, or another protocol-defined reason for treatment discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Histologically or cytologically confirmed NSCLC.
- Age ≥18 years.
- AJCC 8th edition stage IV NSCLC.
- EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.
- WHO performance status 0-1. Patients with brain metastases must be conscious; patients with bone metastases must not have irreversible severe events such as severe pathological fracture.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Primary Tumor ResectionParticipants assigned to the experimental arm will undergo therapeutic resection of the primary lung tumor after randomization. Acceptable procedures include lobectomy, sleeve lobectomy, bilobectomy, segmentectomy, and wedge resection. The surgical approach may include video-assisted thoracic surgery or thoracotomy. Pneumonectomy and sleeve pneumonectomy are not permitted. The procedure is intended to achieve maximal regional disease control and tumor-free resection margins whenever feasible. | Procedure or surgery | Osimertinib Plus Primary Tumor Resection |
| OsimertinibOsimertinib will be administered orally at a dose of 80 mg once daily as first-line systemic therapy. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or fulfillment of other protocol-defined discontinuation criteria. Dose interruption or reduction will be permitted for treatment-related adverse events according to the study protocol. | Drug | Osimertinib Alone, Osimertinib Plus Primary Tumor Resection |
Primary outcome
Progression-Free Survival
Time frame: From randomization to disease progression or death, assessed up to 24 months after randomization.
Progression-free survival is defined as the time from randomization to the first documented occurrence of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Participants without an event will be censored at the date of their last adequate disease assessment.
4 secondary outcomes
Overall Survival
Time frame: From randomization to death from any cause, assessed up to 48 months after randomization.
Number of Participants With Treatment-Related Adverse Events
Time frame: From the first dose of osimertinib through 28 days after the last dose
Pathologic Response of the Primary Lung Tumor
Time frame: At primary lung tumor resection, generally within 12 weeks after randomization
Change From Baseline in Quality-of-Life Score
Time frame: Before osimertinib induction, at week 12 before randomization, and at 12 and 24 months after randomization.
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 9 Sep 2026.
- Individual participant dataSharing planned: Undecided. The individual participant data sharing plan has not yet been finalized. Any future sharing of de-identified participant-level data will be subject to applicable ethical approvals, institutional policies, data-use agreements, and protection of participant confidentiality.
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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.
Chong-Jen Yu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Primary Tumor Resection and Osimertinib in people with Lung Neoplasms, Non-Small Cell Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 36 inclusion and 0 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 9 Sep 2026. 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 Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Chong-Jen Yu, MD (+886-2-2322-0322, jefferycjyu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: From randomization to disease progression or death, assessed up to 24 months after randomization.). 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 Sep 2026.