NSCLC (Non-small Cell Lung Carcinoma)Phase 2NCT07314216
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma
A Phase 2 study testing Firmonertinib and Definitive Thoracic Radiotherapy in people with NSCLC (Non-small Cell Lung Carcinoma) and Stage III, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Non-small Cell Lung Carcinoma), Stage III, EGFR Uncommon Mutations
- What is being tested?
- Firmonertinib and Definitive Thoracic Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2026to 31 Dec 2030
- 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
- Provision of informed consent prior to any study-specific procedures;
- Age ≥18years;
- ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer;
- Assessed as having unresectable or inoperable locally advanced non-squamous non-small cell lung cancer suitable for definitive radiotherapy (Stage III according to AJCC 9th edition TNM staging);
- Presence of EGFR uncommon mutations (excluding 19del, L858R, T790M) confirmed by genetic testing in a tertiary grade A hospital; specific types are detailed in Appendix 11;
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- No prior systemic anti-tumor therapy or radiotherapy for locally advanced non-small cell lung cancer before the first dose of the study drug, including chemotherapy, biologic therapy, targeted therapy, immunotherapy, or investigational drug therapy;
- At least one accurately measurable lesion according to RECIST 1.1, which has not been previously irradiated and was not biopsied during the screening period. If a subject has only one measurable lesion, biopsy of that lesion is permitted, provided the baseline imaging is performed at least 14 days after the biopsy;
- Female subjects must use highly effective contraception (see restrictions) for at least 2 weeks prior to the first dose, have a negative pregnancy test, must not be breastfeeding at the time of treatment initiation, OR must meet at least one of the following criteria at screening to demonstrate the absence of childbearing potential;
- Postmenopausal, defined as age over 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal treatments;
- For women aged 50 years or younger, amenorrhea for 12 months or more after cessation of exogenous hormone therapy and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the institutional postmenopausal range;
- Irreversible surgical sterilization documented by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but excluding tubal ligation;
- Male subjects must be willing to use barrier contraception ;
- Ability to comply with the study protocol and follow-up procedures, and capable of oral medication intake
Who cannot join
- Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;
- Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to the investigational drug;
- Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;
- Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive tumor volume resulting in normal tissue radiation doses exceeding dose constraints;
- NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumor;
- Prior to the first dose of the study drug, patients who have received any of the following treatments;
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- Any prior EGFR-TKI therapy;
- Patients who have received intrapleural infusion therapy; these patients may be enrolled only after pleural effusion has been stable for 28 days or more;
- Major surgery within 28 days prior to the first dose of study drug (In China, major surgery is defined according to the Level 3 and Level 4 surgeries specified in the "Administrative Measures for the Clinical Application of Medical Technologies" implemented on May 1, 2009; see Appendix 5 for details);
- Treatment with strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period (see Appendix 6 for drug list);
- Treatment with traditional Chinese medicine or Chinese patent medicine for anti-tumor indications within 7 days prior to the first dose, or patients who require continued use of these drugs during the study period;
- Concurrent use of medications known to prolong the QTc interval or that may induce Torsade de Pointes, and which require continued administration during the study period (see Appendix 8 for drug list);
- Discontinuation of other investigational drugs within less than 5 half-lives or 2 months (whichever is longer) prior to the first dose;
- Toxicities from prior anti-tumor therapy have not recovered to ≤ CTCAE Grade 1 prior to the first dose of the study drug (except for alopecia or chemotherapy-induced peripheral neuropathy ≤ CTCAE Grade 2);
- Patients with unstable pleural effusion;
- History of, or diagnosis with, another malignancy within the past 5 years, except for effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast;
- Recent active digestive tract diseases, such as duodenal ulcer, ulcerative colitis, ileitis, etc.; intestinal perforation; intestinal fistula; or other conditions deemed by the investigator as potentially leading to gastrointestinal bleeding or perforation; or refractory nausea/vomiting, chronic gastrointestinal diseases, inability to swallow the study drug, or prior extensive bowel resection that would preclude adequate absorption of firmonertinib;
- Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, active bleeding, etc., which in the investigator's judgment is not conducive to the patient's participation in the study or may compromise protocol compliance; or active infection including Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) (including any patient receiving intravenous treatment for infection; active hepatitis B infection at a minimum includes all patients serologically positive for HBsAg with HBV DNA >1000 copies/mL);
- History of interstitial lung disease (ILD), drug-induced ILD, prior history of radiation pneumonitis requiring steroid treatment, or any evidence of active ILD;
- Any known evidence of corneal lesions/damage;
- Inadequate bone marrow reserve or organ function based on examinations within 28 days prior to the first dose of study drug (without transfusion or blood products, granulocyte colony-stimulating factor, or other hematopoietic stimulators within 2 weeks prior to testing);
- Absolute neutrophil count <1.5 × 10^9/L; Platelet count <100 × 10^9/L; Hemoglobin <90 g/L;
- Alanine aminotransferase > 2.5 × ULN; Aspartate aminotransferase >2.5 × ULN; Total bilirubin > 1.5 × ULN, or for patients with liver metastases, AST and/or ALT >5 × ULN;
- Serum creatinine >1.5 × ULN, OR Creatinine clearance <50 mL/min (measured or calculated using the Cockcroft and Gault formula, see Appendix 2);
- International Normalized Ratio > 1.5, AND Activated Partial Thromboplastin Time >1.5 × ULN;
- Any of the following cardiac criteria;
- Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs, calculated using Fridericia's formula;
- Any clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG within 28 days prior to the first dose, e.g., complete left bundle branch block, third-degree, and second-degree heart block;
- Cardiac function assessment within 28 days prior to the first dose: Left Ventricular Ejection Fraction <50%; history of myocardial infarction, severe/unstable angina, or coronary artery bypass graft surgery within the past 6 months; or cardiac insufficiency ≥ NYHA Class 2;
- Pregnancy or lactation;
- Patients judged by the investigator as ineligible for the study, such as those unlikely to comply with the study protocol, procedures, and requirements; or any other circumstances warranting exclusion based on the investigator's discretion
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
Hunan Cancer Hospital
Changsha, Hunan, 410013
Huai Liu, 0731-89762321, liuhuai@hnca.org.cn
About this study
Official title: A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations
This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.
Read the detailed description
The standard treatment for patients with unresectable Stage III non-small cell lung cancer (NSCLC) is definitive concurrent chemoradiotherapy followed by consolidative immunotherapy with durvalumab. However, the efficacy of this approach remains limited. For EGFR-mutant patients, the benefit of immunotherapy is modest, highlighting the need for alternative strategies. Although the third-generation EGFR-TKI firmonertinib has become a standard first-line therapy for advanced NSCLC harboring common EGFR mutations (exon 19 deletions and L858R), patients with uncommon EGFR mutations (e.g., G719X, S768I, L861Q, and various exon 20 insertion mutations) represent a heterogeneous and understudied population. For most of these uncommon mutations, no approved targeted therapy currently exists in the setting of Stage III unresectable NSCLC.
Firmonertinib is a novel, brain-penetrant third-generation EGFR-TKI that selectively and irreversibly inhibits both EGFR-sensitizing and T790M resistance mutations. It has demonstrated significant efficacy and a manageable safety profile in patients with EGFR T790M-mutant advanced NSCLC, and has also shown promising results in the first-line treatment of common EGFR mutations. Preclinical and clinical evidence suggests that combining EGFR-TKIs with radiotherapy may yield synergistic effects. Radiotherapy induces DNA damage and alters the tumor microenvironment, potentially enhancing both local and systemic efficacy of targeted agents. This combination strategy could be superior to sequential therapy or radiotherapy alone, particularly in molecularly selected populations. This study aims to explore the potential of this targeted-radiotherapy combination as a novel, chemotherapy-sparing, curative-intent treatment paradigm for patients with Stage III, EGFR uncommon mutation-positive lung adenocarcinoma.
This is an exploratory, Phase II, single-arm study. Enrolled patients will receive the study intervention consisting of oral firmonertinib (160 mg once daily) administered continuously until disease progression, unacceptable toxicity, or other treatment discontinuation criteria are met, concurrently with definitive radiotherapy. Radiotherapy will be delivered using intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) to a total dose of 60 Gy in 30 fractions over approximately 6 weeks, with strict adherence to standard organ-at-risk dose constraints and institutional quality-assurance protocols. The primary objective is to evaluate progression-free survival (PFS). Secondary objectives include overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and exploratory analyses within specific mutation subgroups.
- Being tested
- Firmonertinib, Definitive Thoracic Radiotherapy
- Keywords
- unresectable Stage III lung adenocarcinoma, EGFR uncommon mutations, Firmonertinib, radiotherapy
- 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.
FirmonertinibDrug
Also called AST2818
Oral administration
Definitive Thoracic RadiotherapyRadiation
Also called IMRT, VMAT
Conformal radiotherapy delivered to the primary tumor and involved regional lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Firmonertinib combined with definitive radiotherapy | Experimental | Patients in this arm will receive a combined regimen of Firmonertinib targeted therapy and definitive radiotherapy. The treatment consists of three phases:
1. Induction Phase: Oral Firmonertinib monotherapy for 10-12 weeks;
2. Combined Radiotherapy Phase: Firmonertinib concurrently with definitive thoracic radiotherapy for 6-7 weeks;
3. Consolidation Phase: Firmonertinib monotherapy continued until disease progression or unacceptable toxicity. Receives: Drug: Firmonertinib; Radiation: Definitive Thoracic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
the time from the first dose of study treatment (or treatment initiation in single-arm trials) to disease progression or death from any cause, whichever occurs first.
Measured: From enrollment until 30 months after the completion of treatment
Secondary outcomes (5)
Objective response rate
Investigator-assessed objective response rate (complete response + partial response) per RECIST v1.1
Measured: From enrollment until 30 months after the completion of treatment
Disease control rate
Investigator-assessed objective response rate (complete response + partial response) per RECIST v1.1
Measured: From enrollment until 30 months after the completion of treatment
Progression-Free Survival by Mutation Type
Investigator-assessed (per RECIST v1.1) time from first study treatment to objective disease progression or death from any cause, by mutation type
Measured: From enrollment until 30 months after the completion of treatment
Overall Survival
Investigator-assessed time from the first dose of study treatment to death from any cause
Measured: From enrollment until 60 months after the completion of treatment
AE
Investigator-assessed by CTCAE 5.0
Measured: From enrollment until 30 months after the completion of treatment, every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start22 Jun 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Non-small Cell Lung Carcinoma)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huai Liu, M.Med., Principal investigator, Hunan Cancer HospitalXingxiang Pu, M.D., Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314216
- Sponsor's protocol ID
- IIT172
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations
- ClinicalTrials.gov ID
- NCT07314216
- Acronym / sponsor ID
- IIT172
- Keywords
- unresectable Stage III lung adenocarcinoma, EGFR uncommon mutations, Firmonertinib, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Jan 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.
This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.
Detailed description
The standard treatment for patients with unresectable Stage III non-small cell lung cancer (NSCLC) is definitive concurrent chemoradiotherapy followed by consolidative immunotherapy with durvalumab. However, the efficacy of this approach remains limited. For EGFR-mutant patients, the benefit of immunotherapy is modest, highlighting the need for alternative strategies. Although the third-generation EGFR-TKI firmonertinib has become a standard first-line therapy for advanced NSCLC harboring common EGFR mutations (exon 19 deletions and L858R), patients with uncommon EGFR mutations (e.g., G719X, S768I, L861Q, and various exon 20 insertion mutations) represent a heterogeneous and understudied population. For most of these uncommon mutations, no approved targeted therapy currently exists in the setting of Stage III unresectable NSCLC.
Firmonertinib is a novel, brain-penetrant third-generation EGFR-TKI that selectively and irreversibly inhibits both EGFR-sensitizing and T790M resistance mutations. It has demonstrated significant efficacy and a manageable safety profile in patients with EGFR T790M-mutant advanced NSCLC, and has also shown promising results in the first-line treatment of common EGFR mutations. Preclinical and clinical evidence suggests that combining EGFR-TKIs with radiotherapy may yield synergistic effects. Radiotherapy induces DNA damage and alters the tumor microenvironment, potentially enhancing both local and systemic efficacy of targeted agents. This combination strategy could be superior to sequential therapy or radiotherapy alone, particularly in molecularly selected populations. This study aims to explore the potential of this targeted-radiotherapy combination as a novel, chemotherapy-sparing, curative-intent treatment paradigm for patients with Stage III, EGFR uncommon mutation-positive lung adenocarcinoma.
This is an exploratory, Phase II, single-arm study. Enrolled patients will receive the study intervention consisting of oral firmonertinib (160 mg once daily) administered continuously until disease progression, unacceptable toxicity, or other treatment discontinuation criteria are met, concurrently with definitive radiotherapy. Radiotherapy will be delivered using intensity-modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT) to a total dose of 60 Gy in 30 fractions over approximately 6 weeks, with strict adherence to standard organ-at-risk dose constraints and institutional quality-assurance protocols. The primary objective is to evaluate progression-free survival (PFS). Secondary objectives include overall survival (OS), objective response rate (ORR), disease control rate (DCR), safety, and exploratory analyses within specific mutation subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firmonertinib combined with definitive radiotherapy | Experimental | Drug: Firmonertinib, Radiation: Definitive Thoracic RadiotherapyPatients in this arm will receive a combined regimen of Firmonertinib targeted therapy and definitive radiotherapy. The treatment consists of three phases: 1. Induction Phase: Oral Firmonertinib monotherapy for 10-12 weeks; 2. Combined Radiotherapy Phase: Firmonertinib concurrently with definitive thoracic radiotherapy for 6-7 weeks; 3. Consolidation Phase: Firmonertinib monotherapy continued until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Provision of informed consent prior to any study-specific procedures;
- Age ≥18years;
- ECOG performance status of 0 or 1 with no deterioration within the 2 weeks prior to enrollment, and a life expectancy of ≥12 weeks;
- Histologically or cytologically confirmed non-squamous non-small cell lung cancer;
- Assessed as having unresectable or inoperable locally advanced non-squamous non-small cell lung cancer suitable for definitive radiotherapy (Stage III according to AJCC 9th edition TNM staging);
Key exclusion criteria (31 listed)
- Pathological type is pulmonary squamous cell carcinoma or small cell lung cancer;
- Known history of hypersensitivity to the active or inactive excipients of firmonertinib, or to drugs with a similar chemical structure or class to the investigational drug;
- Confirmed presence of EGFR exon 19 deletion or exon 21 L858R mutation;
- Presence of metastatic disease, or assessed as unsuitable for definitive radiotherapy; or unable to undergo definitive radiotherapy due to extensive tumor volume resulting in normal tissue radiation doses exceeding dose constraints;
- NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumor;
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 |
|---|---|---|
| FirmonertinibAlso: AST2818Oral administration | Drug | Firmonertinib combined with definitive radiotherapy |
| Definitive Thoracic RadiotherapyAlso: IMRT, VMATConformal radiotherapy delivered to the primary tumor and involved regional lymph nodes. | Radiation | Firmonertinib combined with definitive radiotherapy |
Primary outcome
Progression-Free Survival
Time frame: From enrollment until 30 months after the completion of treatment
the time from the first dose of study treatment (or treatment initiation in single-arm trials) to disease progression or death from any cause, whichever occurs first.
5 secondary outcomes
Objective response rate
Time frame: From enrollment until 30 months after the completion of treatment
Disease control rate
Time frame: From enrollment until 30 months after the completion of treatment
Progression-Free Survival by Mutation Type
Time frame: From enrollment until 30 months after the completion of treatment
Overall Survival
Time frame: From enrollment until 60 months after the completion of treatment
AE
Time frame: From enrollment until 30 months after the completion of treatment, every 12 weeks
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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Huai Liu, M.Med. principal investigator
Hunan Cancer Hospital
Xingxiang Pu, M.D. principal investigator
Hunan Cancer 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 Firmonertinib and Definitive Thoracic Radiotherapy in people with NSCLC (Non-small Cell Lung Carcinoma) and Stage III, run by Hunan Cancer 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 14 inclusion and 31 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 8 Jul 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 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 Huai Liu (0731-89762321, liuhuai@hnca.org.cn), 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 enrollment until 30 months after the completion of treatment). 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 8 Jul 2026.