Non-small Cell Lung CancerNCT07418879
A Real-world Study of Pralsetinib Combined With Leucogen in the Treatment of RET Fusion-positive NSCLC
A study testing Pralsetinib and Leucogen in people with Non-small Cell Lung Cancer and RET Fusion, run by Fudan University.
Trial summary
This study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who are being treated with Pralsetinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, RET Fusion, Pralsetinib
- What is being tested?
- Pralsetinib and Leucogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- (1)Aged ≥ 18 years, male or female;
- (2)Treatment-naive patients with histopathologically confirmed locally advanced or metastatic lung adenocarcinoma that is unresectable and not eligible for curative radiotherapy;
- (3)RET fusion-positive;
- (4)Subjects with locally advanced (determined by the investigator as unsuitable for surgery or radiotherapy) or metastatic NSCLC who have not received any systemic anti-tumor treatment;
- (5)Laboratory tests indicating adequate organ function in subjects, including:a. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet Count (PLT) ≥ 100×10⁹/L; Hemoglobin (HGB) ≥ 90g/L;b. Without liver metastasis, AST and ALT ≤ 3× upper limit of normal (ULN); with liver metastasis, AST and ALT ≤ 5× ULN;c. Serum Total Bilirubin (TBIL) ≤ 1.5× ULN; for patients with Gilbert's syndrome, TBIL ≤ 3× ULN is allowed;d. Creatinine Clearance (CrCL) ≥ 40 ml/min (calculated by the Cockcroft-Gault formula);
- (6)ECOG Performance Status score of 0-2 at screening, with no significant disease progression within 2 weeks before screening;
Show all 9Show fewer
- (7)Expected survival > 12 weeks after the first dose;
- (8) Reproductive-aged female subjects are not pregnant and have no plans for pregnancy. Both reproductive-aged female and male subjects agree to use effective contraceptive measures during the study and within 6 months after drug discontinuation;
- (9) Understand and voluntarily participate in the study, and sign the informed consent form.）
Who cannot join
- (1) Histological or cytological examination indicates squamous cell-predominant non-small cell lung cancer (NSCLC), small cell lung cancer, neuroendocrine carcinoma, or other similar malignancies;
- (2) Having received the following treatments:a. Major surgery performed within 4 weeks before the first dose or planned to be performed during the trial, excluding procedures such as vascular access establishment, mediastinoscopy, or thoracoscopy-guided biopsy;b. Use of strong CYP3A4 inhibitors within 7 days before the first dose or strong CYP3A4 inducers within 21 days before the first dose; use of traditional Chinese medicines (TCMs) or TCM preparations indicated for anti-tumor therapy, or TCMs/TCM preparations with adjuvant anti-tumor effects within 2 weeks before the first dose or expected to be used during the trial;
- (3) Patients with spinal cord compression or symptomatic leptomeningeal metastasis;
- (4) Patients with symptomatic and unstable pleural effusion or ascites; those whose clinical symptoms are stable for at least 14 days after thoracentesis or paracentesis may be enrolled;
- (5) History of other malignant tumors or current concurrent other malignant tumors (excluding malignant tumors that have been cured by radical surgery and recurrence-free for 5 years, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and papillary thyroid carcinoma);
- (6) Past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment; or clinical manifestations suggestive of interstitial lung disease;
Show all 15Show fewer
- (7) Having severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (NYHA cardiac function classification III-IV), unstable angina pectoris, myocardial infarction within 1 year, active hemorrhage, and other diseases;
- (8) Resting QT interval (QTc) > 470 msec detected by clinical electrocardiogram (ECG) screening;
- (9) Clinically significant QT interval prolongation or other arrhythmias or clinical conditions that the investigator believes may increase the risk of QT interval prolongation, such as complete left bundle branch block, third-degree atrioventricular block, congenital long QT syndrome, severe hypokalemia, or concurrent use of drugs that may prolong the QT interval;
- (10) Severe gastrointestinal dysfunction or other diseases that may affect the intake, transport, or absorption of study drugs;
- (11) Patients with infectious diseases requiring intravenous medication;
- (12) Known or suspected allergy to Pralsetinib or other components of its preparation;
- (13) Female subjects who are pregnant, lactating, or planning to become pregnant during the study, or female spouses of male subjects planning to become pregnant during the study;
- (14) Subjects with poor compliance who cannot adhere to the study procedures, restrictions, or requirements;
- (15) Other conditions that the investigator deems unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-world Clinical Study of Pralsetinib in the Treatment of RET Fusion-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Prophylactic Use of Leukocyte-increasing Drug Leucogen
This study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who are being treated with Pralsetinib.
- Conditions
- Non-small Cell Lung Cancer, RET Fusion, Pralsetinib
- Being tested
- Pralsetinib, Leucogen
- 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.
PralsetinibDrug
Also called BLU-667
Pralsetinib 400mg orally once daily on an empty stomach (4 weeks as a cycle, until disease progression, death, or intolerance)
LeucogenDrug
Leucogen 20mg orally three times daily for continuous prophylactic treatment for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Pralsetinib Combined with Leucogen | Experimental | Not described Receives: Drug: Pralsetinib; Drug: Leucogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib
Metric/method of measurement:Blood samples are collected at specified time points, and indicator values are obtained through routine blood tests. The results are graded according to the CTCAE 5.0 criteria, and finally the incidence of each grade is calculated. At 1 month after the first administration of Pralsetinib. Assessed
Measured: up to 24 months
Secondary outcomes (5)
The grade and incidence of Leukopenia and neutropenia at 2 months and 3 months after the first administration of Pralsetinib
Metric/method of measurement:Blood samples are collected at specified time points, and indicator values are obtained through routine blood tests. The results are graded according to the CTCAE 5.0 criteria, and finally the incidence of each grade is calculated. At 2 months and 3 months after the first administration of Pralsetinib.
Measured: up to 24 months
Incidence of Grade 3 Treatment-Related Adverse Events (TRAE), and Incidence of Dose Interruption/Reduction/Disc continuation
The incidence of Grade 3 Treatment-Related Adverse Events (TRAE) refers to the probability of recording treatment-related adverse events that meet the Grade 3 criteria of CTCAE Version 5.0 in subjects from the first administration to 28 days after the last administration, while the incidence of dose interruption/reduction/discontinuation refers to the probability of recording corresponding events caused by drug toxicity.
Measured: up to 24 months
Time to Treatment Failure (TTF)
Time from the start of treatment to the first occurrence of a treatment failure event
Measured: up to 24 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC30)
EORTC QLQ-LC13 has 13 questions and scores range from 0-100 after a linear transformation. Negative change from baseline scores indicates less symptom severity, and thus improvement on health status.
Measured: Up to 24 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
QLQ-C30 has 30 questions and scores range from 0-100 after a linear transformation. Positive change from baseline scores on the GHS/QoL and functioning scales indicate improvement on health status/function, and negative change scores on symptom scales/items represent less symptom severity/improvement on symptom status.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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 Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418879
- Sponsor's protocol ID
- 2509-Exp284
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study of Pralsetinib in the Treatment of RET Fusion-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Prophylactic Use of Leukocyte-increasing Drug Leucogen
- ClinicalTrials.gov ID
- NCT07418879
- Acronym / sponsor ID
- 2509-Exp284
- Conditions
- Non-small Cell Lung Cancer, RET Fusion, Pralsetinib
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Feb 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 study is a single-arm, multicenter real-world clinical study designed to evaluate the safety and efficacy of Leucogen (a leukocyte-increasing agent) as a prophylactic treatment in patients with RET fusion-positive non-small cell lung cancer (NSCLC) who are being treated with Pralsetinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pralsetinib Combined with Leucogen | Experimental | Drug: Pralsetinib, Drug: Leucogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (1)Aged ≥ 18 years, male or female;
- (2)Treatment-naive patients with histopathologically confirmed locally advanced or metastatic lung adenocarcinoma that is unresectable and not eligible for curative radiotherapy;
- (3)RET fusion-positive;
- (4)Subjects with locally advanced (determined by the investigator as unsuitable for surgery or radiotherapy) or metastatic NSCLC who have not received any systemic anti-tumor treatment;
- (5)Laboratory tests indicating adequate organ function in subjects, including:a. Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet Count (PLT) ≥ 100×10⁹/L; Hemoglobin (HGB) ≥ 90g/L;b. Without liver metastasis, AST and ALT ≤ 3× upper limit of normal (ULN); with liver metastasis, AST and ALT ≤ 5× ULN;c. Serum Total Bilirubin (TBIL) ≤ 1.5× ULN; for patients with Gilbert's syndrome, TBIL ≤ 3× ULN is allowed;d. Creatinine Clearance (CrCL) ≥ 40 ml/min (calculated by the Cockcroft-Gault formula);
Key exclusion criteria (15 listed)
- (1) Histological or cytological examination indicates squamous cell-predominant non-small cell lung cancer (NSCLC), small cell lung cancer, neuroendocrine carcinoma, or other similar malignancies;
- (2) Having received the following treatments:a. Major surgery performed within 4 weeks before the first dose or planned to be performed during the trial, excluding procedures such as vascular access establishment, mediastinoscopy, or thoracoscopy-guided biopsy;b. Use of strong CYP3A4 inhibitors within 7 days before the first dose or strong CYP3A4 inducers within 21 days before the first dose; use of traditional Chinese medicines (TCMs) or TCM preparations indicated for anti-tumor therapy, or TCMs/TCM preparations with adjuvant anti-tumor effects within 2 weeks before the first dose or expected to be used during the trial;
- (3) Patients with spinal cord compression or symptomatic leptomeningeal metastasis;
- (4) Patients with symptomatic and unstable pleural effusion or ascites; those whose clinical symptoms are stable for at least 14 days after thoracentesis or paracentesis may be enrolled;
- (5) History of other malignant tumors or current concurrent other malignant tumors (excluding malignant tumors that have been cured by radical surgery and recurrence-free for 5 years, such as carcinoma in situ of the cervix, basal cell carcinoma of the skin, and papillary thyroid carcinoma);
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 |
|---|---|---|
| PralsetinibAlso: BLU-667Pralsetinib 400mg orally once daily on an empty stomach (4 weeks as a cycle, until disease progression, death, or intolerance) | Drug | Pralsetinib Combined with Leucogen |
| LeucogenLeucogen 20mg orally three times daily for continuous prophylactic treatment for 3 months | Drug | Pralsetinib Combined with Leucogen |
Primary outcome
The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib
Time frame: up to 24 months
Metric/method of measurement:Blood samples are collected at specified time points, and indicator values are obtained through routine blood tests. The results are graded according to the CTCAE 5.0 criteria, and finally the incidence of each grade is calculated. At 1 month after the first administration of Pralsetinib. Assessed
5 secondary outcomes
The grade and incidence of Leukopenia and neutropenia at 2 months and 3 months after the first administration of Pralsetinib
Time frame: up to 24 months
Incidence of Grade 3 Treatment-Related Adverse Events (TRAE), and Incidence of Dose Interruption/Reduction/Disc continuation
Time frame: up to 24 months
Time to Treatment Failure (TTF)
Time frame: up to 24 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 Items (EORTC QLQ-LC30)
Time frame: Up to 24 months
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)
Time frame: up to 24 months
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 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pralsetinib and Leucogen in people with Non-small Cell Lung Cancer and RET Fusion, run by Fudan University.
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Jialei Wang, MD (021-64175590, hatitunqiao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The grade and incidence of leukopenia and neutropenia at 1 month after the first administration of Pralsetinib (time frame: up to 24 months). 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 18 Feb 2026.