Extrapulmonary Neuroendocrine CarcinomaPhase 3NCT07894211
QLC5508 vs. Investigator's Choice Chemotherapy in Advanced Extrapulmonary Neuroendocrine Carcinoma
A Phase 3 study testing Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen) and QLC5508 in people with Extrapulmonary Neuroendocrine Carcinoma, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 versus investigator's choice chemotherapy in participants with advanced EP-NEC that has failed after at least one prior platinum-based chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrapulmonary Neuroendocrine Carcinoma
- What is being tested?
- Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen) and QLC5508
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 30 Jun 2030
- 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
- Voluntarily consent to participate in this study and sign the informed consent form.
- Males and females aged ≥18 years old;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;
- Estimated survival time of more than 3 months.
- A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating; All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
- Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
Show all 11Show fewer
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0 (v6.0).
- Voluntarily sign the written informed consent form and comply with the protocol requirements.
- Histologically or cytologically confirmed advanced extrapulmonary neuroendocrine carcinoma (EP-NEC)
- Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as assessed by the investigator.
- Sufficient bone marrow and organ function.
Who cannot join
- Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
- Patients diagnosed with Merkel cell carcinoma or medullary thyroid carcinoma.
- Brain metastases (unless asymptomatic and no progression confirmed by imaging ≥4 weeks prior to randomization); Presence of leptomeningeal metastases or brainstem metastases; Spinal cord compression (identified via imaging, regardless of symptoms).
- Previous or ongoing treatment with topoisomerase I inhibitors
- Having previously received B7-H3-targeted therapy.
- Insufficient washout of prior anticancer therapies prior to randomization.
Show all 19Show fewer
- Having underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to randomization; Requiring elective surgery during the study.
- Having received live vaccine or live attenuated vaccine within 4 weeks before study randomization.
- Having received treatment with systemic corticosteroids (prednisone at >10 mg/day, or similar drugs at equivalent dose) or other immunosuppressive agents within 14 days prior to randomization.
- Moderate to severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
- Having a history of interstitial lung disease (ILD)/ non-infectious pneumonitis that required corticosteroids, current ILD/ non-infectious pneumonitis, or suspected ILD/ non-infectious pneumonitis that cannot be ruled out by imaging at screening;
- Active tuberculosis; Autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases; Having a history of allogeneic stem cell, bone marrow, or organ transplantation.
- Serious infections (e.g., bacteremia, or severe pneumonia) within 4 weeks prior to randomization; Active infection requiring systemic antibiotic therapy within 1 weeks prior to randomization;
- Having positive results in virus serology tests (hepatitis B virus infection participants receiving antiviral treatment other than interferon are allowed to be enrolled).
- Uncontrolled or significant cardiovascular disease.
- Clinically uncontrolled third-space effusion.
- Drug abuse.
- Having alcohol or drug dependence.
- Poor compliance as per investigator discretion; Any other medical conditions that may interfere with study participation or the results of the clinical study as per the discretion of investigator.
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 Randomized, Open-Label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of QLC5508 Versus Investigator's Choice Chemotherapy in Participants With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC) That Has Failed After Platinum-Containing Chemotherapy
This trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 versus investigator's choice chemotherapy in participants with advanced EP-NEC that has failed after at least one prior platinum-based chemotherapy regimen.
- Conditions
- Extrapulmonary Neuroendocrine Carcinoma
- Being tested
- Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen), QLC5508
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen)Drug
FOLFIRI regimen: Irinotecan 180 mg/m² intravenous infusion on Day 1 and Day 15, leucovorin 400 mg/m² intravenous infusion on Day 1 and Day 15, and fluorouracil 400 mg/m² intravenous push on Day 1 and Day 15, followed by fluorouracil 2400 mg/m² via continuous intravenous infusion over 46-48 hours, once every 2 weeks. Each treatment cycle is 4 weeks.
FOLFOX regimen: oxaliplatin 85 mg/m² intravenous infusion on Day 1 and Day 15, leucovorin 400 mg/m² intravenous infusion on Day 1 and Day 15, and fluorouracil 400 mg/m² intravenous push on Day 1 and Day 15, followed by fluorouracil 2400 mg/m² via continuous intravenous infusion over 46-48 hours, once every 2 weeks. Each treatment cycle is 4 weeks.
QLC5508Drug
QLC5508 will be administered intravenously once every 2 weeks. Each treatment cycle is 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| QLC5508 group | Experimental | Not described Receives: Drug: QLC5508 |
| Control group | Active comparator | Not described Receives: Drug: Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS is defined as the duration from the date of randomization to the date of death due to any cause.
Measured: Up to approximately 48 months
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the duration from the date of randomization to the date of first documented progressive disease (PD) based on investigator assessment, or death from any cause, whichever occurs first.
Measured: Up to approximately 48 months
Objective response rate (ORR)
ORR is defined as the percentage of participants achieved complete response or partial response as assessed according to RECIST v1.1 criteria.
Measured: Up to approximately 48 months
Duration of response (DOR)
DOR is defined as the duration from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Up to approximately 48 months
Disease control rate (DCR)
DCR is defined as the percentage of participants achieved complete response, partial response, or stable disease as assessed according to RECIST v1.1 criteria.
Measured: Up to approximately 48 months
Treatment Emergent Adverse Event (TEAE)
TEAEs are defined as any adverse event (AE) that occurs after the initiation of study treatment, or any pre-existing condition that worsens in severity or frequency after the initiation of study treatment, regardless of the causal relationship to the study treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.
Measured: Up to approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start26 Oct 2026 (estimated)
- Primary completion26 Mar 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrapulmonary Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894211
- Sponsor's protocol ID
- QLC5508-305
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of QLC5508 Versus Investigator's Choice Chemotherapy in Participants With Advanced Extrapulmonary Neuroendocrine Carcinoma (EP-NEC) That Has Failed After Platinum-Containing Chemotherapy
- ClinicalTrials.gov ID
- NCT07894211
- Acronym / sponsor ID
- QLC5508-305
- Conditions
- Extrapulmonary Neuroendocrine Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 26 Mar 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 26 Oct 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 trial is a Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of QLC5508 versus investigator's choice chemotherapy in participants with advanced EP-NEC that has failed after at least one prior platinum-based chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC5508 group | Experimental | Drug: QLC5508 |
| Control group | Active comparator | Drug: Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily consent to participate in this study and sign the informed consent form.
- Males and females aged ≥18 years old;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;
- Estimated survival time of more than 3 months.
- A serum pregnancy test must be performed within 7 days prior to randomization for premenopausal women of childbearing potential, and the result must be negative and must not be lactating; All enrolled patients and the partners should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
Key exclusion criteria (19 listed)
- Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
- Patients diagnosed with Merkel cell carcinoma or medullary thyroid carcinoma.
- Brain metastases (unless asymptomatic and no progression confirmed by imaging ≥4 weeks prior to randomization); Presence of leptomeningeal metastases or brainstem metastases; Spinal cord compression (identified via imaging, regardless of symptoms).
- Previous or ongoing treatment with topoisomerase I inhibitors
- Having previously received B7-H3-targeted therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen)FOLFIRI regimen: Irinotecan 180 mg/m² intravenous infusion on Day 1 and Day 15, leucovorin 400 mg/m² intravenous infusion on Day 1 and Day 15, and fluorouracil 400 mg/m² intravenous push on Day 1 and Day 15, followed by fluorouracil 2400 mg/m² via continuous intravenous infusion over 46-48 hours, once every 2 weeks. Each treatment cycle is 4 weeks. FOLFOX regimen: oxaliplatin 85 mg/m² intravenous infusion on Day 1 and Day 15, leucovorin 400 mg/m² intravenous infusion on Day 1 and Day 15, and fluorouracil 400 mg/m² intravenous push on Day 1 and Day 15, followed by fluorouracil 2400 mg/m² via continuous intravenous infusion over 46-48 hours, once every 2 weeks. Each treatment cycle is 4 weeks. | Drug | Control group |
| QLC5508QLC5508 will be administered intravenously once every 2 weeks. Each treatment cycle is 4 weeks. | Drug | QLC5508 group |
Primary outcome
Overall survival (OS)
Time frame: Up to approximately 48 months
OS is defined as the duration from the date of randomization to the date of death due to any cause.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 48 months
Objective response rate (ORR)
Time frame: Up to approximately 48 months
Duration of response (DOR)
Time frame: Up to approximately 48 months
Disease control rate (DCR)
Time frame: Up to approximately 48 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 48 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 26 Oct 2026.
Related trials for Extrapulmonary Neuroendocrine Carcinoma
RecruitingPhase 2/3
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma
RecruitingPhase 1
Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
Small Cell Lung Cancer Metastatic or Locally Advanced, Neuroendocrine Cancer
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
RecruitingPhase 1
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Previously Treated Extensive-Stage Small Cell Lung Cancer With Recurrent or Refractory Disease
Recurrent Small Cell Lung Cancer, Extensive-Stage Small Cell Lung Cancer
RecruitingPhase 3
DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy
Extrapulmonary Neuroendocrine Cancer (epNEC)
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 Phase 3 study testing Investigator's Choice Chemotherapy (FOLFIRI or FOLFOX regimen) and QLC5508 in people with Extrapulmonary Neuroendocrine Carcinoma, run by Qilu Pharmaceutical Co., Ltd..
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 11 inclusion and 19 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 26 Oct 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.
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 Hong Sun, Bachelor (+86-18106583128, hong.sun@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to approximately 48 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 26 Oct 2026.