Pancreatic CancerPhase 3NCT07079228
A Study to Compare QLS31905 and Chemotherapy With Placebo and Chemotherapy in Participants With Pancreatic Cancer
A Phase 3 study testing QLS31905, Nab-paclitaxel. and Gemcitabine in people with Pancreatic Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- QLS31905, Nab-paclitaxel. and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 602 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2025to Sep 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in the study and sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival time ≥ 3 months;
- Histologically or cytologically confirmed diagnosis of pancreatic cancer;
- No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
- At least one measurable lesion per RECIST v1.1;
- Patients with adequate cardiac, liver, renal function, etc.
Who cannot join
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- Known central nervous system metastases;
- Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
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
Beijing Cancer Hospital
Beijing
Lin Shen, M.D, 010-88196561, linshenpku@163.com
About this study
Official title: A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
- Conditions
- Pancreatic Cancer
- Being tested
- QLS31905, Nab-paclitaxel., Gemcitabine, Placebo for QLS31905
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31905Drug
QLS31905 will be administered as an IV infusion.
Nab-paclitaxel.Drug
Nab-paclitaxel will be administered as an IV infusion.
GemcitabineDrug
Gemcitabine will be administered as an IV infusion.
Placebo for QLS31905Drug
Placebo will be administered as an IV infusion.
Nab-paclitaxel.Drug
Nab-paclitaxel will be administered as an IV infusion
GemcitabineDrug
Gemcitabine will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (AG) | Experimental | Not described Receives: Drug: QLS31905; Drug: Nab-paclitaxel.; Drug: Gemcitabine |
| Placebo + nab-paclitaxel + gemcitabine (AG) | Active comparator | Not described Receives: Drug: Placebo for QLS31905; Drug: Nab-paclitaxel.; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Suryival(OS)
OS is defined as the time from randomization to deathdue to any cause.
Measured: Up to 48 months
Secondary outcomes (4)
Progression Free Survival (PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).
Measured: Up to 48 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.
Time Frame: Up to 48 months
Measured: Up to 48 months
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).
Measured: Up to 48 months
Safety assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom,or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start8 Sep 2025
- Primary completionDec 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 602 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
- NCT07079228
- Sponsor's protocol ID
- QLS31905-301
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Double-blind, Randomized Study of QLS31905 Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-Line Treatment in Participants With Claudin (CLDN)18.2-Positive Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07079228
- Acronym / sponsor ID
- QLS31905-301
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 22 Jul 2025 (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.
The goal of this study is to evaluate the efficacy of QLS31905 in combination with chemotherapy (nab-paclitaxel plus gemcitabine [AG]) versus placebo in combination with chemotherapy (AG) in the treatment of CLDN18.2-positive advanced pancreatic cancer in adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS31905 + nab-paclitaxel + gemcitabine (AG) | Experimental | Drug: QLS31905, Drug: Nab-paclitaxel., Drug: Gemcitabine |
| Placebo + nab-paclitaxel + gemcitabine (AG) | Active comparator | Drug: Placebo for QLS31905, Drug: Nab-paclitaxel., Drug: Gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily participate in the study and sign the informed consent form;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Expected survival time ≥ 3 months;
- Histologically or cytologically confirmed diagnosis of pancreatic cancer;
- No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;
Key exclusion criteria (5 listed)
- History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
- Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
- Known central nervous system metastases;
- Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test;
- Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.
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 |
|---|---|---|
| QLS31905QLS31905 will be administered as an IV infusion. | Drug | QLS31905 + nab-paclitaxel + gemcitabine (AG) |
| Nab-paclitaxel.Nab-paclitaxel will be administered as an IV infusion. | Drug | QLS31905 + nab-paclitaxel + gemcitabine (AG) |
| GemcitabineGemcitabine will be administered as an IV infusion. | Drug | QLS31905 + nab-paclitaxel + gemcitabine (AG) |
| Placebo for QLS31905Placebo will be administered as an IV infusion. | Drug | Placebo + nab-paclitaxel + gemcitabine (AG) |
| Nab-paclitaxel.Nab-paclitaxel will be administered as an IV infusion | Drug | Placebo + nab-paclitaxel + gemcitabine (AG) |
| GemcitabineGemcitabine will be administered as an IV infusion. | Drug | Placebo + nab-paclitaxel + gemcitabine (AG) |
Primary outcome
Overall Suryival(OS)
Time frame: Up to 48 months
OS is defined as the time from randomization to deathdue to any cause.
4 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 48 months
Objective Response Rate (ORR)
Time frame: Up to 48 months
Duration Of Response (DOR)
Time frame: Up to 48 months
Safety assessed by Adverse Events (AEs)
Time frame: Up to 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 23 Sep 2025.
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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.
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 QLS31905, Nab-paclitaxel. and Gemcitabine in people with Pancreatic Cancer, run by Qilu Pharmaceutical Co., Ltd. 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 7 inclusion and 5 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 23 Sep 2025. 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 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 Lin Shen, M.D (010-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Suryival(OS) (time frame: Up to 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 23 Sep 2025.