Non-Small Cell Lung CancerPhase 2NCT07034391
A Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
A Phase 2 study testing denosumab combined anti-PD-1 inhibitor with chemotherapy in people with Non-Small Cell Lung Cancer, run by China Medical University, China at 1 site in China.
Trial summary
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- denosumab combined anti-PD-1 inhibitor with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 31 Oct 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies
- No previous systemic therapy for advanced/metastatic disease
- At least one measurable lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- No use of parathyroid hormone/derivatives, calcitonin, osteoprotegerin, mithramycin, or potassium supplements within the past 6 months
- Adequate organ and marrow function
Who cannot join
- Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)
- Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents
- Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)
- Uncontrolled hypocalcemia or hypophosphatemia
- History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw
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
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
Zhang chief physician, 15909881516, zhangly1105@126.com
About this study
Official title: A Phase II Single-Arm Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- denosumab combined anti-PD-1 inhibitor with chemotherapy
- 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.
denosumab combined anti-PD-1 inhibitor with chemotherapyDrug
120mg of denosumab，d1 in a 28-days cycle；200mg of anti-PD-1 inhibitor, d1 in a 21-days cycle；500mg/m2 of pemetrexed, d1 in a 21-days cycle; AUC4-5 of carboplatin, d1 in a 21-days cycle, for 4-6 cycle
| Study group | Role | What they receive |
|---|---|---|
| denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor | Experimental | Not described Receives: Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month PFS rate
6-month progression-free rate
Measured: 6 months
Secondary outcomes (5)
progression-free survival（PFS）
Measured: 24 months
overall survival (OS)
Measured: 24 months
objective response rate (ORR)
Measured: 6 months
disease control rate (DCR)
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start12 May 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (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.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujuan Qu, China Medical University, China
- Investigators
- Qu chief physician, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034391
- Sponsor's protocol ID
- QL-NSCLC-LUDX-3001
- Status last verified
- Mar 2025
- First submitted
- 18 May 2025
- Last updated
- 24 Jun 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Study Evaluating the Efficacy of PD-1 Inhibitor Combined With Denosumab and Chemotherapy in Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Patients With Driver Gene-Negative Status
- ClinicalTrials.gov ID
- NCT07034391
- Acronym / sponsor ID
- QL-NSCLC-LUDX-3001
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Jun 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.
This is an interventional study to explore the efficacy and safety of denosumab combined chemotherapy and anti-PD-1/PD-L1 inhibitor in locally advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor | Experimental | Drug: denosumab combined anti-PD-1 inhibitor with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
- Documented negative for EGFR/ALK/ROS1/BRAFV600E/RET/METex14 mutations by validated genomic testing, with no prior targeted therapy and no history of other malignancies
- No previous systemic therapy for advanced/metastatic disease
- At least one measurable lesion per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Key exclusion criteria (5 listed)
- Histologically or cytologically confirmed combined small cell and non-small cell lung cancer (mixed histology)
- Any previous systemic anticancer treatment for NSCLC, including chemotherapy, biologics, immunotherapy, or investigational agents
- Prior use of denosumab or any bone-modifying agents (e.g., bisphosphonates)
- Uncontrolled hypocalcemia or hypophosphatemia
- History or current evidence of osteonecrosis of the jaw (ONJ) or osteomyelitis of the jaw
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 |
|---|---|---|
| denosumab combined anti-PD-1 inhibitor with chemotherapy120mg of denosumab，d1 in a 28-days cycle；200mg of anti-PD-1 inhibitor, d1 in a 21-days cycle；500mg/m2 of pemetrexed, d1 in a 21-days cycle; AUC4-5 of carboplatin, d1 in a 21-days cycle, for 4-6 cycle | Drug | denosumab combined chemotherapy plus anti-PD-1/PD-L1 inhibitor |
Primary outcome
6-month PFS rate
Time frame: 6 months
6-month progression-free rate
5 secondary outcomes
progression-free survival（PFS）
Time frame: 24 months
overall survival (OS)
Time frame: 24 months
objective response rate (ORR)
Time frame: 6 months
disease control rate (DCR)
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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 24 Jun 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.
Qu chief physician principal investigator
First Hospital of China Medical University
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 denosumab combined anti-PD-1 inhibitor with chemotherapy in people with Non-Small Cell Lung Cancer, run by China Medical University, China 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 24 Jun 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 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 Zhang Chief Physician (15909881516, zhangly1105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month PFS rate (time frame: 6 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 24 Jun 2025.