Lung CancerEarly Phase 1NCT06329908
DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs
A Early Phase 1 study testing LG002 in people with Lung Cancer, run by Zhen-Yu Ding at 1 site in China.
Trial summary
This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LG002
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2023to 31 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years.
- ECOG score was 0-2.
- Histological or cytological diagnosis confirmed non-small cell lung cancer, which was staged IIIB-IV according to AJCC version 8.
- Patients have received first-line chemotherapy combined with ICIs (PD1/PD-L1, ICIs type is not limited) and developed drug resistance.
- Normal function of major organs, that is, meeting the following criteria: a) blood routine examination (hematopoietic growth factors and blood transfusion were not used within 7 days): granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥ 80 g/L; b) biochemical examination: total bilirubin ≤ 1.5 × ULN (upper limit of normal); serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) coagulation function: INR or PT ≤ 1.5 × ULN (upper limit of normal), if the subject is receiving anticoagulant therapy, as long as PT is in the range proposed by anticoagulant drugs; d) urine routine examination: urine routine examination urine protein ≥ 2 +, 24-hour urine protein quantitative examination should be performed, such as quantitative urine protein ≤ 1 g/24 h.
- Female subjects of childbearing age or male subjects with sexual partners of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months before and after the treatment period.
- Subjects voluntarily participate in the study and sign the informed consent form
Who cannot join
- The pathological type is mixed type, containing small cell carcinoma or other types of components.
- with the blood-borne infectious disease HIV.
- History of mental disorder, drug abuse and drug abuse.
- Any other malignancy (except completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer) within 3 years.
- Accompanied by other immune diseases, or long-term use of immunosuppressive agents or hormones.
- Any unstable systemic disease (including active uncontrolled gastrointestinal ulcers, gastric obstruction, bleeding risk or coagulopathy, active infection, for subjects with hepatitis B, anti-hepatitis B 11 virus treatment is required during study treatment, active hepatitis C subjects (HCV antibody positive and HCV- RNA levels above the lower limit of detection, grade IV hypertension, unstable angina pectoris, congestive heart failure, myocarditis, unstable cerebrovascular disease, thrombotic disease, liver, kidney, uncontrolled metabolic disease or unhealed fractures, wounds as judged by the surgeon).
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- Presence of active central nervous system (CNS) metastases; subjects with previously treated brain metastases (e.g., surgery, radiotherapy, hormone therapy) are allowed if clinically stable for at least two weeks after treatment from the first dose of study drug and corticosteroids are discontinued 7 days before study drug administration; untreated, asymptomatic subjects with brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no significant edema around the brain metastases) can be enrolled.
- Any anti-tumor therapy including chemotherapy, radiotherapy, and targeted therapy within 3 weeks prior to the first dose of study drug.
- Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring drainage.
- Previous use of anti-tumor vaccines, live vaccines within 30 days.
- Patients are difficult to communicate or to follow up for a long time. Pregnant or lactating women.
- Current or planned participation in other clinical trials.
- Dr. finds other unsuitable situations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610000
Zhengyu Ding, MD, 18980601957, dingzhenyu@scu.edu.cn
Qing Li, MD, 18702848178, liqing@scu.edu.cn
About this study
Official title: Single-arm, Open, Prospective Clinical Study of Neoantigen-loaded Dendritic Cell Vaccine (Neo-DCVac) Combined With Immune Checkpoint Inhibitors (ICIs) in the Treatment of Advanced Lung Cancer Resistant to ICIs
This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.
Read the detailed description
The study screened patients with PD-1 immunochemotherapy in the first-line treatment regimen, and extracted tumor tissues from patients after PD-1 resistance for neoantigen prediction. During neoantigen screening and vaccine preparation, patients received a second-line regimen (docetaxel) as bridging therapy. After completion of bridging therapy and the patient 's vaccine preparation was successful, the patient started receiving the vaccine combined with ICIs. The completion of 5 vaccine injections was followed by an immunization course. Efficacy was assessed 2 weeks after the end of an immunization course, and if effective (tumor response evaluated as SD/PR/CR), the next cycle of immunotherapy was continued, with subsequent treatments administered every 3 weeks until disease progression or severe intolerance occurred or the patient requested withdrawal, whichever came first.
- Conditions
- Lung Cancer
- Being tested
- LG002
- Keywords
- Criteria for inclusion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG002Drug
Also called ICIs
Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.
| Study group | Role | What they receive |
|---|---|---|
| (Neo-DCVac) combined with immune checkpoint inhibitors (ICIs) | Experimental | DC cell injection ,1.5 × 10 7/time, subcutaneous multi-point injection in axilla and groin or lymph node injection guided by color Doppler ultrasound in axilla and groin, continuous injection at 0W, 1W, 3W, 5W and 7W for five times as the first immunization cycle. Tumor response was evaluated 2 weeks after the completion of the first immunotherapy cycle, and treatment was continued if the response was evaluated as effective (SD/PR/CR), and every 3 weeks until disease progression or intolerable toxicity or active withdrawal of the patient, whichever came first.ICIs are PD1/PD-L1 inhibitors and continue to be pre-enrollment ICIs of any brand Receives: Drug: LG002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of Neo-DCVac combined with ICIs.
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by" CTCAE v5.0".
Measured: 2 years
Secondary outcomes (2)
The efficacy of Neo-DCVac combined with ICIs.
Using the revisit1.1 tumor evaluation criteria for efficacy evaluation, evaluate disease progression free survival (PFS) .
Measured: 2 years
The efficacy of Neo-DCVac combined with ICIs.
Using the revisit1.1 tumor evaluation criteria for efficacy evaluation, evaluate disease objective response rate (ORR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start27 Sep 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen-Yu Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- Qing Li, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329908
- Sponsor's protocol ID
- TSLG-001
- Status last verified
- Mar 2024
- First submitted
- 28 Dec 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open, Prospective Clinical Study of Neoantigen-loaded Dendritic Cell Vaccine (Neo-DCVac) Combined With Immune Checkpoint Inhibitors (ICIs) in the Treatment of Advanced Lung Cancer Resistant to ICIs
- ClinicalTrials.gov ID
- NCT06329908
- Acronym / sponsor ID
- TSLG-001
- Conditions
- Lung Cancer
- Keywords
- Criteria for inclusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhen-Yu DingUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Mar 2024 (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 single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.
Detailed description
The study screened patients with PD-1 immunochemotherapy in the first-line treatment regimen, and extracted tumor tissues from patients after PD-1 resistance for neoantigen prediction. During neoantigen screening and vaccine preparation, patients received a second-line regimen (docetaxel) as bridging therapy. After completion of bridging therapy and the patient 's vaccine preparation was successful, the patient started receiving the vaccine combined with ICIs. The completion of 5 vaccine injections was followed by an immunization course. Efficacy was assessed 2 weeks after the end of an immunization course, and if effective (tumor response evaluated as SD/PR/CR), the next cycle of immunotherapy was continued, with subsequent treatments administered every 3 weeks until disease progression or severe intolerance occurred or the patient requested withdrawal, whichever came first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm
| Arm | Type | Receives |
|---|---|---|
| (Neo-DCVac) combined with immune checkpoint inhibitors (ICIs) | Experimental | Drug: LG002DC cell injection ,1.5 × 10 7/time, subcutaneous multi-point injection in axilla and groin or lymph node injection guided by color Doppler ultrasound in axilla and groin, continuous injection at 0W, 1W, 3W, 5W and 7W for five times as the first immunization cycle. Tumor response was evaluated 2 weeks after the completion of the first immunotherapy cycle, and treatment was continued if the response was evaluated as effective (SD/PR/CR), and every 3 weeks until disease progression or intolerable toxicity or active withdrawal of the patient, whichever came first.ICIs are PD1/PD-L1 inhibitors and continue to be pre-enrollment ICIs of any brand |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-85 years.
- ECOG score was 0-2.
- Histological or cytological diagnosis confirmed non-small cell lung cancer, which was staged IIIB-IV according to AJCC version 8.
- Patients have received first-line chemotherapy combined with ICIs (PD1/PD-L1, ICIs type is not limited) and developed drug resistance.
- Normal function of major organs, that is, meeting the following criteria: a) blood routine examination (hematopoietic growth factors and blood transfusion were not used within 7 days): granulocyte count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥ 80 g/L; b) biochemical examination: total bilirubin ≤ 1.5 × ULN (upper limit of normal); serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); c) coagulation function: INR or PT ≤ 1.5 × ULN (upper limit of normal), if the subject is receiving anticoagulant therapy, as long as PT is in the range proposed by anticoagulant drugs; d) urine routine examination: urine routine examination urine protein ≥ 2 +, 24-hour urine protein quantitative examination should be performed, such as quantitative urine protein ≤ 1 g/24 h.
Key exclusion criteria (13 listed)
- The pathological type is mixed type, containing small cell carcinoma or other types of components.
- with the blood-borne infectious disease HIV.
- History of mental disorder, drug abuse and drug abuse.
- Any other malignancy (except completely cured cervical carcinoma in situ or basal cell or squamous cell skin cancer) within 3 years.
- Accompanied by other immune diseases, or long-term use of immunosuppressive agents or hormones.
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 |
|---|---|---|
| LG002Also: ICIsNeo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs. | Drug | (Neo-DCVac) combined with immune checkpoint inhibitors (ICIs) |
Primary outcome
The safety of Neo-DCVac combined with ICIs.
Time frame: 2 years
This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by" CTCAE v5.0".
2 secondary outcomes
The efficacy of Neo-DCVac combined with ICIs.
Time frame: 2 years
The efficacy of Neo-DCVac combined with ICIs.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- 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. This study is not recruiting at the moment.
Qing Li, MD study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LG002 in people with Lung Cancer, run by Zhen-Yu Ding 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 13 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhengyu Ding, MD (18980601957, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of Neo-DCVac combined with ICIs. (time frame: 2 years). 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 Mar 2024.