NSCLCPhase 2ACCLAIMNCT06479759
LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing LM-108 antibody and sintilimab and LM-108 antibody and sintilimab and chemotherapy in people with NSCLC and PD-1, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LM-108 antibody and sintilimab and LM-108 antibody and sintilimab and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2024to 12 Dec 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtain written informed consent before implementing any trial-related procedures;
- Aged >= 18 years old;
- Patients with locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not candidates for surgical treatment and cannot undergo curative radiotherapy or chemotherapy according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- Absence of the following gene mutations: EGFR gene, ALK fusion oncogene, ROS1, etc. For other types of gene mutations, patients without approved targeted therapies are allowed to be included;
- Cohort 1: Patients with non-small cell lung cancer who have developed acquired resistance to PD-1 inhibitors (alone or in combination with another systemic therapy) after being responsive to treatment (for 6 months or more) can participate in this study. Cohort 2: Patients who have not received any systemic anti-tumor treatment for advanced/metastatic disease before; for patients who have previously received platinum-based adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy, or curative radiotherapy for advanced disease, disease progression occurred more than 6 months after the last treatment, they can participate in this study;
- The investigator confirms at least one measurable lesion according to RECIST 1.1 criteria;
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- Estimated life expectancy >= 3 months;
- ECOG PS: 0-1 score;
- Provide archived tumor tissue (including formalin-fixed paraffin-embedded tissue blocks containing tumor [preferred] or approximately 15 freshly cut unstained tissue sections) for confirmation of immunohistochemistry for PD-L1, CCR8, CCL1, FOXP3, etc. If archived tissue cannot be obtained, subjects must agree to undergo a tumor biopsy during the screening period;
- Hematological function is sufficient, defined as absolute neutrophil count >= 1.5×10^9 /L, platelet count >= 100×10^9 /L, hemoglobin >= 90g/L (no history of transfusion within 7 days);
- Liver function is sufficient, defined as total bilirubin level <= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels <= 2.5 times ULN for all patients, or for patients with liver metastases, AST and ALT levels <= 5 times ULN;
- Renal function is sufficient, defined as serum creatinine <= 1.5 times ULN;
- Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, INR/PT within the range specified by the anticoagulant drug is acceptable;
- Childbearing-age women must have a negative pregnancy test within 7 days before starting treatment; and reliable contraception measures (such as intrauterine devices, contraceptive pills, and condoms) should be used within 30 days of the start and end of the trial. Childbearing-age male subjects should use condoms for contraception during the trial and for 30 days after the end of the trial;
- Cooperate with regular follow-up visits and comply with the requirements of the trial.
Who cannot join
- Prior use of CCR8 drugs or other unapproved investigational drugs or treatments;
- Known history of intolerance to PD-1 inhibitor therapy;
- Receipt of any approved systemic anti-cancer therapy or systemic immunostimulant treatment within 28 days prior to the start of the study treatment;
- Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within the first 2 weeks prior to first dosing;
- History of allergic reactions to any components of the investigational drug;
- Known presence of brain metastases. Patients judged by the investigator to have stable brain metastases may be enrolled;
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- Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;
- Clinically uncontrollable pleural effusion/ascites (patients who do not require fluid drainage or have no significant increase in fluid for 3 days may be enrolled);
- Tumor compression of vital organs (such as esophagus) with associated symptoms, compression of superior vena cava, or invasion of major mediastinal vessels, heart, etc.;
- Severe comorbidities such as a history of severe pulmonary or cardiac disease, any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 3 months prior to enrollment;
- Receipt of systemic corticosteroids (> 10 mg/day prednisone or equivalent) or other systemic immunosuppressive agents (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] drugs) within 2 weeks prior to enrollment. The use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed;
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune-related hypothyroidism receiving stable doses of thyroid hormone replacement therapy are eligible to participate in this study. Patients with type 1 diabetes controlled with a stable insulin regimen are eligible to participate in this study;
- Active systemic infections, including tuberculosis (clinically diagnosed based on clinical history, physical examination, and radiological findings, as well as TB tests performed according to local medical practice), hepatitis B (known positive for HBV surface antigen [HBsAg], and HBV DNA >= 1000 cps/ml or its lower limit of reference), hepatitis C, or human immunodeficiency virus (HIV antibody positive);
- Known presence of psychiatric disorders or substance abuse that may affect compliance with trial requirements;
- Recent use of a full therapeutic dose of oral or non-oral anticoagulants or thrombolytic agents. Prophylactic use of anticoagulants is allowed;
- History, disease, treatment, or laboratory abnormalities that may interfere with trial results, hinder the subject's full participation in the study, or are deemed by the investigator to be not in the subject's best interest to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Li Wang, MD, 1817021997, leewang8023@126.com
About this study
Official title: A Multicenter Clinical Study of LM-108 Antibody in Combination With Sintilimab for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.
Read the detailed description
This study is an open-label, multi-cohort, multi-center clinical trial evaluating the efficacy, safety, and tolerability of LM-108 monoclonal antibody combined with sintilimab in treatment-naïve or previously treated subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). There are two cohorts in the study:(1)Cohort 1: NSCLC patients who developed secondary resistance after being sensitive to prior treatment with PD-1 inhibitors (monotherapy or in combination with another systemic therapy) for 6 months or more are eligible for this study.(2)Cohort 2: Patients with locally advanced or metastatic NSCLC who have not received prior systemic treatment are eligible for this study.
Subjects in Cohort 1 will receive LM-108 monoclonal antibody combined with sintilimab. Subjects in Cohort 2 will receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained, and the choice of chemotherapy regimen and the duration of use will be determined by the investigator. Treatment will continue until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other investigator-determined reasons for discontinuation, whichever occurs first, with a maximum treatment duration of 24 months. The primary study endpoint is the objective response rate (ORR) assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Being tested
- LM-108 antibody and sintilimab, LM-108 antibody and sintilimab and chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LM-108 antibody and sintilimabDrug
Also called Trial group 1
Cohort 1 receive LM-108 monoclonal antibody combined with sintilimab
LM-108 antibody and sintilimab and chemotherapyDrug
Also called Trial group 2
Cohort 2 receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 patients receive LM-108 monoclonal antibody combined with sintilimab. Receives: Drug: LM-108 antibody and sintilimab |
| Cohort 2 | Experimental | Cohort 2 patients receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained. Receives: Drug: LM-108 antibody and sintilimab and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
Measured: up to 24 months
Secondary outcomes (3)
Progression-free Survival
Progression-free survival measures the length of time during and after treatment that a patient lives with the disease without it progressing.
Measured: up to 36 months
Duration of response
Duration of response refers to the length of time during which a patient's tumor remains in remission or shows a positive response to treatment.
Measured: up to 24 months
Overall Survival
Overall survival measures the length of time from the start of treatment until death from any cause, indicating the effectiveness of the treatment in prolonging patients' lives.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start12 Jan 2024
- Primary completion12 Jun 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxia Su, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chunxia Su, Phd, Study chair, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479759
- Sponsor's protocol ID
- 2023LY0834
- Acronym
- ACCLAIM
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public article
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of LM-108 Antibody in Combination With Sintilimab for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06479759
- Acronym / sponsor ID
- ACCLAIM / 2023LY0834
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 12 Jun 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 28 Jun 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.
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients.
Detailed description
This study is an open-label, multi-cohort, multi-center clinical trial evaluating the efficacy, safety, and tolerability of LM-108 monoclonal antibody combined with sintilimab in treatment-naïve or previously treated subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). There are two cohorts in the study:(1)Cohort 1: NSCLC patients who developed secondary resistance after being sensitive to prior treatment with PD-1 inhibitors (monotherapy or in combination with another systemic therapy) for 6 months or more are eligible for this study.(2)Cohort 2: Patients with locally advanced or metastatic NSCLC who have not received prior systemic treatment are eligible for this study.
Subjects in Cohort 1 will receive LM-108 monoclonal antibody combined with sintilimab. Subjects in Cohort 2 will receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained, and the choice of chemotherapy regimen and the duration of use will be determined by the investigator. Treatment will continue until disease progression, unacceptable toxicity, initiation of a new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other investigator-determined reasons for discontinuation, whichever occurs first, with a maximum treatment duration of 24 months. The primary study endpoint is the objective response rate (ORR) assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: LM-108 antibody and sintilimabCohort 1 patients receive LM-108 monoclonal antibody combined with sintilimab. |
| Cohort 2 | Experimental | Drug: LM-108 antibody and sintilimab and chemotherapyCohort 2 patients receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Obtain written informed consent before implementing any trial-related procedures;
- Aged >= 18 years old;
- Patients with locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not candidates for surgical treatment and cannot undergo curative radiotherapy or chemotherapy according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
- Absence of the following gene mutations: EGFR gene, ALK fusion oncogene, ROS1, etc. For other types of gene mutations, patients without approved targeted therapies are allowed to be included;
- Cohort 1: Patients with non-small cell lung cancer who have developed acquired resistance to PD-1 inhibitors (alone or in combination with another systemic therapy) after being responsive to treatment (for 6 months or more) can participate in this study. Cohort 2: Patients who have not received any systemic anti-tumor treatment for advanced/metastatic disease before; for patients who have previously received platinum-based adjuvant chemo/radiotherapy, neoadjuvant chemo/radiotherapy, or curative radiotherapy for advanced disease, disease progression occurred more than 6 months after the last treatment, they can participate in this study;
Key exclusion criteria (16 listed)
- Prior use of CCR8 drugs or other unapproved investigational drugs or treatments;
- Known history of intolerance to PD-1 inhibitor therapy;
- Receipt of any approved systemic anti-cancer therapy or systemic immunostimulant treatment within 28 days prior to the start of the study treatment;
- Use of traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within the first 2 weeks prior to first dosing;
- History of allergic reactions to any components of the investigational drug;
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 |
|---|---|---|
| LM-108 antibody and sintilimabAlso: Trial group 1Cohort 1 receive LM-108 monoclonal antibody combined with sintilimab | Drug | Cohort 1 |
| LM-108 antibody and sintilimab and chemotherapyAlso: Trial group 2Cohort 2 receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles. LM-108 monoclonal antibody combined with sintilimab will be maintained | Drug | Cohort 2 |
Primary outcome
Objective response rate
Time frame: up to 24 months
Objective response rate represents the proportion of patients showing a predefined level of tumor shrinkage or disappearance in response to treatment.
3 secondary outcomes
Progression-free Survival
Time frame: up to 36 months
Duration of response
Time frame: up to 24 months
Overall Survival
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: Yes. Public article
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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.
Chunxia Su, Phd study chair
Shanghai Pulmonary Hospital, Shanghai, China
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 LM-108 antibody and sintilimab and LM-108 antibody and sintilimab and chemotherapy in people with NSCLC and PD-1, run by Shanghai Pulmonary Hospital, Shanghai, 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 15 inclusion and 16 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 28 Jun 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Wang, MD (18170211997, leewang8023@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (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 28 Jun 2024.