NSCLCPhase 2LungCadXNCT06424821
Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC
A Phase 2 study testing Cadonilimab in people with NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
Trial summary
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Cadonilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesChina
- Study dates
- 4 Jul 2023to 4 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before implementing any trial-related procedures;
- Aged 18-80 years;
- Expected survival of more than 3 months;
- The investigator confirms the presence of at least one measurable lesion according to RECIST 1.1 criteria;
- Wild-type EGFR/ALK;
- Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/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;
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- PD-L1 expression in tumor tissue with Tumor Proportion Score (TPS) < 1%;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- No prior systemic anti-tumor treatment for advanced/metastatic disease; patients who have previously received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or curative radiotherapy for advanced disease and experienced disease progression more than 6 months after the last treatment can participate in this study;
- Adequate hematologic function, defined as absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L (without transfusion history within 7 days);
- Adequate liver function, 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 in all patients, or <= 5 times ULN in patients with liver metastases;
- Adequate renal function, defined as serum creatinine <= 1.5 times ULN;
- Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; for subjects receiving anticoagulant therapy, INR/PT should be within the range planned by the anticoagulant;
- Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment, and must use reliable contraceptive measures (such as intrauterine device, contraceptive pills, and condoms) during the trial and for 30 days after the end of the trial; male subjects of reproductive potential must use condoms for contraception during the trial and for 30 days after the end of the trial;
- Willingness to comply with regular follow-up visits and trial requirements.
Who cannot join
- Currently participating in interventional clinical research treatment;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137);
- Received traditional Chinese medicine or immunomodulatory drugs (such as thymopeptide, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks prior to the first dose;
- Known allergy to the active ingredient or any excipients of Cadonilimab;
- Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;
- Uncontrolled pleural effusion/ascites clinically (patients who do not require drainage of effusion or whose effusion does not increase significantly for 3 days can be included);
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- Tumor compression of important organs (such as the esophagus) with accompanying symptoms, compression of the superior vena cava, or invasion of mediastinal large blood vessels, heart, etc.;
- History of severe complications such as severe pulmonary or cardiac disease, with 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 serious thrombotic events within 3 months prior to enrollment (thrombotic events related to implanted venous infusion ports or catheters, or superficial vein thrombosis are not considered "serious" thrombotic events);
- History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or glomerulonephritis related to antiphospholipid syndrome; Patients with stable hypothyroidism on replacement therapy with thyroid hormones are eligible to participate in this study; Patients with controlled type 1 diabetes after receiving a stable insulin treatment regimen are eligible to participate in this study;
- Received systemic corticosteroids (> 10 mg/day of 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 randomization; Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is allowed;
- Active systemic infections, including tuberculosis (TB) (clinical diagnosis based on clinical history, physical examination, radiographic findings, and TB testing according to local medical practices), hepatitis B (known positive for hepatitis B surface antigen (HBsAg) with HBV DNA >= 1,000 cps/mL or its lower limit of reference range), hepatitis C, or human immunodeficiency virus (HIV) (positive for HIV antibody);
- Known presence of mental illness or substance abuse that may affect compliance with trial requirements;
- History of conditions, diseases, treatments, or laboratory abnormalities that may interfere with trial results or hinder the subject's full participation in the study, or as determined by the investigator that participation in the study is not in the best interest of the subject.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
NINGBO No.2 Hospital
Ningbo, Zhejiang, 315016
Liangqing Nie, 15356884370
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Tianqing Chu, tianqingchu@126.com
About this study
Official title: A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.
Read the detailed description
LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel [175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS, ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces tissue for potential biomarkers study. Adverse events will be monitored throughout the trial and graded according to the CTCAE v5.0.
- Conditions
- NSCLC
- Being tested
- Cadonilimab
- Keywords
- PD-L1 negative, PD-1/CTLA-4 bispecific antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadonilimabDrug
Also called Cadonilimab group
Cadonilimab + chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel [175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC Receives: Drug: Cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression-Free Survival (PFS) rate
The 1-year Progression-Free Survival (PFS) rate refers to the proportion of patients who are alive and without disease progression one year after starting treatment.
Measured: 1 year
Secondary outcomes (4)
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 60 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 100 months
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start4 Jul 2023
- Primary completion4 Sep 2024 (estimated)
- Study completion4 Sep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 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
- NCT06424821
- Sponsor's protocol ID
- 2023LY0204
- Acronym
- LungCadX
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 22 May 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06424821
- Acronym / sponsor ID
- LungCadX / 2023LY0204
- Conditions
- NSCLC
- Keywords
- PD-L1 negative, PD-1/CTLA-4 bispecific antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 4 Sep 2024 (estimated)
- Study completion
- 4 Sep 2025 (estimated)
- First posted
- 22 May 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 PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.
Detailed description
LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel [175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS, ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces tissue for potential biomarkers study. Adverse events will be monitored throughout the trial and graded according to the CTCAE v5.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: CadonilimabCadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel [175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent must be obtained before implementing any trial-related procedures;
- Aged 18-80 years;
- Expected survival of more than 3 months;
- The investigator confirms the presence of at least one measurable lesion according to RECIST 1.1 criteria;
- Wild-type EGFR/ALK;
Key exclusion criteria (13 listed)
- Currently participating in interventional clinical research treatment;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such as CTLA-4, OX-40, CD137);
- Received traditional Chinese medicine or immunomodulatory drugs (such as thymopeptide, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks prior to the first dose;
- Known allergy to the active ingredient or any excipients of Cadonilimab;
- Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis requiring clinical intervention;
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 |
|---|---|---|
| CadonilimabAlso: Cadonilimab groupCadonilimab + chemotherapy | Drug | Trial group |
Primary outcome
1-year Progression-Free Survival (PFS) rate
Time frame: 1 year
The 1-year Progression-Free Survival (PFS) rate refers to the proportion of patients who are alive and without disease progression one year after starting treatment.
4 secondary outcomes
Progression-free Survival
Time frame: up to 60 months
Overall Survival
Time frame: up to 100 months
objective response rate
Time frame: up to 24 months
duration of response
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cadonilimab in people with NSCLC, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites 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 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (18170211997, leewang8023@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Progression-Free Survival (PFS) rate (time frame: 1 year). 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 22 May 2024.