Non-small Cell Lung CancerPhase 2NCT06467500
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
A Phase 2 study testing Cadonilimab (AK104) in people with Non-small Cell Lung Cancer, run by Xin-Hua Xu at 1 site in China.
Trial summary
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients. 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?
- Cadonilimab (AK104)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 30 Dec 2026
- 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
- Voluntarily participate in clinical research; Fully understand and be informed of this study and sign the informed consent form;
- Age ≥ 18 and ≤ 75, male or female;
- ECOG physical performance score of 0-2;
- Patients with histologically confirmed squamous or non-squamous advanced non- small cell lung cancer (according to AJCC, 8th edition);
- Patients who tested negative for driver genes after genetic testing;
- Patients who have undergone previous systemic therapy and failed anti-PD-1/PD- L1 immunotherapy;
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- Presence of at least one measurable lesion as defined by Recist criteria 1.1;
- Liver function: Total serum bilirubin ≤ 1.5 × ULN; For subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, and for those with liver metastasis, ALT and AST ≤ 5 × ULN;
- Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 45 mL/min (using the Cockcroft/Gault formula); Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 70 × 109/L; Hemoglobin ≥ 80g/L (no blood transfusion or use of hematopoietic stimulating drugs for correction within 7 days before screening) with an expected lifespan of more than 3 months.
Who cannot join
- ECOG physical performance score > 2;
- Previous treatment with bispecific antibodies;
- Participation in other clinical trials within 30 days prior to screening;
- Tumor metastasis to the brain and/or leptomeninges;
- History of other malignancies (excluding cervical carcinoma in situ or skin basal cell carcinoma that has been cured, and other malignancies that have been cured for more than 5 years);
- Accompanied by other serious diseases, including but not limited to:
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- Difficult-to-control congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled moderate to severe hypertension (SBP > 160mmHg or DBP > 100mmHg);
- Severe active infection;
- Difficult-to-control diabetes (referring to large fluctuations in blood sugar despite standard insulin therapy and frequent blood glucose monitoring, affecting the patient's life and frequently causing hypotension);
- Mental illness affecting informed consent and/or protocol compliance.
- Allergy to the drugs used in this protocol or their ingredients;
- Pregnant (confirmed by blood or urine HCG testing) or breastfeeding women, or subjects of reproductive age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last experimental treatment;
- Investigators consider it inappropriate to participate in this study;
- Unwilling to participate in this study or unable to sign the informed consent form.
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
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, 443002
Xinhua Xu, Master, +8613986747496, 2732774352@qq.com
About this study
Official title: A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driver Genes and Failed Immunotherapy
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.
Read the detailed description
Cadonilimab (AK104), China's first globally developed bispecific antibody targeting both PD-1 and CTLA-4, has demonstrated manageable safety and promising anti-tumor activity in female cervical cancer, esophageal squamous cell carcinoma, and hepatocellular carcinoma. However, there is currently no available data on the efficacy and safety of cadonilimab combined with monotherapy chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with negative driver genes and previous immunotherapy failure. Therefore, this study aims to prospectively and openly evaluate the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in treating patients with advanced NSCLC with negative driver genes and previous immunotherapy failure using a single-arm trial design. The goal is to provide a more effective and safe treatment option for these patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cadonilimab (AK104)
- 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.
Cadonilimab (AK104)Drug
Subjects participated in a study where they received cadonilimab intravenously at 6mg/kg every two weeks, prepared in 100mL of normal saline (0.9% NaCl), with a final concentration range of 0.2-5.0mg/mL. The infusion solution must be used within 4 hours of preparation. Treatment continued until disease progression (PD), unacceptable toxicity, or 24 months, whichever came first. Patients who investigators deemed could still benefit from cadonilimab post-PD were allowed continued treatment. Chemotherapy regimens were selected by investigators based on prior medication use, including gemcitabine, pemetrexed, docetaxel, albumin-bound paclitaxel, or vinorelbine as second- or third-line therapy
| Study group | Role | What they receive |
|---|---|---|
| Bispecific antibody plus Chemotherapy | Experimental | Not described Receives: Drug: Cadonilimab (AK104) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
The objective response rate (ORR) refers to the proportion of patients whose tumor shrinks by a certain percentage (generally 30%) and maintains this reduction for a certain period of time (generally 4 weeks).
Measured: approximately 24 months
Secondary outcomes (5)
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients with a cancer or tumor who experience a reduction in the size of the disease, no progression of the disease, or stable disease conditions for a specified period of time after receiving a particular treatment. This typically includes patients who achieve complete response (CR), partial response (PR), or stable disease (SD).
Measured: approximately 24 months
Duration of Response (DoR)
Duration of Response (DoR), which stands for Duration of Response, refers to the length of time from the point when a subject achieves a confirmed complete response (CR) or partial response (PR) to the time when the first sign of disease progression or death due to any cause occurs.
Measured: approximately 24 months
Progression-free survival (PFS)
PFS was defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1.
Measured: approximately 24 months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
Measured: approximately 24 months
Adverse event (AE)
Adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Measured: approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Mar 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin-Hua Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin-Hua Xu, China Three Gorges University, Yichang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467500
- Sponsor's protocol ID
- CTGU010
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driver Genes and Failed Immunotherapy
- ClinicalTrials.gov ID
- NCT06467500
- Acronym / sponsor ID
- CTGU010
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Xin-Hua XuUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 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 aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.
Detailed description
Cadonilimab (AK104), China's first globally developed bispecific antibody targeting both PD-1 and CTLA-4, has demonstrated manageable safety and promising anti-tumor activity in female cervical cancer, esophageal squamous cell carcinoma, and hepatocellular carcinoma. However, there is currently no available data on the efficacy and safety of cadonilimab combined with monotherapy chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with negative driver genes and previous immunotherapy failure. Therefore, this study aims to prospectively and openly evaluate the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in treating patients with advanced NSCLC with negative driver genes and previous immunotherapy failure using a single-arm trial design. The goal is to provide a more effective and safe treatment option for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bispecific antibody plus Chemotherapy | Experimental | Drug: Cadonilimab (AK104) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate in clinical research; Fully understand and be informed of this study and sign the informed consent form;
- Age ≥ 18 and ≤ 75, male or female;
- ECOG physical performance score of 0-2;
- Patients with histologically confirmed squamous or non-squamous advanced non- small cell lung cancer (according to AJCC, 8th edition);
- Patients who tested negative for driver genes after genetic testing;
Key exclusion criteria (14 listed)
- ECOG physical performance score > 2;
- Previous treatment with bispecific antibodies;
- Participation in other clinical trials within 30 days prior to screening;
- Tumor metastasis to the brain and/or leptomeninges;
- History of other malignancies (excluding cervical carcinoma in situ or skin basal cell carcinoma that has been cured, and other malignancies that have been cured for more than 5 years);
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 |
|---|---|---|
| Cadonilimab (AK104)Subjects participated in a study where they received cadonilimab intravenously at 6mg/kg every two weeks, prepared in 100mL of normal saline (0.9% NaCl), with a final concentration range of 0.2-5.0mg/mL. The infusion solution must be used within 4 hours of preparation. Treatment continued until disease progression (PD), unacceptable toxicity, or 24 months, whichever came first. Patients who investigators deemed could still benefit from cadonilimab post-PD were allowed continued treatment. Chemotherapy regimens were selected by investigators based on prior medication use, including gemcitabine, pemetrexed, docetaxel, albumin-bound paclitaxel, or vinorelbine as second- or third-line therapy | Drug | Bispecific antibody plus Chemotherapy |
Primary outcome
Objective Response Rate（ORR）
Time frame: approximately 24 months
The objective response rate (ORR) refers to the proportion of patients whose tumor shrinks by a certain percentage (generally 30%) and maintains this reduction for a certain period of time (generally 4 weeks).
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: approximately 24 months
Duration of Response (DoR)
Time frame: approximately 24 months
Progression-free survival (PFS)
Time frame: approximately 24 months
Overall Survival (OS)
Time frame: approximately 24 months
Adverse event (AE)
Time frame: approximately 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 21 Jun 2024.
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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 2 study testing Cadonilimab (AK104) in people with Non-small Cell Lung Cancer, run by Xin-Hua Xu 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 9 inclusion and 14 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 21 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?
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 Xinhua Xu, Master (+8613986747496, 2732774352@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate（ORR） (time frame: approximately 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 21 Jun 2024.