NSCLCPhase 2NCT06532591
Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC
A Phase 2 study testing cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatin in people with NSCLC, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC
- What is being tested?
- cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 1 Oct 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 70 years
- Patients with non-small cell lung cancer diagnosed by pathologic histology or cytology, and the primary focus or lymph node metastasis test is clearly negative for EGFR/ALK/ROS1;
- Tumor tissue PD-L1 expression TPS <1%
- Patients with resectable stage IB (≥4 cm) to IIIB (N2) NSCLC (according to the staging criteria of the American Joint Committee on Cancer, 7th edition)
- Eastern Cooperative Oncology Group performance-status score of 0 or 1
- No previous anticancer therapy
- Patients had to have measurable disease according to the Response Evaluation Criteria in Solid Tumors, version 1.1, and pretreatment tumor tissue available to assess the expression of programmed death ligand 1 (PD-L1)
- Normal function of major organs
Who cannot join
- Patients with large cell carcinoma and mixed cell lung cancer, mixed with small cell lung cancer components;
- Presence of locally advanced unresectable or metastatic disease;
- Patients in whom imaging shows that the tumor has invaded a vital vascular perimeter or in whom, in the judgment of the investigator, there is a high likelihood that the tumor will invade a vital vessel and cause a fatal hemorrhage during the follow-up study; or patients in whom there is a significant cavitating or necrotic tumor in the lung;
- Has undergone any systemic anticancer therapy for NSCLC, including cytotoxic drug therapy, immunologic drug therapy, experimental therapy;
- Has undergone localized radiotherapy for NSCLC;
- Patients who have had a cancer other than NSCLC in the five years prior to the start of treatment in this study. Patients with cancers other than NSCLC within five years prior to the start of treatment in this study. Excluding cervical carcinoma in situ, cured basal cell carcinoma, and epithelial tumors of the bladder [including Ta and Tis];
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- Allergy to cardunculizumab or any component of the chemotherapeutic agent;
- Patients with the presence of any severe and/or uncontrolled disease
- Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy, or any active interstitial lung disease with clinical evidence;
- Patients who have had a cerebrovascular accident (including temporary ischemic attack) and pulmonary embolism within 6 months;
- Current peripheral neuropathy of ≥ CTCAE grade 2, except as a result of trauma; patients requiring total right lung resection; subjects who have had major surgery or severe trauma and whose effects of surgery or trauma have resolved less than 14 days prior to enrollment
- Patients who are participating in another clinical study or who are less than 4 weeks from the end of treatment in the previous clinical study;
- History of known severe hypersensitivity reactions to other monoclonal antibodies;
- Pregnant or lactating women;
- Previous history of definite neurologic or psychiatric disorders, including epilepsy or dementia;
- Patients who, in the judgment of the investigator, may have other factors that could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that could affect the safety of the subject or the collection of trial data and samples.
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
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, 610000
Li Juan, MD., 138 8027 6636, dr.lijuan@hotmail.com
About this study
Official title: Neoadjuvant or Adjuvant Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Plus Chemotherapy in Patients With Resectable Stage IB (≥4 cm) to IIIB(N2) PD-L1 Negative Non-small Cell Lung Cancer
The purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer
Read the detailed description
This study is design to prospectively investigate the safety and efficacy of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative NSCLC. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy.
- Conditions
- NSCLC
- Being tested
- cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatinDrug
PD-1/CTLA-4 bispecific antibody，Cadonilimab 10mg/kg IV, q3w, paclitaxel 175mg/m2 or albumin-bound paclitaxel 260mg/m2 ivgtt d1, q3w carboplatin AUC 5 ivgtt d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel +Carboplatin | Experimental | Drug:Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel+Carboplatin neoadjuvant chemotherapy[Cadonilimab, 10mg/kg ,d1,q3w; Paclitaxel 175mg/m2 ivgtt d1/Albumin-bound paclitaxel 260mg/m2,ivgtt(>30min) ,d1,q3w; carboplatin AUC 5 ivgtt d1, q3w] for 3 cycles.The patient was evaluated after 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy. Receives: Drug: cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR)
MPR is defined as the percentage of residual viable tumour cells (%RVT) in the tumour bed of no more than 10%.
Measured: At time of surgery
Secondary outcomes (4)
Pathologic complete response (pCR)
pCR is defined as no invasive and no in situ residuals in lung and nodes
Measured: At time of surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1
Measured: Up to 1 year
Event free survival at 24 months (EFS24)
EFS24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving event-free status at 24 months from diagnosis.
Measured: Up to 2 year
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion1 Oct 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.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532591
- Sponsor's protocol ID
- EK2024001
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- 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 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant or Adjuvant Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Plus Chemotherapy in Patients With Resectable Stage IB (≥4 cm) to IIIB(N2) PD-L1 Negative Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06532591
- Acronym / sponsor ID
- EK2024001
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Aug 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 purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer
Detailed description
This study is design to prospectively investigate the safety and efficacy of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative NSCLC. This is a single-institution, single-arm phase 2 clinical trial. Patients will receive 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel +Carboplatin | Experimental | Drug: cadonilimab+paclitaxel/albumin-bound paclitaxel+carboplatinDrug:Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel+Carboplatin neoadjuvant chemotherapy[Cadonilimab, 10mg/kg ,d1,q3w; Paclitaxel 175mg/m2 ivgtt d1/Albumin-bound paclitaxel 260mg/m2,ivgtt(>30min) ,d1,q3w; carboplatin AUC 5 ivgtt d1, q3w] for 3 cycles.The patient was evaluated after 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 70 years
- Patients with non-small cell lung cancer diagnosed by pathologic histology or cytology, and the primary focus or lymph node metastasis test is clearly negative for EGFR/ALK/ROS1;
- Tumor tissue PD-L1 expression TPS <1%
- Patients with resectable stage IB (≥4 cm) to IIIB (N2) NSCLC (according to the staging criteria of the American Joint Committee on Cancer, 7th edition)
- Eastern Cooperative Oncology Group performance-status score of 0 or 1
Key exclusion criteria (16 listed)
- Patients with large cell carcinoma and mixed cell lung cancer, mixed with small cell lung cancer components;
- Presence of locally advanced unresectable or metastatic disease;
- Patients in whom imaging shows that the tumor has invaded a vital vascular perimeter or in whom, in the judgment of the investigator, there is a high likelihood that the tumor will invade a vital vessel and cause a fatal hemorrhage during the follow-up study; or patients in whom there is a significant cavitating or necrotic tumor in the lung;
- Has undergone any systemic anticancer therapy for NSCLC, including cytotoxic drug therapy, immunologic drug therapy, experimental therapy;
- Has undergone localized radiotherapy for NSCLC;
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+paclitaxel/albumin-bound paclitaxel+carboplatinPD-1/CTLA-4 bispecific antibody，Cadonilimab 10mg/kg IV, q3w, paclitaxel 175mg/m2 or albumin-bound paclitaxel 260mg/m2 ivgtt d1, q3w carboplatin AUC 5 ivgtt d1, q3w | Drug | Experimental: Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel +Carboplatin |
Primary outcome
Major pathological response (MPR)
Time frame: At time of surgery
MPR is defined as the percentage of residual viable tumour cells (%RVT) in the tumour bed of no more than 10%.
4 secondary outcomes
Pathologic complete response (pCR)
Time frame: At time of surgery
Objective response rate (ORR)
Time frame: Up to 1 year
Event free survival at 24 months (EFS24)
Time frame: Up to 2 year
Treatment-Emergent Adverse Event (TEAE)
Time frame: Up to 2 year
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 20 Dec 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.
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+paclitaxel/albumin-bound paclitaxel+carboplatin in people with NSCLC, run by Sichuan Cancer Hospital and Research Institute 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 8 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: looking for participants now, as of the sponsor's last update on 20 Dec 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 Li Juan, Ph.D (138 8027 6636, dr.lijuan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) (time frame: At time of surgery). 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 20 Dec 2024.