Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC
Recruiting
Phase 2Interventional Study
NSCLC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Sichuan Cancer Hospital and Research Institute · Other
Who this trial is looking for
This trial is looking for adults with a specific type of lung cancer that can be surgically removed. Participants will receive a treatment that combines cadonilimab and chemotherapy to see how well it works and whether it is safe.
I have been diagnosed with non-small cell lung cancer.
My tumor does not have specific gene mutations.
My tumor shows low PD-L1 expression.
I have a stage of lung cancer that can be removed by surgery.
I feel well enough to participate in the trial.
I have measurable disease that can be assessed.
I have normal function of my major organs.
You may not be able to join if
I have large cell or mixed cell lung cancer.
My cancer has spread or cannot be surgically removed.
I have had previous treatments for lung cancer.
I have had another type of cancer in the last five years.
I am allergic to cadonilimab or any chemotherapy components.
I have a serious health issue that is not under control.
I am pregnant or breastfeeding.
I have had a stroke or pulmonary embolism in the last six months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 resectabl…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 \[including Ta and Tis\];
* 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.