Combining cadonilimab with chemotherapy for resectable PD-L1 negative lung cancer

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

This study is testing if combining a new drug called cadonilimab with chemotherapy can help people with resectable lung cancer that has low levels of PD-L1 feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (Academic / other)
• Drugs / interventions: cardunculizumab, radiation, cadonilimab, chemotherapy
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06532591 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of cadonilimab in combination with chemotherapy for patients with resectable stage IB to IIIB PD-L1 negative non-small cell lung cancer (NSCLC). Participants will undergo three cycles of neoadjuvant chemotherapy followed by surgery, with the possibility of receiving up to 12 months of adjuvant chemotherapy post-surgery. The trial is a single-institution, single-arm phase 2 clinical trial conducted at Sichuan Provincial Tumor Hospital. The focus is on patients whose tumors express low levels of PD-L1, which may respond differently to treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with resectable stage IB to IIIB PD-L1 negative NSCLC.

Not a fit: Patients with large cell carcinoma, mixed cell lung cancer, or those with locally advanced unresectable or metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with a challenging subtype of lung cancer.

How similar studies have performed: While there have been studies exploring similar combinations, this specific approach targeting PD-L1 negative NSCLC is relatively novel.

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 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.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial Tumor Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Li Juan, Ph.D

Conditions NSCLC