Clinical trial · Interventional
Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
An Open-label, Single-center, Phase II Study of Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab
- description
- Participants receive two cycles of Cadonilimab as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- adjuvant Cadonilimab for 6 months.
- interventionNames
- Drug: Cadonilimab
Primary outcomes (1)
- measure
- Major Pathological Response (MPR) Rate
- timeFrame
- After surgery (approximately 7 weeks)
- description
- defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy
Secondary outcomes (5)
- measure
- Pathological Complete Response (pCR) Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function. Key Exclusion Criteria: Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. Presence of other uncontrolled serious medical conditions.
References
Publications (0)
Data not yet available