Clinical trial · Interventional
AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small 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)
AK104, 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 AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK104 | Drug | — | UNRESOLVED |
| Albumin-Bound Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK104+albumin-bound paclitaxel+carboplatin
- description
- Participants receive 3 cycles of AK104 in combination with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy prior to surgery; followed by surgery; followed by adjuvant AK104 for 9 cycles.
- interventionNames
- Drug: AK104
- Drug: Albumin-Bound Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) Rate
- timeFrame
- At time of surgery
- description
- defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC. 3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 4. Have adequate organ function. Key Exclusion Criteria: 1. Mixed NSCLC and small cell lung cancer histology. 2. Patients with other active malignancies within 3 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5. Presence of other uncontrolled serious medical conditions.
References
Publications (0)
Data not yet available