Clinical trial · Interventional
Penpulimab-based Combination Neoadjuvant/Adjuvant Therapy for Patients With Resectable Locally Advanced Non-small Cell Lung Cancer: a Phase II Clinical Study (ALTER-L043)
NCT04846634CI-TRIAL-00051282ALTER-L043not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a multicenter, randomized, open label, phase II study.
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 |
|---|---|---|---|
| Resectable Locally Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Penpulimab+Anlotinib | Drug | — | UNRESOLVED |
| Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel | Drug | — | UNRESOLVED |
| Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- neoadjuvant Penpulimab + chemotherapy followed by adjuvant Penpulimab
- interventionNames
- Drug: Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
- type
- EXPERIMENTAL
- label
- neoadjuvant Penpulimab + chemotherapy + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
- interventionNames
- Drug: Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel
- type
- EXPERIMENTAL
- label
- neoadjuvant Penpulimab + Anlotinib followed by adjuvant Penpulimab + Anlotinib.
- interventionNames
- Drug: Penpulimab+Anlotinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Early stage IIB-IIIB (N2), operable non-small cell lung cancer, confirmed in tissue. * Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. * Lung function capacity capable of tolerating the proposed lung surgery. * Patients had never received surgery, chemotherapy, radiotherapy or biotherapy. Exclusion Criteria: * Large cell carcinoma and mixed cell lung cancer. * Any systemic anti-cancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, experimental treatment. * Prior treatment with local radiotherapy. * Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors). * Prior treatment with antilotinib and other antiangiogenic drugs. * History of hypersensitivity to any active or inactive ingredient of Penpulimab, Anlotinib or chemotherapy. * Patients with multiple factors affecting oral medication (e.g. inability to swallow, chronic diarrhea, and intestinal obstruction, etc.). * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease. * Patients whose tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels and cause fatal massive hemorrhage during follow-up study. * Patients who have had arteriovenous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism. * Pregnant or lactating women. * History of neurological or mental disorders, including epilepsy or dementia.
References
Publications (0)
Data not yet available
No reference posted for this study.