Clinical trial · Observational
Neoadjuvant Immunotherapy in Advanced NSCLC
NCT05137912CI-TRIAL-00056355unknownClinicalTrials.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)
A number of clinical trials have demonstrated the efficacy of immunotherapy prior as neoadjuvant therapy. This study evaluates whether said neoadjuvant immunotherapy may improve improve progression free survival in NSCLC. One such example would be to evaluate either single agent or an immunotherapy combination with chemotherapy. Following this, analysis of biomarkers will be conducted to provide personalization in one's regimen.
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, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunotherapy | Biological | Immunotherapy | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Major Pathological Response
- timeFrame
- 12 Weeks
- description
- To evaluate the major pathological response (MPR) rate of participants
Secondary outcomes (3)
- measure
- Objective Response Rate
- timeFrame
- 12 Weeks
- description
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST)
- measure
- MPR based on diverse PD-L1 expression
- timeFrame
- 12 Weeks
- description
- Percentage of Participants with Major Pathologic Response Rates For Programmed Death Ligand 1 (PD-L1)-Positive Versus PD-L1-Negative Participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>= 18 Years of Age * Informed consent is provided * Histologically confirmed resectable non-small cell lung cancer with stage II-IIIA (TNM 8th edition) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Epidermal growth factor receptor (EGFR) mutation negative and anaplastic lymphoma kinase (ALK) translocation negative Exclusion Criteria: * EGFR mutation positive and ALK translocation positive * Active central nervous system (CNS) metastases * Autoimmune diseases * Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease * Patients with interstitial lung disease will not be included if they have symptomatic interstitial lung disease (ILD) - Grade 3-4 * Women who are breast feeding or pregnant * Sexually active women or men of childbearing potential who are not willing to use an effective contraceptive method during the study
References
Publications (3)
- BACKGROUNDJiang L, Huang J, Jiang S, Rong W, Shen Y, Li C, Tian Y, Ning J, Chen X, Yang Y, Ding Z, Li Z, Luo Q. The surgical perspective in neoadjuvant immunotherapy for resectable non-small cell lung cancer. Cancer Immunol Immunother. 2021 Aug;70(8):2313-2321. doi: 10.1007/s00262-021-02847-1. Epub 2021 Jan 29. PMID 33512555
- BACKGROUNDBroderick SR. Adjuvant and Neoadjuvant Immunotherapy in Non-small Cell Lung Cancer. Thorac Surg Clin. 2020 May;30(2):215-220. doi: 10.1016/j.thorsurg.2020.01.001. PMID 32327180
- BACKGROUNDGutierrez-Sainz L, Cruz-Castellanos P, Higuera O, de Castro-Carpeno J. Neoadjuvant Chemoimmunotherapy in Patients with Resectable Non-small Cell Lung Cancer. Curr Treat Options Oncol. 2021 Aug 23;22(10):91. doi: 10.1007/s11864-021-00885-6. PMID 34424417