Clinical trial · Interventional
Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients
Neoadjuvant Immunotherapy With Chemotherapy for the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase II Exploratory Study
NCT04941417CI-TRIAL-00052454unknownPhase 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)
A phase II, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with PD-(L)1 inhibitor in stage I-IIIB NSCLC adult patients followed by adjuvant PD-(L)1 inhibitor treatment for up to 1 year
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- neoadjuvant PD-(L)1 inhibitor with chemotherapy followed by PD-(L)1 inhibitor for up to 1 year
- interventionNames
- Drug: PD-1 inhibitor
Primary outcomes (1)
- measure
- MPR (major pathologic response)
- timeFrame
- Up to 8 weeks
- description
- Major pathologic response (MPR) is defined as \> 90 percent decrease in viable tumor.
Secondary outcomes (3)
- measure
- DFS(disease-free survival)
- timeFrame
- at 3 years from the first dose of neoadjuvant treatment
- description
- Time from first dose of neoadjuvant treatment to recurrence of tumor or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- 1.Histologically- or cytologically- documented NSCLC who present stage I (T≥4cm), IIA, IIB, IIIA, or IIIB disease, of either squamous or non-squamous histology. 2.Deemed surgically resectable by a thoracic surgeon 3.Age ≥ 18 years 4.Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 6.Notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines. Exclusion Criteria: * 1\. Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other mutations predicting hyperprogression of immunotherapy. 2\. Active, known or suspected autoimmune disease. 3.Other active malignancy requiring concurrent intervention or with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast). 4.Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4), or anti-PD-L1 therapeutic antibody or pathway-targeting agents 5.History of allergy to study drug components excipients
References
Publications (0)
Data not yet available
No reference posted for this study.