Clinical trial · Interventional
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study
NCT04943029CI-TRIAL-00053671NEOSUNunknownPhase 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)
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by Camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage III non-small 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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Carrelizumab | Drug | Camrelizumab | ALIAS |
| Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) | Drug | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1+Chemo+surgery+PD-1
- description
- Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles.
- interventionNames
- Drug: Carrelizumab
- Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)
- Drug: Carboplatin
- Procedure: Surgery
Primary outcomes (1)
- measure
- Major pathological response (MPR) rate
- timeFrame
- 1 year
- description
- MPR rate is 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 (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent provided. * Age 18-70 when signing the consent form, both male and female; * The ECOG score is 0 or 1; * Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）; * Adequate hematological function, liver function and renal function; * Female participants should not be pregnant or breast-feeding. Exclusion Criteria: * EGFR mutation or ALK mutation was positive; * Previously received systemic anti-tumor therapy for non-small cell lung cancer; * Subjects who have received chest radiotherapy in the past; * Known human immunodeficiency virus (HIV) infection; * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * Pregnancy or breast-feeding women; * Ingredients mixed with small cell lung cancer patients.
References
Publications (0)
Data not yet available
No reference posted for this study.