Clinical trial · Observational
Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer Stages IIB-IIIB
An Open, Observational Clinical Study, 2-3 Cycles Treatment as Neoadjuvant Therapy for NSCLC With Stage IIB-IIIB
NCT04197076CI-TRIAL-00059973unknownClinicalTrials.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 study aims to investigate the efficacy and safety of targeted therapy and chemotherapy±immunotherapy as neoadjuvant therapy in stage IIB-IIIB NSCLC patients.(observational 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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-PD-1 or anti-PD-L1 | Drug | — | UNRESOLVED |
| EGFR-TKI, ALK inhibitor, ROS1 inhibitor | Drug | — | UNRESOLVED |
| investigator decided | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Neoadjuvant immunotherapy
- description
- pd-1 or pd-l1 inhabitors
- interventionNames
- Drug: anti-PD-1 or anti-PD-L1
- label
- Neoadjuvant targeted therapy
- description
- TKIs
- interventionNames
- Drug: EGFR-TKI, ALK inhibitor, ROS1 inhibitor
- label
- Neoadjuvant chemotherapy
- description
- chemotherapy
- interventionNames
- Drug: investigator decided
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary non-small cell lung cancer confirmed by cytology or histology 2. According to the TNM stage (8th Edition) of IASLC lung cancer, it is determined to be IIB-IIIB stage non-small cell lung cancer, which is considered to be resectable; 3. There must be at least one evaluable focus judged according to recist1.1 standard (the longest diameter on spiral CT is at least 10 mm, and the longest diameter on general CT is at least 20 mm) 4. ECOG PS 0 or 1 5. There are tumor samples available for gene detection (EGFR / ALK / ros1) and PD-L1 immunohistochemistry (IHC) in the subjects, and the tumor samples should be obtained within 3 months before enrollment. 6. If all suspected mediastinal lymph nodes (including those with pathological enlargement or FDG concentration on PET / CT) can be examined by EBUS, thoracoscopy or mediastinoscopy, further sampling is required for pathological confirmation. 7. Male or female, ≥ 18 years old 8. Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl 9. Adequate liver function: total bilirubin ≤ upper limit of normal value (ULN); AST and alt ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN) 10. Adequate renal function: serum creatinine ≤ upper limit of normal value (ULN) or calculated creatinine clearance ≥ 60ml / min 11. No anti-tumor drug treatment in the past 12. For patients who have had previous surgery, it is required that more than 4 weeks have passed since the start of study treatment, and the patients have recovered 13. Women with a full uterus must have negative pregnancy test results within 28 days before entering the study (unless it is 24 months after amenorrhea). If the pregnancy test is more than 7 days from the first administration, a urine pregnancy test is required for verification (within 7 days before the first administration) 14. Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure) Exclusion Criteria: 1. Have other malignant tumors in the last 5 years 2. AST and / or ALT \> 2.5 times of the upper limit of normal value (ULN), with alkaline phosphatase \> 5 times of the upper limit of normal value (ULN) 3. Previously received radiotherapy 4. Previously used chemotherapy drugs, targeted and immunotherapy drugs (except bisphosphonates) 5. There are any uncontrolled systemic diseases, including active infection, uncontrolled hypertension, diabetes, unstable angina, congestive heart failure, myocardial infarction (within 1 year before treatment), serious arrhythmia requiring drug treatment, liver, kidney and metabolic diseases 6. Women in pregnancy or lactation 7. The patient (male or female) has the possibility of childbearing but is unwilling or does not take effective contraceptive measures 8. Receive the experimental treatment of other clinical studies at the same time (in the treatment period of clinical studies) 9. Known to be allergic to possible chemotherapy drugs 10. There is evidence of other diseases, neurological or metabolic dysfunction, abnormal physical examination or laboratory examination, and it is suspected that there may be a high risk of contraindications to the study drug or complications related to treatment
References
Publications (2)
- DERIVEDQi Y, Gu L, Shen J, Yao Y, Zhao Y, Lu S, Chen Z. An open, observational clinical study of neoadjuvant therapy in resectable stage III non-small cell lung cancer. Front Oncol. 2023 Aug 16;13:1194100. doi: 10.3389/fonc.2023.1194100. eCollection 2023. PMID 37655106
- DERIVEDGu L, Wang X, Sun Y, Xu Y, Niu X, Zhao R, Yao Y, Jian H, Han Y, Wei J, Chen Z, Lu S. An open, observational, three-arm clinical study of 2-3 cycles of treatment as neoadjuvant therapy in operable locally advanced non-small cell lung cancer: An interim analysis. Front Immunol. 2022 Aug 19;13:938269. doi: 10.3389/fimmu.2022.938269. eCollection 2022. PMID 36059450