Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer Stages IIB-IIIB

NCT ID: NCT04197076

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2024-12-31

Brief Summary

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）

Detailed Description

This is an open, observational clinical study, 2-3 cycles treatment will be planned as neo-adjuvant therapy for NSCLC participants in stage IIB-IIIB.

Study design:

Newly diagnosed Resectable IIB-IIIB NSCLC EGFR/ALK/ROS1 TEST PD-L1 TEST Collect puncture biopsy tissue/ Blood sample in screening period Chest enhanced CT Conditions allowed， whole body PETCT Exam; Group A：Targeted therapy Tumors with Driver genes （EGFR/ALK/ROS1 Positive） 2 cycles（42 days; Group B：Immunotherapy Enroll Patients from 816 Research treated with Neoadjuvant immunotherapy Or, treated with immunotherapy in practice（with approval） Group C：Routine Chemotherapy Driver genes（EGFR/ALK/ROS1 Negative） and PD-L1 Test negative or unknown; Operation （within 6 Ws postoperation） Standard treatment， Allow adjuvant chemotherapy±radio therapy Collect resected tissue sample(Tumor T and Node N) /Blood sample; comparisons before and after treatment: Imaging：CT、PET-CT Sample：Tumor tissue、blood

Objective and End point:

1. Main objective and end point：DFS，pCR rate

2. Second objective and end point：OS

3. Exploratory objective and end point：cRR rate、relevant AE、Change of Scoring Scale、exploration for relevant biological indicators

Conditions

Non Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neoadjuvant immunotherapy

pd-1 or pd-l1 inhabitors

anti-PD-1 or anti-PD-L1

Intervention Type: DRUG

immunotherapy anti-PD-1 or anti-PD-L1

Neoadjuvant targeted therapy

TKIs

EGFR-TKI, ALK inhibitor, ROS1 inhibitor

Intervention Type: DRUG

targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor

Neoadjuvant chemotherapy

chemotherapy

investigator decided

Intervention Type: DRUG

chemotherapy

Interventions

anti-PD-1 or anti-PD-L1

immunotherapy anti-PD-1 or anti-PD-L1

Intervention Type: DRUG

EGFR-TKI, ALK inhibitor, ROS1 inhibitor

targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor

Intervention Type: DRUG

investigator decided

chemotherapy

Intervention Type: DRUG

Other Intervention Names

Neoadjuvant immunotherapy; Neoadjuvant targeted therapy; Neoadjuvant chemotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lu Shun

Director of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shun Lu

Role: STUDY_CHAIR

Shanghai Chest Hospital

Locations

Oncology Department, Shanghai Chest Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shun D Lu

Role: CONTACT

shunlu@sjtu.edu.cn

86-21-62821990 ext. 15216769608

Yaxian Yao

Role: CONTACT

yaxianyao@hotmail.com

15216769608

Facility Contacts

Yaxian Yao

Role: primary

15216769608

References

Qi 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.

Reference Type: DERIVED

PMID: 37655106 (View on PubMed)

Gu 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.

Reference Type: DERIVED

PMID: 36059450 (View on PubMed)

Other Identifiers

Neoadjuvant study of NSCLC

Identifier Type: -

Identifier Source: org_study_id