Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

NCT ID: NCT05059951

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-03

Study Completion Date

2028-03-01

Brief Summary

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Although several clinical trials provide evidence for efficacy benefit for Checkpoint Inhibitors plus chemotherapy for lung cancer. However, there was rare evidence for clinical evidence in Hunan province.

Detailed Description

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This prospective study aimed to assess its efficacy and adverse event for Checkpoint Inhibitors with or without chemotherapy in clincial practice. Several cohorts were devided including pathological type, treatment line, treatment regiems, combination strategies. Tissue samples were collected with permission of patients for TME evaluation.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort B

Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort C

Small Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort D

Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort E

Metastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort F

Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort G

Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort H

Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort I

Cohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort J

Non-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort K

Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Cohort L

Non-small cell Lung Cancer who enrolled in clinical trials.

Immune checkpoint inhibitor

Intervention Type DRUG

Chemotherapy follow the guild line.

Interventions

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Immune checkpoint inhibitor

Chemotherapy follow the guild line.

Intervention Type DRUG

Other Intervention Names

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Chemotherapy

Eligibility Criteria

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Inclusion Criteria

1. ≥18,Lung Cancer Confirmed by Histopathology
2. Treated with Chemotherapy with or Without Checkpoint Inhibitors.
3. ECOG 0 - 1.
4. Predicted survival ≥ 12 weeks.
5. Adequate bone marrow hematopoiesis and organ function
6. Presence of measurable lesions according to RECIST 1.1.
7. Subjects with stable brain metastases may be included in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor, Director of Clinical Trial Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongchang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Hunan Cancer Hospital

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang Zhang, MD

Role: CONTACT

+8613873123436 ext. 7+861383123436

Nong Yang, MD

Role: CONTACT

+8613873123436 ext. +8613873123436

Facility Contacts

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Yongchang Zhang, MD

Role: primary

+86 731 89762323

Nong Yang, MD

Role: backup

+86 731 89762321

Other Identifiers

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20210113

Identifier Type: -

Identifier Source: org_study_id

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