Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

NCT05059951 | Recruiting

• 1 other identifier: 20210113
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Chemotherapy, Immune Checkpoint Inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To assess progression-free survival of patients treated by different treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause

  Time from first subject dose to study completion, or up to 36 month

Secondary Outcomes (5)

• Overall survival (OS)

  Time from first subject dose to study completion, or up to 36 months.

• Objective Response Rate (ORR)

  Time from first subject dose to study completion, or up to 36 months.

• Duration of Response (DOR)

  Time from first subject dose to study completion, or up to 36 month

• Adverse events (AEs) according to CTCAE 5.0

  From first dose until 28 days after the last dose, up to 24 month

• Patient reported outcome

  Time from first subject dose to study completion, or up to 36 months.

Study Arms (12)

Cohort A

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

Drug: Immune checkpoint inhibitor

Cohort B

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

Drug: Immune checkpoint inhibitor

Cohort C

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

Drug: Immune checkpoint inhibitor

Cohort D

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

Drug: Immune checkpoint inhibitor

Cohort E

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

Drug: Immune checkpoint inhibitor

Cohort F

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

Drug: Immune checkpoint inhibitor

Cohort G

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

Drug: Immune checkpoint inhibitor

Cohort H

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

Drug: Immune checkpoint inhibitor

Cohort I

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

Drug: Immune checkpoint inhibitor

Cohort J

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

Drug: Immune checkpoint inhibitor

Cohort K

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

Drug: Immune checkpoint inhibitor

Cohort L

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

Drug: Immune checkpoint inhibitor

Interventions

Immune checkpoint inhibitor DRUG

Chemotherapy follow the guild line.

Also known as: Chemotherapy

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E; Cohort F; Cohort G; Cohort H; Cohort I; Cohort J; Cohort K; Cohort L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

You may qualify if:

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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tissue sample and plasma DNA was obtained with the permission of patients.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immune Checkpoint Inhibitors; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Trial Center

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: October 3, 2021
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)