Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer (CREATE)

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.

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Immune checkpoint inhibitor

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Yongchang Zhang, MD; Phone Number: 7+861383123436 +8613873123436; Email: zhangyongchang@csu.edu.cn
• Study Contact Backup: Name: Nong Yang, MD; Phone Number: +8613873123436 +8613873123436; Email: yangnong0217@163.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Yongchang Zhang, MD; Phone Number: +86 731 89762323; Email: zhangyongchang@csu.edu.cn
      • Contact: Nong Yang, MD; Phone Number: +86 731 89762321; Email: yangnong0217@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Description

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.

Exclusion Criteria:

Patients did not match for the Inclusion Criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

12

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort B; Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
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; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort D; Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
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; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort F; Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort G; Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort H; Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
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; Chemotherapy follow the guild line.; Other Names: Chemotherapy
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; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort K; Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy
Cohort L; Non-small cell Lung Cancer who enrolled in clinical trials.	Drug: Immune checkpoint inhibitor; Chemotherapy follow the guild line.; Other Names: Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs) according to CTCAE 5.0	Number of participants with adverse events (AEs) according to CTCAE 5.0	From first dose until 28 days after the last dose, up to 24 month
Overall survival (OS)	To assess overall survival, define as first dose to the death of the subject due to any cause	Time from first subject dose to study completion, or up to 36 months.
Objective Response Rate (ORR)	To assess ICI and TKIs overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	Time from first subject dose to study completion, or up to 36 months.
Duration of Response (DOR)	To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death	Time from first subject dose to study completion, or up to 36 month
Patient reported outcome	Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status.	Time from first subject dose to study completion, or up to 36 months.

Collaborators and Investigators

• Sponsor: Hunan Province Tumor Hospital
• Investigators: Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2021
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Chemotherapy, Immune Checkpoint Inhibitors
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors
• Other Study ID Numbers: 20210113 (Amgen)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No