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

June 1, 2024 updated by: Yongchang Zhang, Hunan Province Tumor Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Time from first subject dose to study completion, or up to 36 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events (AEs) according to CTCAE 5.0
Time Frame: From first dose until 28 days after the last dose, up to 24 month
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)
Time Frame: Time from first subject dose to study completion, or up to 36 months.
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)
Time Frame: Time from first subject dose to study completion, or up to 36 months.
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)
Time Frame: Time from first subject dose to study completion, or up to 36 month
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
Time Frame: Time from first subject dose to study completion, or up to 36 months.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hunan Province Tumor Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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