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

Recruiting

Conditions

Intervention / Treatment

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

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

Study Contact

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

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
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)
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

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

Hunan Province Tumor Hospital

Investigators

  • 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)

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

Additional Relevant MeSH Terms

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

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.

Subscribe