Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05059951

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

Patients did not match for the Inclusion Criteria.

Treatment and study plan

Immune checkpoint inhibitor

Drug

Chemotherapy follow the guild line.

Other names: Chemotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nong Yang, MD

CONTACT

[email protected]

+8613873123436 ext. +8613873123436

Yongchang Zhang, MD

CONTACT

[email protected]

+8613873123436 ext. 7+861383123436

Sponsors and collaborators

Lead sponsor

Hunan Province Tumor Hospital

Other

Registry information

Acronym: CREATE

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Sep 28, 2021
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.