Non Small Cell Lung CancerCREATENCT05059951
Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Immune checkpoint inhibitor
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Oct 2021to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
Who may be able to join
- ≥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.
Who cannot join
- Patients did not match for the Inclusion Criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Yongchang Zhang, MD, +86 731 89762323, zhangyongchang@csu.edu.cn
Nong Yang, MD, +86 731 89762321, yangnong0217@163.com
About this study
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Immune checkpoint inhibitor
- Keywords
- Chemotherapy, Immune Checkpoint Inhibitors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitorDrug
Also called Chemotherapy
Chemotherapy follow the guild line.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . Receives: Drug: Immune checkpoint inhibitor | |
| Cohort B | Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . Receives: 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. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort D | Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Receives: 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. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort F | Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort G | Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort H | Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors. Receives: 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. Receives: 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. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort K | Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors. Receives: Drug: Immune checkpoint inhibitor | |
| Cohort L | Non-small cell Lung Cancer who enrolled in clinical trials. Receives: Drug: Immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes (5)
Overall survival (OS)
To assess overall survival, define as first dose to the death of the subject due to any cause
Measured: 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
Measured: 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
Measured: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Measured: From first dose until 28 days after the last dose, up to 24 month
Patient reported outcome
Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status.
Measured: Time from first subject dose to study completion, or up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start3 Oct 2021
- Primary completion15 Sep 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Province Tumor Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongchang Zhang, Hunan Province Tumor Hospital
- Investigators
- Yongchang Zhang, MD, Principal investigator, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059951
- Sponsor's protocol ID
- 20210113
- Acronym
- CREATE
- Status last verified
- Jun 2024
- First submitted
- 17 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
- ClinicalTrials.gov ID
- NCT05059951
- Acronym / sponsor ID
- CREATE / 20210113
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Chemotherapy, Immune Checkpoint Inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: Immune checkpoint inhibitorExtansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . |
| Cohort B | – | Drug: Immune checkpoint inhibitorLimit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors . |
| Cohort C | – | Drug: Immune checkpoint inhibitorSmall Celll Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort D | – | Drug: Immune checkpoint inhibitorMetastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort E | – | Drug: Immune checkpoint inhibitorMetastastic Non-small cell Lung Cancer who progressed from first line treatment and received subsequential Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort F | – | Drug: Immune checkpoint inhibitorResectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort G | – | Drug: Immune checkpoint inhibitorUnresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort H | – | Drug: Immune checkpoint inhibitorNon-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort I | – | Drug: Immune checkpoint inhibitorCohort I, Non-small cell Lung Cancer with EGFR, ALK and ROS1 sensitive mutation who received Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort J | – | Drug: Immune checkpoint inhibitorNon-small cell Lung Cancer with other oncogenic mutation including RET, BRAF etc who received Chemotherapy with or without Checkpoint Inhibitors. |
| Cohort K | – | Drug: Immune checkpoint inhibitorNon-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors. |
| Cohort L | – | Drug: Immune checkpoint inhibitorNon-small cell Lung Cancer who enrolled in clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (1 listed)
- Patients did not match for the Inclusion Criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune checkpoint inhibitorAlso: ChemotherapyChemotherapy follow the guild line. | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E, Cohort F, Cohort G, Cohort H, Cohort I, Cohort J, Cohort K, Cohort L |
Primary outcome
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
5 secondary outcomes
Overall survival (OS)
Time frame: 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.
Duration of Response (DOR)
Time frame: Time from first subject dose to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Time frame: From first dose until 28 days after the last dose, up to 24 month
Patient reported outcome
Time frame: Time from first subject dose to study completion, or up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongchang Zhang, MD principal investigator
Hunan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongchang Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from first subject dose to study completion, or up to 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.