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RecruitingNCT05059951CREATEUpdated Jun 4, 2024

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

An observational study in Non Small Cell Lung Cancer, sponsored by Hunan Province Tumor Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.

Sponsored by Hunan Province Tumor Hospital · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Chemotherapy, Immune Checkpoint Inhibitors
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 15,000 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Hunan Province Tumor Hospital is the lead sponsor of 75 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Chemotherapy With or Without Immune Checkpoint Inhibitors for Lung Cancer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients did not match for the Inclusion Criteria.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort A

    Extansive Stage Small Cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

    Drug: Immune checkpoint inhibitor

  • Cohort B

    Limit Stage Small Celll Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors .

    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.

    Drug: Immune checkpoint inhibitor

  • Cohort D

    Metastastic Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

    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.

    Drug: Immune checkpoint inhibitor

  • Cohort F

    Resectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

    Drug: Immune checkpoint inhibitor

  • Cohort G

    Unresectable Non-small cell Lung Cancer treated with first line Chemotherapy with or without Checkpoint Inhibitors.

    Drug: Immune checkpoint inhibitor

  • Cohort H

    Non-small cell Lung Cancer received neoadjuvent or adjuvent Chemotherapy with or without Checkpoint Inhibitors.

    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.

    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.

    Drug: Immune checkpoint inhibitor

  • Cohort K

    Non-small cell Lung Cancer received Chemotherapy plus bevacizumab with or without Checkpoint Inhibitors.

    Drug: Immune checkpoint inhibitor

  • Cohort L

    Non-small cell Lung Cancer who enrolled in clinical trials.

    Drug: Immune checkpoint inhibitor

Interventions

  • DrugImmune checkpoint inhibitor

    Chemotherapy follow the guild line.

    Also known as: Chemotherapy

06

What researchers measure

Primary outcomes

  1. 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 frame: Time from first subject dose to study completion, or up to 36 month

Secondary outcomes

  1. Overall survival (OS)

    To assess overall survival, define as first dose to the death of the subject due to any cause

    Time frame: Time from first subject dose to study completion, or up to 36 months.

  2. 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 frame: Time from first subject dose to study completion, or up to 36 months.

  3. 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 frame: Time from first subject dose to study completion, or up to 36 month

  4. Adverse events (AEs) according to CTCAE 5.0

    Number of participants with adverse events (AEs) according to CTCAE 5.0

    Time frame: From first dose until 28 days after the last dose, up to 24 month

  5. Patient reported outcome

    Patient reported outcomes (PROs): A report that directly reflects a patient's assessment of their own health status.

    Time frame: Time from first subject dose to study completion, or up to 36 months.

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Sep 2026, 59 months after the start.

Of 312 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 155. This study's planned 59 months is close to that.

Counting every sponsor, half of 440 studies reached it within 56 months; a quarter within 36 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2021
First posted
Sep 28, 2021
StartActual
Oct 3, 2021
Primary completionEst.
Sep 15, 2026
CompletionEst.
Mar 1, 2028
Last update
Jun 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05059951
Lead sponsor
Hunan Province Tumor Hospital
Responsible party
Yongchang Zhang (Professor, Director of Clinical Trial Center, Hunan Province Tumor Hospital) — Principal investigator
First posted
Sep 28, 2021
Start date
Oct 3, 2021
Primary completion
Sep 15, 2026 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Jun 4, 2024

Study contacts

Yongchang Zhang, MD
Contact
zhangyongchang@csu.edu.cn
+8613873123436 ext. 7+861383123436
Nong Yang, MD
Contact
yangnong0217@163.com
+8613873123436 ext. +8613873123436
Yongchang Zhang, MD
principal investigator · Hunan Cancer Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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