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RecruitingNCT05055908BECOMEUpdated Aug 2, 2024

Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors

A Phase 3 interventional study of Pemetrexed plus Pembrolizumab and Pembrolizumab in 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 2024-08-02.

Sponsored by Hunan Province Tumor Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 5 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
12,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Read the detailed description

The purpose of the study is to find some biomarkers to predict the the adverse events of Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

Step 1: All the lung cancer patients treated with Immune Checkpoint Inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study.

Step 2: All the adverse events were evaluated by principal investigator. Step 3: All the blood and FFPE samples were collected for further anaysis. Step 4: Correlation between adverse events and gene profile was analysis. Step 4: Predict model was construted with AI.

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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hunan Province Tumor Hospital is the lead sponsor of 72 studies on the registry; 47 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
  2. Age ≥ 18 years.
  3. Histologically or cytologically confirmed lung cancer.
  4. Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
  1. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.

Exclusion criteria

Exclusion Criteria:

Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12,000 participants (estimated)

Study arms

  • Experimental
    Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors

    Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors.

    Drug: Pemetrexed plus Pembrolizumab

  • Experimental
    Cohort B: Immune Checkpoint Inhibitors monotherapy

    Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy.

    Drug: Pembrolizumab

  • Experimental
    Cohort C: Chemotherapy Group.

    Lung Cancer patients treated with Chemotherapy.

    Drug: Pemetrexed

Interventions

  • DrugPemetrexed plus Pembrolizumab

    Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days

    Also known as: Bevacizumab

  • DrugPembrolizumab

    Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.

  • DrugPemetrexed

    Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.

    Also known as: Bevacizumab

06

What researchers measure

Primary outcomes

  1. Correlation between Adverse events (AEs) and gene profile

    Correlation between Adverse events (AEs) and gene profile

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

Secondary outcomes

  1. Adverse events (AEs) rate according to CTCAE 5.0

    Adverse events (AEs) rate according to CTCAE 5.0

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

  2. Correlation between Adverse events (AEs) and survival outcome

    Correlation between Adverse events (AEs) and survival outcome

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

07

Study locations

1 of 1 sites recruiting
  • Hunan Cancer Hospital
    Changsha, Hunan 410013, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05055908
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 24, 2021
Start date
Oct 1, 2021
Primary completion
Jul 1, 2025 (estimated)
Completion
Sep 14, 2027 (estimated)
Last update
Aug 2, 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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