Lung CancerPhase 3BECOMENCT05055908
Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors
A Phase 3 study testing Pemetrexed plus Pembrolizumab, Pembrolizumab and Pemetrexed in people with Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pemetrexed plus Pembrolizumab, Pembrolizumab and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 14 Sep 2027
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed lung cancer.
- Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
- 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Who cannot join
- Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
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
About this study
Official title: Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
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.
- Conditions
- Lung Cancer
- Being tested
- Pemetrexed plus Pembrolizumab, Pembrolizumab, Pemetrexed
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed plus PembrolizumabDrug
Also called Bevacizumab
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days
PembrolizumabDrug
Atezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc.
PemetrexedDrug
Also called Bevacizumab
Pemetrexed, 500mg/m2, ivgtt, every 21 days etc.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors | Experimental | Lung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors. Receives: Drug: Pemetrexed plus Pembrolizumab |
| Cohort B: Immune Checkpoint Inhibitors monotherapy | Experimental | Lung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy. Receives: Drug: Pembrolizumab |
| Cohort C: Chemotherapy Group. | Experimental | Lung Cancer patients treated with Chemotherapy. Receives: Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Adverse events (AEs) and gene profile
Correlation between Adverse events (AEs) and gene profile
Measured: Time from first subject dose to study completion, or up to 36 month
Secondary outcomes (2)
Adverse events (AEs) rate according to CTCAE 5.0
Adverse events (AEs) rate according to CTCAE 5.0
Measured: Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and survival outcome
Correlation between Adverse events (AEs) and survival outcome
Measured: Time from first subject dose to study completion, or up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 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
- NCT05055908
- Sponsor's protocol ID
- 20210913
- Acronym
- BECOME
- Status last verified
- Jul 2024
- First submitted
- 15 Sep 2021
- Last updated
- 2 Aug 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Biomarker Development for Lung Cancer Treated With Immune Checkpoint Inhibitors With or Without Chemotherapy
- ClinicalTrials.gov ID
- NCT05055908
- Acronym / sponsor ID
- BECOME / 20210913
- Conditions
- Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 24 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors | Experimental | Drug: Pemetrexed plus PembrolizumabLung Cancer patients treated with Chemotherapy plus Immune Checkpoint Inhibitors. |
| Cohort B: Immune Checkpoint Inhibitors monotherapy | Experimental | Drug: PembrolizumabLung Cancer patients treated with Immune Checkpoint Inhibitors monotherapy. |
| Cohort C: Chemotherapy Group. | Experimental | Drug: PemetrexedLung Cancer patients treated with Chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed lung cancer.
- Treated with Immune Checkpoint Inhibitors with or without chemotherapy.
- 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1.
Key exclusion criteria (1 listed)
- Any conditions can not match for the Inclusion Criteria, includign do not have the data to perform Adverse Events evalutation.
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 |
|---|---|---|
| Pemetrexed plus PembrolizumabAlso: BevacizumabAtezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. Pemetrexed, 500mg/m2, ivgtt, every 21 days | Drug | Cohort A: Chemotherapy plus Immune Checkpoint Inhibitors |
| PembrolizumabAtezolizumab(1200mg) ivgtt, every 21 days, or pembrolizumab, 200mg ivgtt, every 21 days etc. | Drug | Cohort B: Immune Checkpoint Inhibitors monotherapy |
| PemetrexedAlso: BevacizumabPemetrexed, 500mg/m2, ivgtt, every 21 days etc. | Drug | Cohort C: Chemotherapy Group. |
Primary outcome
Correlation between Adverse events (AEs) and gene profile
Time frame: Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and gene profile
2 secondary outcomes
Adverse events (AEs) rate according to CTCAE 5.0
Time frame: Time from first subject dose to study completion, or up to 36 month
Correlation between Adverse events (AEs) and survival outcome
Time frame: Time from first subject dose to study completion, or up to 36 month
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 2 Aug 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?
A Phase 3 study testing Pemetrexed plus Pembrolizumab, Pembrolizumab and Pemetrexed in people with 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 5 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 2 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Correlation between Adverse events (AEs) and gene profile (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 2 Aug 2024.