Non Small Cell Lung CancerPhase 2AwesomeNCT05284539
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer
A Phase 2 study testing Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.
Trial summary
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment. 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?
- Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 10 Oct 2027
- Phase
- Phase 2
- 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, Stage IV NSCLC.
- EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
- ECOG 0-1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- Presence of measurable lesions according to RECIST 1.1.
Who cannot join
- Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases.
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- General Medical Exclusions:
- Pregnant or lactating women.
- History of autoimmune disease.
Show all 13Show fewer
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive test for human immunodeficiency virus.
- Active hepatitis B or hepatitis C.
- Severe infection within 4 weeks prior to randomization.
- Significant cardiovascular disease.
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
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
Official title: Efficacy of Platinum-based Chemotherapy With or Without Immune Checkpoint Inhibitors in Patients With EGFR/ALK/ROS1 Sensitive Mutated NSCLC Who Progressed From Previous Tyrosine Kinase Inhibitors (TKI) Therapy
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
Read the detailed description
The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.
Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.
Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.
The investigators will collect the safety and efficacy data for all the patients.
The tissue and blood samples will be collected under the permission of the participate.
Single cell sequencing, DSP, RNA-seq and IHC will be performed to evaluate the TME.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
- Keywords
- EGFR, ALK, ROS1, PD-1 Blockade
- 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.
Pemetrexed, Cisplatin, Bevacizumab Plus PembrolizumabDrug
Also called Pemetrexed, Bevacizumab, Pembrolizumab, Atezolizumab
Pemetrexed, 500mg/m2, ivgtt, every 21 days. Bevacizumab 15mg/kg, ivgtt, every 21 days. Pembrolizumab, 200mg ivgtt, every 21 days. Atezolizumab, 1200mg, ivgtt, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: EGFR mutant Group | Experimental | EGFR mutant Group. Receives: Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab |
| Arm B: ALK fusion Group | Experimental | ALK fusion Group. Receives: Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab |
| Cohort C: ROS1 fusion Group. | Experimental | ROS1 fusion Group. Receives: Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab |
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 with Immune Checkpoint Inhibitor, Bevacizumab in combination with Chemotherapy 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 (3)
Objective Response Rate (ORR)
To assess PD-1 antibody, Bevacizumab in combination with Chemotherapy overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Measured: Time from first dose to last dose, or up to 24 month
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 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion10 Oct 2027 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 760 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
- NCT05284539
- Sponsor's protocol ID
- 20220117
- Acronym
- Awesome
- Status last verified
- Jun 2024
- First submitted
- 22 Jan 2022
- Last updated
- 7 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platinum-based Chemotherapy With or Without Immune Checkpoint Inhibitors in Patients With EGFR/ALK/ROS1 Sensitive Mutated NSCLC Who Progressed From Previous Tyrosine Kinase Inhibitors (TKI) Therapy
- ClinicalTrials.gov ID
- NCT05284539
- Acronym / sponsor ID
- Awesome / 20220117
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR, ALK, ROS1, PD-1 Blockade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Hunan Province Tumor HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 17 Mar 2022 (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 investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
Detailed description
The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.
Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.
Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.
The investigators will collect the safety and efficacy data for all the patients.
The tissue and blood samples will be collected under the permission of the participate.
Single cell sequencing, DSP, RNA-seq and IHC will be performed to evaluate the TME.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: EGFR mutant Group | Experimental | Drug: Pemetrexed, Cisplatin, Bevacizumab Plus PembrolizumabEGFR mutant Group. |
| Arm B: ALK fusion Group | Experimental | Drug: Pemetrexed, Cisplatin, Bevacizumab Plus PembrolizumabALK fusion Group. |
| Cohort C: ROS1 fusion Group. | Experimental | Drug: Pemetrexed, Cisplatin, Bevacizumab Plus PembrolizumabROS1 fusion Group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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, Stage IV NSCLC.
- EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
- ECOG 0-1.
Key exclusion criteria (13 listed)
- Active or untreated central nervous system metastases.
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
- Pregnant or lactating women.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
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, Cisplatin, Bevacizumab Plus PembrolizumabAlso: Pemetrexed, Bevacizumab, Pembrolizumab, AtezolizumabPemetrexed, 500mg/m2, ivgtt, every 21 days. Bevacizumab 15mg/kg, ivgtt, every 21 days. Pembrolizumab, 200mg ivgtt, every 21 days. Atezolizumab, 1200mg, ivgtt, every 21 days. | Drug | Arm A: EGFR mutant Group, Arm B: ALK fusion Group, Cohort C: ROS1 fusion Group. |
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 with Immune Checkpoint Inhibitor, Bevacizumab in combination with Chemotherapy 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
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Time from first dose to last dose, or up to 24 month
Overall survival (OS)
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
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 7 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?
A Phase 2 study testing Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab in people with 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 8 inclusion and 13 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 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 7 Jun 2024.