Non Small Cell Lung CancerPhase 2NCT06142617
A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation.
A Phase 2 study testing Pembrolizumab, pemetrexed, platinum and Osimertinib in people with Non Small Cell Lung Cancer and Immune Checkpoint Inhibitor, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Immune Checkpoint Inhibitor, EGFR Exon 21 Mutation
- What is being tested?
- Pembrolizumab, pemetrexed, platinum and Osimertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Jun 2028
- 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
- Male or female, ≥18 years old
- Primary non-squamous non-small cell lung cancer(NSCLC) with stage IV (AJCC stage,8th Edition) confirmed by cytology or histology
- Patients who have not used any anti-tumor therapy drugs such as targeted drugs, chemotherapy or immunotherapy and patients after surgery are acceptable
- EGFR exon 21 point mutation confirmed by gene test of tissue or blood and PD-L1 (22C3) TPS≥1% confirmed by immunohistochemical method
- At least one evaluable focus judged according to RECIST 1.1 standard
- Eastern Cooperative Oncology Group performance score (PS) 0 or 1
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- Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 / L, platelet count ≥ 100 × 109 / L and hemoglobin 110 ≥ 9 g / dl. Adequate renal function: serum creatinine ≤ upper limit of normal value. Adequate liver function: total bilirubin ≤ upper limit of normal value(ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)
- Life expectancy is not less than 6 months
- Male participants: Male participants must take effective contraception and do not donate sperm during the study and 180 days at least after the last dose
- Female participants can not be pregnant, breastfeeding, and meet at least one of the following conditions:
- non-fertile women or
- agree to use effective contraception during treatment and 180 days at least after the last dose
- Fertile women must perform a serum or urine pregnancy test within 72 hours before the first dose and the results must be negative (minimum sensitivity 25 IU/L or human chorionic gonadotropin (HCG) equivalent unit)
- Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)
Who cannot join
- patients who have active autoimmune disease which needs systemic treatment like disease relievers, corticosteroids, or immunosuppressants) in the last 2 years e. Alternative therapies ( such as thyroxine, insulin, and physiologic corticosteroid replacement therapy of adrenal or pituitary function insufficiency) are permitted)
- History of pneumonia (non-infectious)/interstitial lung disease which require s steroid treatment or a current pneumonia/interstitial lung disease
- Previously diagnosed immunodeficiency diseases, such as immunoglobulin deficiency, aplastic anemia
- Known history of human immunodeficiency virus (HIV) infection
- Patients who have hepatitis B (defined as hepatitis B virus (HBV) DNA > 1000 copy number) and hepatitis C virus (HCV) (defined as HCV RNA (+) infection
- Known history of active tuberculosis infection
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- Patients who received live or attenuated vaccine within 30 days prior to the first study intervention and inactivated vaccines are allowed.
- Patients who have other known malignancies within the past 1 year and needs treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative treatment, and bladder carcinoma in situ are not included.
- Patients who have symptomatic central nervous system metastases and/or meningitis
- History of hypersensitivity ( ≥ Level 3) to pembrolizumab/pemetrexed/platinum/osimertinib and/or any of its excipients
- Active infection that requires systemic treatment
- Any medical condition that the investigator believes might do harm to the patient or not in the best interest of the patients such as poorly controlled diabetes, infection requiring treatment by injection, liver failure, mental illness or any disease, treatment, laboratory abnormality that might confuse the results or interfere with the participation of patients throughout the study.
- Patients with mental illness or substance abuse which are confirmed to interfere with compliance with test requirements
- Planed or currently pregnant or lactation during the study (from beginning of the screening visit to 180 days after the last dose of the experimental drug)
- Patients who have undergone allogeneic tissue/solid organ transplantation
- Patients who could not accept regular follow-up
- Patients who are participating in or have used other investigational drugs or investigational equipment
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
Peking Union Medical College Hospital
Beijing
Yan Xu, MD, 18500296828, maraxu@163.com
About this study
Official title: A Phase II Study of Pembrolizumab Plus Platinum and Pemetrexed as First Line Therapy in Advanced Non-squamous Non-small Cell Lung Cancer Patients With EGFR Exon 21 Point Mutation and Programmed Cell Death Ligand 1 Expression
A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed cell death receptor ligand 1 (PD-L1) positive.
Read the detailed description
Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. Osimertinib will be the sequential treatment strategy at progression.
- Being tested
- Pembrolizumab, pemetrexed, platinum, Osimertinib
- 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.
Pembrolizumab, pemetrexed, platinumDrug
Also called Keytruda, pemetrexed, platinum
Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks.
OsimertinibDrug
Osimertinib will be the sequential treatment strategy at progression until resistance develops.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. Osimertinib will be the sequential treatment strategy at progression until resistance develops. Receives: Drug: Pembrolizumab, pemetrexed, platinum; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival 1 (PFS1)
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
Measured: up to 8 weeks
Secondary outcomes (4)
progression free survival 2 (PFS2)
the time length from enrollment to any of the following events: disease progression with Osimertinib or death from any cause. Disease progression will be assessed according to RECIST 1.1
Measured: up to 8weeks
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0
Measured: up to 8 weeks
objective response rate (ORR)
Proportion of patients with Complete and Partial Responses to first-line therapy.
Measured: up to 8 weeks
Life quality score
Evaluate life quality score according to Karnofsky performance status (KPS). On a scale of 10, higher scores indicate better health. A score of 0 is defined as death, on a 100-point scale, indicating normal physical fitness with no obvious symptoms and signs.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jun 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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mengzhao Wang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142617
- Sponsor's protocol ID
- K4510
- Status last verified
- Oct 2023
- First submitted
- 29 Oct 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result of the study and all the supporting information will be shared in the form of publishing article.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pembrolizumab Plus Platinum and Pemetrexed as First Line Therapy in Advanced Non-squamous Non-small Cell Lung Cancer Patients With EGFR Exon 21 Point Mutation and Programmed Cell Death Ligand 1 Expression
- ClinicalTrials.gov ID
- NCT06142617
- Acronym / sponsor ID
- K4510
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Nov 2023 (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.
A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed cell death receptor ligand 1 (PD-L1) positive.
Detailed description
Four cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. Osimertinib will be the sequential treatment strategy at progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Pembrolizumab, pemetrexed, platinum, Drug: OsimertinibFour cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. Osimertinib will be the sequential treatment strategy at progression until resistance develops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, ≥18 years old
- Primary non-squamous non-small cell lung cancer(NSCLC) with stage IV (AJCC stage,8th Edition) confirmed by cytology or histology
- Patients who have not used any anti-tumor therapy drugs such as targeted drugs, chemotherapy or immunotherapy and patients after surgery are acceptable
- EGFR exon 21 point mutation confirmed by gene test of tissue or blood and PD-L1 (22C3) TPS≥1% confirmed by immunohistochemical method
- At least one evaluable focus judged according to RECIST 1.1 standard
Key exclusion criteria (17 listed)
- patients who have active autoimmune disease which needs systemic treatment like disease relievers, corticosteroids, or immunosuppressants) in the last 2 years e. Alternative therapies ( such as thyroxine, insulin, and physiologic corticosteroid replacement therapy of adrenal or pituitary function insufficiency) are permitted)
- History of pneumonia (non-infectious)/interstitial lung disease which require s steroid treatment or a current pneumonia/interstitial lung disease
- Previously diagnosed immunodeficiency diseases, such as immunoglobulin deficiency, aplastic anemia
- Known history of human immunodeficiency virus (HIV) infection
- Patients who have hepatitis B (defined as hepatitis B virus (HBV) DNA > 1000 copy number) and hepatitis C virus (HCV) (defined as HCV RNA (+) infection
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 |
|---|---|---|
| Pembrolizumab, pemetrexed, platinumAlso: Keytruda, pemetrexed, platinumFour cycles of platinum and pemetrexed in combination with pembrolizumab will be administered as first line therapy and up to 31 cycles pemetrexed and pembrolizumab maintenance therapy every 3 weeks. | Drug | experimental group |
| OsimertinibOsimertinib will be the sequential treatment strategy at progression until resistance develops. | Drug | experimental group |
Primary outcome
progression free survival 1 (PFS1)
Time frame: up to 8 weeks
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
4 secondary outcomes
progression free survival 2 (PFS2)
Time frame: up to 8weeks
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: up to 8 weeks
objective response rate (ORR)
Time frame: up to 8 weeks
Life quality score
Time frame: up to 8 weeks
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 21 Nov 2023.
- Individual participant dataSharing planned: No. The result of the study and all the supporting information will be shared in the form of publishing article.
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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.
Mengzhao Wang, MD principal investigator
Peking Union Medical College 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 Pembrolizumab, pemetrexed, platinum and Osimertinib in people with Non Small Cell Lung Cancer and Immune Checkpoint Inhibitor, run by Peking Union Medical College 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 14 inclusion and 17 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: opening soon, as of the sponsor's last update on 21 Nov 2023. 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 Mengzhao Wang, MD (+8613911235467, mengzhaowang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival 1 (PFS1) (time frame: up to 8 weeks). 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 21 Nov 2023.