Non-small-lung-cell CancerNCT04552613
Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients
A study testing EGFR-TKI and EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin) in people with Non-small-lung-cell Cancer and NSCLC, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This study is a randomized, multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small cell lung cancer, NSCLC) with concurrent Driver gene mutations，who used EGFR-TKI with or without combined chemotherapy，estimated with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-small-lung-cell Cancer, NSCLC, EGFR Gene Mutation
- What is being tested?
- EGFR-TKI and EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2020to 24 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures.
- 18 to 80 years old (with critical values) when signing ICF.
- Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy.
- Patients have never received systemic treatment throughout the body for phase IIIB or IV NSCLC(Neoadjuvant or adjuvant chemotherapy is excluded).
- Known EGFR sensitivity mutations with concurrent other Driver gene mutations, such as T790M，TP53，RB1，PTEN，CDKN，PIK3A，DDR, KRAS and so on.
- The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss).
Show all 16Show fewer
- Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with RECIST 1.1 requirements.
- The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1.
- The expected lifetime is more than 12 weeks.
- The main organ function sits well, i.e. meets the following criteria (no blood transfusion, albumin, recombinant human platelet production or Colony-stimulating factor (CSF) treatment within 14 days prior to the first drug use in this study):
- (1). Absolute neutrophil count >15.0 x 10^9/L; (2). Platelet count ≥ 100 x 10^9/L; (3). Hemoglobins ≥ 90 g/L; (4). Total bilirubin ≤.5 x ULN (except Gilbert syndrome, total bilirubin ≤ 3.0 mg/dL); (5). AST (SGOT) ≤ 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (6). ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, ≤5.0 x ULN; (7). Clotting function: activated part of the clotting enzyme time (APTT) ≤ 1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) ≤1.5 x ULN; (8). Creatinine ≤1.5xULN, or creatinine clearance ≥60 mL/min (Cockcroft-Gault method).
- 11. Female patients must meet one of the following:
- . Menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause);
- . Sterilization performed (removal of the ovaries and/or uterus);
- . Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices.
- 12. Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception.
Who cannot join
- Received any of the following treatments: received systemic anti-tumor therapy (except neoadjuvant or adjuvant chemotherapy) previously; Within 4 weeks before the first administration of the drug, more than 30% of the bone marrow was treated with radiotherapy or a large area of radiation was carried out (except palliative radiotherapy for the purpose of relieving pain in non-target lesions only ); Other anti-tumor therapies, including molecular targeted therapies (EGFR TKI, angiogenesis inhibitors, etc.), immunotherapy (such as cellular immunotherapy anti-PD-1 or PD-L1), other experimental drug therapies, etc.
- Major surgery was performed within 4 weeks before the first administration of the study drug.
- Patients were taking (or cannot stop taking) certain medications or herbal supplements that are known to be a strong inducer of cytopigment P450 (CYP450) 3A4 within 1 week prior to the first administration of the study drug.
- Patients with dysphagia or possible absorption disorders as determined by the researcher.
- Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group.
- Patients with brain metastasis, the following could except:the largest diameter of brain metastasis lesions is less than 2 cm and no obvious symptoms; brain metastatic lesions have control, and stability more than 4 weeks.
Show all 12Show fewer
- Resting electrocardiogram (ECG) in rhythm, conduction and morphologically abnormal clinical significance, such as complete left bundle branch block, Ⅱ degrees above heart block, PR interval period > 250 milliseconds, etc.; myocardial infarction occurred within 6 months; presence of risk factors for prolonged QT interval or increased arrhythmia, such as heart failure, moderate or severe hypokalemia, diagnosed or suspected congenital long QT syndrome, a family history of long QT syndrome, or a history of sudden death under the age of 40 in a first-degree relative; mean QT interval (QTcF) after 3 Fridericia adjustments of electrocardiogram: > 450ms for males and > 470ms for females.
- Pregnant or lactating women.
- Hepatitis B virus infection (HBsAg positive, HBV-DNA >1000cps/ml and AST or ALT>2.0xULN), hepatitis C virus infection or HIV infection which is not controlled or in active.
- Other uncontrolled concomitant diseases include, but are not limited to infectious or active infections.
- A history of epilepsy, mental illness, or other social factors that limit adherence to the program.
- The researcher considers it inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients With Concurrent Driver Gene Mutations
This study is a randomized, multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small cell lung cancer, NSCLC) with concurrent Driver gene mutations，who used EGFR-TKI with or without combined chemotherapy，estimated with stable efficacy (CR, PR, and SD) .In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio:(A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
Read the detailed description
This study is a randomized, multicenter clinical study aimed at EGFR positive non-small-cell lung cancer (NSCLC) subjects with concurrent Driver gene mutations who have not previously received systematic treatment. After comparing EGFR-TKI alone or EGFR-TKI combined with chemotherapy for 4 cycles, after the efficacy evaluation was stable (CR, PR, and SD), the safety and clinical efficacy of maintenance therapy every 6 weeks were compared. The eligible subjects in this study will be randomly assigned into the following two groups according to the 1: 1 ratio: (A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy (pemetrexed plus carboplatin for 4 cycles ) During the course of the trial treatment, if the subject develops disease (the first PD), the researcher will decide whether to continue the medication according to the patient's situation and communicate with the patient, as follows: After the first PD of the subject, the researcher decides whether to continue the treatment with the original regimen according to the disease state of the subject. At least 4 weeks later, the tumor is evaluated again. If the tumor progresses again (the second PD), the subject's study treatment ends and the follow-up period is entered; if there is no progress, the original regimen is continued.
The primary end point was descriptive analysis of progression-free survival and Objective response rate.The secondary end point of this study was to compare the incidence of treatment-related grade 3-5 adverse events between the standard group and the controlled group. Using RECIST 1.1 as the evaluation standard, the independent imaging evaluation committee (IRRC) conducted the evaluation. For the first time to evaluate PD, regardless of whether they continue to study treatment after progression, the date of the first PD evaluated by IRRC will be used for all statistical analysis containing progress information.
- Conditions
- Non-small-lung-cell Cancer, NSCLC, EGFR Gene Mutation
- Being tested
- EGFR-TKI, EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)
- 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.
EGFR-TKIDrug
(A) Standard programme group, EGFR-TKI targeted therapy;
EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)Drug
(B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
| Study group | Role | What they receive |
|---|---|---|
| Standard programme group | Experimental | EGFR-TKI targeted therapy Receives: Drug: EGFR-TKI |
| controlled programme group | Active comparator | EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles ) Receives: Drug: EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
Measured: three years
objective response rate
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
Measured: three years
Secondary outcomes (1)
overall survival
The time from randomization to death due to any cause. For subjects who have been lost to follow-up before death, the time of the last follow-up is usually calculated as the time of death.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start23 Nov 2020
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-lung-cell CancerStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Wang, PhD, Study chair, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552613
- Sponsor's protocol ID
- K2020109
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2020
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Targeted Therapy Combined Chemotherapy in Advanced EGFR Positive NSCLC Patients With Concurrent Driver Gene Mutations
- ClinicalTrials.gov ID
- NCT04552613
- Acronym / sponsor ID
- K2020109
- Conditions
- Non-small-lung-cell Cancer, NSCLC, EGFR Gene Mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 17 Sep 2020 (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.
This study is a randomized, multicenter clinical study ，which is designed to compare the efficacy of the safety and efficacy of treatment every 6 weeks in EGFR positive (Non-small cell lung cancer, NSCLC) with concurrent Driver gene mutations，who used EGFR-TKI with or without combined chemotherapy，estimated with stable efficacy (CR, PR, and SD) .In this study, subjects will be randomly assigned to the following two groups according to a 1:1 ratio:(A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
Detailed description
This study is a randomized, multicenter clinical study aimed at EGFR positive non-small-cell lung cancer (NSCLC) subjects with concurrent Driver gene mutations who have not previously received systematic treatment. After comparing EGFR-TKI alone or EGFR-TKI combined with chemotherapy for 4 cycles, after the efficacy evaluation was stable (CR, PR, and SD), the safety and clinical efficacy of maintenance therapy every 6 weeks were compared. The eligible subjects in this study will be randomly assigned into the following two groups according to the 1: 1 ratio: (A) Standard programme group, EGFR-TKI targeted therapy; (B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy (pemetrexed plus carboplatin for 4 cycles ) During the course of the trial treatment, if the subject develops disease (the first PD), the researcher will decide whether to continue the medication according to the patient's situation and communicate with the patient, as follows: After the first PD of the subject, the researcher decides whether to continue the treatment with the original regimen according to the disease state of the subject. At least 4 weeks later, the tumor is evaluated again. If the tumor progresses again (the second PD), the subject's study treatment ends and the follow-up period is entered; if there is no progress, the original regimen is continued.
The primary end point was descriptive analysis of progression-free survival and Objective response rate.The secondary end point of this study was to compare the incidence of treatment-related grade 3-5 adverse events between the standard group and the controlled group. Using RECIST 1.1 as the evaluation standard, the independent imaging evaluation committee (IRRC) conducted the evaluation. For the first time to evaluate PD, regardless of whether they continue to study treatment after progression, the date of the first PD evaluated by IRRC will be used for all statistical analysis containing progress information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard programme group | Experimental | Drug: EGFR-TKIEGFR-TKI targeted therapy |
| controlled programme group | Active comparator | Drug: EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles ) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures.
- 18 to 80 years old (with critical values) when signing ICF.
- Histopathology or hemology diagnostics of phase IIIB or IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy.
- Patients have never received systemic treatment throughout the body for phase IIIB or IV NSCLC(Neoadjuvant or adjuvant chemotherapy is excluded).
- Known EGFR sensitivity mutations with concurrent other Driver gene mutations, such as T790M，TP53，RB1，PTEN，CDKN，PIK3A，DDR, KRAS and so on.
Key exclusion criteria (12 listed)
- Received any of the following treatments: received systemic anti-tumor therapy (except neoadjuvant or adjuvant chemotherapy) previously; Within 4 weeks before the first administration of the drug, more than 30% of the bone marrow was treated with radiotherapy or a large area of radiation was carried out (except palliative radiotherapy for the purpose of relieving pain in non-target lesions only ); Other anti-tumor therapies, including molecular targeted therapies (EGFR TKI, angiogenesis inhibitors, etc.), immunotherapy (such as cellular immunotherapy anti-PD-1 or PD-L1), other experimental drug therapies, etc.
- Major surgery was performed within 4 weeks before the first administration of the study drug.
- Patients were taking (or cannot stop taking) certain medications or herbal supplements that are known to be a strong inducer of cytopigment P450 (CYP450) 3A4 within 1 week prior to the first administration of the study drug.
- Patients with dysphagia or possible absorption disorders as determined by the researcher.
- Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, etc. can be included in the group.
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 |
|---|---|---|
| EGFR-TKI(A) Standard programme group, EGFR-TKI targeted therapy; | Drug | Standard programme group |
| EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)(B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles ) | Drug | controlled programme group |
Primary outcome
progression-free survival
Time frame: three years
Patients with oncological diseases have a period of time from the start of treatment to the observation of disease progression or death due to any cause
objective response rate
Time frame: three years
Refers to the proportion of patients whose tumor shrinkage reaches a certain amount and remains for a certain period of time, including CR + PR cases
1 secondary outcome
overall survival
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Non-small-lung-cell Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Kai Wang, PhD study chair
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGFR-TKI and EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin) in people with Non-small-lung-cell Cancer and NSCLC, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine 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 16 inclusion and 12 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: finished, as of the sponsor's last update on 16 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: three years). The study lists 2 primary outcomes in all. 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 16 Jan 2024.