Lung, CarcinomaPhase 2NCT03151161
Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
A Phase 2 study testing Icotinib,Pemetrexed,Carboplatin and Icotinib in people with Lung, Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung, Carcinoma
- What is being tested?
- Icotinib,Pemetrexed,Carboplatin and Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to May 2019
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with histologically proven diagnosis of non-Squamous NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy, such as surgery or radiotherapy and so on.
- Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation.
- Measurable lesions according to RECIST 1.1 criteria.
- Patients between 18 and 75 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
- Estimated life expectancy of ≥12 weeks.
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- Haematological stable: ANC > 1.5; PLT > 100; HGB > 90 g/L.
- Adequate liver function: total bilirubin < 1.5 x ULN; AST and ALT < 2.5 x ULN (without liver metastasis); or AST and ALT < 5 x ULN (with liver metastasis).
- Adequate renal function: creatinine < 1.5 x ULN; CCR >= 50ml/min; and urine protein < 2+; for the patients with urine protein >= 2+, 24 hours total urine protein <= 1g.
- INR <= 1.5; aPTT < 1.5 x ULN, within 7 days before treatment.
- For female patients, pregnancy test (blood or urine) needs to be done within 7 days before treatment; if negative, patients need to be consented for proper contraception throughout the treatment and 8 weeks after the completion of treatment. For male patients, they also need to be consented for proper contraception throughout the treatment and 8 weeks after the completion of treatment.
- Signed informed consent document on file.
- Patient compliance and geographic proximity that allow adequate follow up.
Who cannot join
- Histology is confirmed to be squamous cell carcinoma, mixed NSCLC and SCLC, or squamous cell carcinoma dominant adenosquamous carcinoma.
- Patients previously had targeting HER therapy, including erlotinib, gefitinib, cetuximab，trastuzumab, etc.
- Patients previously had systemic therapy for NSCLC before study, including cytotoxic medicine, target therapy, or other medicines in a clinical trial.
- Physiological incompetence with upper gastrointestinal tract, or malabsorption syndrome, or intolerance of oral drugs, or active peptic ulceration.
- Clinically moderate to severe COPD, active ILD or other pulmonary diseases defined by researchers.
- Uncontrolled ocular inflammation or infection, or other conditions that could lead to ocular inflammation or infection.
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- Conditions or risk factors that contraindicate the research medicines.
- Any unsteady systematic diseases, including active infection, uncontrolled high blood pressure, unstable angina, recent angina (within 3 months), congestive heart failure, ischemic heart diseases (within 6 months), severe arrhythmia， severe liver/renal/metabolic diseases.
- Known HIV infection.
- Unhealed wound, active peptic ulceration or fracture.
- Pregnancy or lactation.
- Female patients who refuse contraception throughout treatment and 6 months after the treatment; male patients who refuse contraception throughout treatment and 90 days after the treatment.
- Known severe hypersensitivity to Icotinib, Pemetrexed or Carboplatin.
- Patients with esophago-tracheal fistula.
- Pleural effusion or pericardiac effusion that cannot be controlled by drainage or other procedures.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- Patients had other malignancies apart from NSCLC, except cervical cancer in situ, skin basal cell carcinoma or squamous cell carcinoma, prostate cancer or breast ductal carcinoma in situ that have been adequately treated.
Trial locations and contacts
1 site in 1 country.
China1 site
Study site
Guanzhou, Guangdong, 510000
Long Hao, Prof, +86 2087343261, longhao@sysucc.org.cn
Ruping Xing, +86 2087343736, xingrp@sysucc.org.cn
About this study
Official title: A Prospective,Multi-center, Open-labeled Phase 2 Randomized and Comparative Clinical Study of First Line Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. The OPTIMAl trial indicated that those who received TKI and chemotherapy during the whole treatment window survived longest. Unfortunately, previous studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed to improve survival in unselected patients. To avoid the potential synergistic antagonism, the FAST-ACT II trial committed a sequential strategy and find a superiority in the combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.
On the basis of these and other studies, the investigators hypothesized that a better sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out window before chemotherapy) would be more efficacious than chemotherapy alone. In this study, the investigators investigate the efficacy(PFS:progression free survival), safety, and adverse-event profile of chemotherapy plus intermittent and maintenance of icotinib compared with icotinib single drug, when these drugs were used as first-line treatment in who had non-squamous lung carcinoma with EGFR gene mutation in China.
- Conditions
- Lung, Carcinoma
- Being tested
- Icotinib,Pemetrexed,Carboplatin, Icotinib
- Keywords
- chemotherapy, maintenance therapy, icotinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icotinib,Pemetrexed,CarboplatinDrug
Pemetrexed (500mg/m2) + Carboplatin (AUC=5), every 3 weeks, maximum 4 cycles; icotinib 125mg, three times a day, d2-15 in each cycle, and icotinib 125mg,three times a day, since the last cycle until disease progression
IcotinibDrug
Single drug: Icotinib 125mg, three times a day, continuous until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 1. Chemotherapy regime: Pemetrexed (500mg/m2) + Carboplatin (AUC=5), 1 cycle every 3 weeks, maximum 4 cycles;
2. Intermittent regime: Icotinib 125mg, three times a day, d2-15 in each cycle; maintenance regime: icotinib 125mg, three times a day, since the last cycle until disease progression. Receives: Drug: Icotinib,Pemetrexed,Carboplatin |
| Control Group | Active comparator | Single drug: Icotinib 125mg, three times a day, continous until disease progression Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
Patients were images with computed tomography (CT) scan
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startDec 2015
- Primary completion31 Dec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung, CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151161
- Sponsor's protocol ID
- 201512001
- Status last verified
- Jun 2018
- First submitted
- 11 May 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Multi-center, Open-labeled Phase 2 Randomized and Comparative Clinical Study of First Line Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
- ClinicalTrials.gov ID
- NCT03151161
- Acronym / sponsor ID
- 201512001
- Conditions
- Lung, Carcinoma
- Keywords
- chemotherapy, maintenance therapy, icotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 12 May 2017 (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.
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. The OPTIMAl trial indicated that those who received TKI and chemotherapy during the whole treatment window survived longest. Unfortunately, previous studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed to improve survival in unselected patients. To avoid the potential synergistic antagonism, the FAST-ACT II trial committed a sequential strategy and find a superiority in the combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.
On the basis of these and other studies, the investigators hypothesized that a better sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out window before chemotherapy) would be more efficacious than chemotherapy alone. In this study, the investigators investigate the efficacy(PFS:progression free survival), safety, and adverse-event profile of chemotherapy plus intermittent and maintenance of icotinib compared with icotinib single drug, when these drugs were used as first-line treatment in who had non-squamous lung carcinoma with EGFR gene mutation in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Icotinib,Pemetrexed,Carboplatin1. Chemotherapy regime: Pemetrexed (500mg/m2) + Carboplatin (AUC=5), 1 cycle every 3 weeks, maximum 4 cycles; 2. Intermittent regime: Icotinib 125mg, three times a day, d2-15 in each cycle; maintenance regime: icotinib 125mg, three times a day, since the last cycle until disease progression. |
| Control Group | Active comparator | Drug: IcotinibSingle drug: Icotinib 125mg, three times a day, continous until disease progression |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Present with histologically proven diagnosis of non-Squamous NSCLC Stage IIIB or IV as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy, such as surgery or radiotherapy and so on.
- Confirmed activating mutation of EGFR-ie, an exon 19 deletion or an exon 21 L858R point mutation.
- Measurable lesions according to RECIST 1.1 criteria.
- Patients between 18 and 75 years of age.
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
Key exclusion criteria (18 listed)
- Histology is confirmed to be squamous cell carcinoma, mixed NSCLC and SCLC, or squamous cell carcinoma dominant adenosquamous carcinoma.
- Patients previously had targeting HER therapy, including erlotinib, gefitinib, cetuximab，trastuzumab, etc.
- Patients previously had systemic therapy for NSCLC before study, including cytotoxic medicine, target therapy, or other medicines in a clinical trial.
- Physiological incompetence with upper gastrointestinal tract, or malabsorption syndrome, or intolerance of oral drugs, or active peptic ulceration.
- Clinically moderate to severe COPD, active ILD or other pulmonary diseases defined by researchers.
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 |
|---|---|---|
| Icotinib,Pemetrexed,CarboplatinPemetrexed (500mg/m2) + Carboplatin (AUC=5), every 3 weeks, maximum 4 cycles; icotinib 125mg, three times a day, d2-15 in each cycle, and icotinib 125mg,three times a day, since the last cycle until disease progression | Drug | Experimental Group |
| IcotinibSingle drug: Icotinib 125mg, three times a day, continuous until disease progression. | Drug | Control Group |
Primary outcome
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1
Time frame: eight weeks
Patients were images with computed tomography (CT) scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Icotinib,Pemetrexed,Carboplatin and Icotinib in people with Lung, Carcinoma, run by Sun Yat-sen University 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 13 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 7 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Long, Prof (+86 20 87343261, longhao@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 (time frame: eight 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 7 Jun 2018.