Lung AdenocarcinomaPhase 2NCT02951637
Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
A Phase 2 study testing Pemetrexed plus carboplatin combined with gefitinib and Gefitinib in people with Lung Adenocarcinoma, run by Shanghai Chest Hospital.
Trial summary
The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Adenocarcinoma
- What is being tested?
- Pemetrexed plus carboplatin combined with gefitinib and Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients had to voluntarily join the study and give written informed consent for the study;
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
- A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
- Sensitive EGFR mutations (19del, 21L858R);
- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
- Patients did not receive systemic anti-cancer therapy previously;
- Able to comply with study and follow-up procedures;
- Age >= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;
Who cannot join
- Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
- Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
- EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
- Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];
- Symptomatic or untreated brain metastases;
- Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible);
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- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications;
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;
- Pregnancy or lactation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.
Read the detailed description
The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.
In addition, the overall survival and safety index will be collected for analyses.
- Conditions
- Lung Adenocarcinoma
- Being tested
- Pemetrexed plus carboplatin combined with gefitinib, Gefitinib
- Keywords
- Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin
- Medical subject headings
- Adenocarcinoma of Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pemetrexed plus carboplatin combined with gefitinibDrug
Also called Combination of chemotherapy and EGFR TKI
Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.
GefitinibDrug
Also called EGFR TKI
Gefitinib (250mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib Receives: Drug: Pemetrexed plus carboplatin combined with gefitinib |
| Group B | Experimental | Patient will be administrated with gefitinib Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: 16 months
Secondary outcomes (3)
overall survival (OS)
Measured: 32 months
Objective response rate (ORR)
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Changhai Hospital
- Responsible party
- Principal investigator, Aiqin Gu, Shanghai Chest Hospital
- Investigators
- Aiqin Gu, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02951637
- Sponsor's protocol ID
- Chest004
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02951637
- Acronym / sponsor ID
- Chest004
- Conditions
- Lung Adenocarcinoma
- Keywords
- Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Changhai Hospital
- Study start
- Dec 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Nov 2016 (estimated)
- 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 this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.
Detailed description
The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.
In addition, the overall survival and safety index will be collected for analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Pemetrexed plus carboplatin combined with gefitinibPatient will be administrated with Pemetrexed plus carboplatin combined with gefitinib |
| Group B | Experimental | Drug: GefitinibPatient will be administrated with gefitinib |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients had to voluntarily join the study and give written informed consent for the study;
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
- A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
- Sensitive EGFR mutations (19del, 21L858R);
- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
Key exclusion criteria (9 listed)
- Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
- Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
- EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
- Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];
- Symptomatic or untreated brain metastases;
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 carboplatin combined with gefitinibAlso: Combination of chemotherapy and EGFR TKIPemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks. | Drug | Group A |
| GefitinibAlso: EGFR TKIGefitinib (250mg daily) | Drug | Group B |
Primary outcome
Progression-free survival (PFS)
Time frame: 16 months
3 secondary outcomes
overall survival (OS)
Time frame: 32 months
Objective response rate (ORR)
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- 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.
Aiqin Gu, MD principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed plus carboplatin combined with gefitinib and Gefitinib in people with Lung Adenocarcinoma, run by Shanghai Chest Hospital.
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 9 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 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Aiqin Gu, MD (13916720655, Guaiqin11@126.com), 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: 16 months). 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 1 Nov 2016.