Non-Small-Cell Lung CancerPhase 4TCL-1NCT02031601
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
A Phase 4 study testing Erlotinib, Gefitinib and Icotinib in people with Non-Small-Cell Lung Cancer, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- What is being tested?
- Erlotinib, Gefitinib and Icotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2017
- Phase
- Phase 4
- 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
- Adult patients, >=18 years of age;
- Advanced (stage IIIB/IV) non-small-cell lung cancer;
- Although stageⅠ-ⅢA, have contraindications to surgery;
- EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);
- Measurable disease;
- ECOG Performance Status 0 or 1 or 2.
Who cannot join
- Wild-type EGFR;
- Prior exposure to agents directed at the HER axis;
- Prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- Unstable systemic disease;
- Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
- Brain metastasis or spinal cord compression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC).
Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS).
Read more
Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.
Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.
- Conditions
- Non-Small-Cell Lung Cancer
- Being tested
- Erlotinib, Gefitinib, Icotinib, Docetaxel, Pemetrexed
- 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.
ErlotinibDrug
Also called Tarceva
150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression
GefitinibDrug
Also called Iressa
250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression
IcotinibDrug
Also called Conmana
125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression
DocetaxelDrug
75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
PemetrexedDrug
500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
Platinum (cisplatin or carboplatin)Drug
cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles
ErlotinibDrug
Also called Tarceva
150mg po once a day daily until disease progression
GefitinibDrug
Also called Iressa
250mg po once a day daily until disease progression
IcotinibDrug
Also called Conmana
125mg po three times a day daily until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin) Receives: Drug: Erlotinib; Drug: Gefitinib; Drug: Icotinib; Drug: Docetaxel; Drug: Pemetrexed; Drug: Platinum (cisplatin or carboplatin) |
| TKI alone therapy | Other | Interventions:
Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] Receives: Drug: Erlotinib; Drug: Gefitinib; Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: 8 weeks
Secondary outcomes (6)
Objective response rate
Measured: 8 weeks
Duration of response
Measured: 8 weeks
Time to progression
Measured: 8 weeks
Overall survival (OS)
Measured: 8 weeks
Clinical benefit rate
Measured: 8 weeks
Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qilu Hospital of Shandong University
- Investigators
- Yu Li, Professor, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031601
- Sponsor's protocol ID
- QLHX-0531
- Acronym
- TCL-1
- Status last verified
- Nov 2015
- First submitted
- 2 Jan 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
Publications
Xu L, Qi Q, Zhang Y, Cui J, Liu R, Li Y. Combination of icotinib and chemotherapy as first-line treatment for advanced lung adenocarcinoma in patients with sensitive EGFR mutations: A randomized controlled study. Lung Cancer. 2019 Jul;133:23-31. doi: 10.1016/j.lungcan.2019.05.008. Epub 2019 May 7.
PubMed 31200823
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled Study Comparing Chemotherapy Plus Intercalated EGFR-Tyrosine Kinase Inhibitors Combination Therapy With EGFR-Tyrosine Kinase Inhibitors Alone Therapy as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02031601
- Acronym / sponsor ID
- TCL-1 / QLHX-0531
- Conditions
- Non-Small-Cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jan 2014 (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.
Objective: To compare the efficacy and safety of chemotherapy plus intercalated EGFR-tyrosine kinase inhibitors (TKI) combination therapy with TKI alone therapy as first-line treatment for patients with non-small-cell lung cancer (NSCLC).
Methods: Patients with untreated, stage IIIB/IV, EGFR mutation-positive NSCLC will be randomly assigned to combination therapy group (receiving four cycles of docetaxel or pemetrexed (on day 1) plus platinum (on day 1) with intercalated TKI (gefitinib, erlotinib or Icotinib, on day 2-15) every 3 weeks) or TKI alone therapy (gefitinib, erlotinib or Icotinib, daily). All patients were continued to receive TKI until progression or unacceptable to toxicity or death. The primary endpoint was progression-free survivial (PFS).
Expected results: PFS of combination therapy group will be prolonged to nineteen months while PFS of TKI alone therapy group is ten months. Overall survival (OS) of combination therapy group will be prolonged to 36 months while OS of TKI alone therapy group is 26 months.
Hypothesis: Platinum-based chemotherapy plus intercalated TKI combination therapy as first-line treatment will prolong PFS and OS for patients with NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: Erlotinib, Drug: Gefitinib, Drug: Icotinib, Drug: Docetaxel, Drug: Pemetrexed, Drug: Platinum (cisplatin or carboplatin)Interventions: Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] plus Drug: Docetaxel for patients of lung squamous cell carcinoma; Pemetrexed for patients of lung adenocarcinoma plus Drug: Platinum (cisplatin or carboplatin) |
| TKI alone therapy | Other | Drug: Erlotinib, Drug: Gefitinib, Drug: IcotinibInterventions: Drug: Erlotinib [Tarceva] or Gefitinib [Iressa] or Icotinib [Conmana] |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients, >=18 years of age;
- Advanced (stage IIIB/IV) non-small-cell lung cancer;
- Although stageⅠ-ⅢA, have contraindications to surgery;
- EGFR mutation-positive (EGFR exon-18, exon-19 or exon-21);
- Measurable disease;
Key exclusion criteria (6 listed)
- Wild-type EGFR;
- Prior exposure to agents directed at the HER axis;
- Prior chemotherapy or systemic anti-tumor therapy after advanced disease;
- Unstable systemic disease;
- Any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
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 |
|---|---|---|
| ErlotinibAlso: Tarceva150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression | Drug | Combination therapy |
| GefitinibAlso: Iressa250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression | Drug | Combination therapy |
| IcotinibAlso: Conmana125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression | Drug | Combination therapy |
| Docetaxel75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles | Drug | Combination therapy |
| Pemetrexed500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles | Drug | Combination therapy |
| Platinum (cisplatin or carboplatin)cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles | Drug | Combination therapy |
| ErlotinibAlso: Tarceva150mg po once a day daily until disease progression | Drug | TKI alone therapy |
| GefitinibAlso: Iressa250mg po once a day daily until disease progression | Drug | TKI alone therapy |
| IcotinibAlso: Conmana125mg po three times a day daily until disease progression | Drug | TKI alone therapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 8 weeks
Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
6 secondary outcomes
Objective response rate
Time frame: 8 weeks
Duration of response
Time frame: 8 weeks
Time to progression
Time frame: 8 weeks
Overall survival (OS)
Time frame: 8 weeks
Clinical benefit rate
Time frame: 8 weeks
Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory data
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
- Derived from this study: PubMed 31200823Xu L, Qi Q, Zhang Y, Cui J, Liu R, Li Y. Combination of icotinib and chemotherapy as first-line treatment for advanced lung adenocarcinoma in patients with sensitive EGFR mutations: A randomized controlled study. Lung Cancer. 2019 Jul;133:23-31. doi: 10.1016/j.lungcan.2019.05.008. Epub 2019 May 7.
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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.
Yu Li, Professor study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erlotinib, Gefitinib and Icotinib in people with Non-Small-Cell Lung Cancer, run by Qilu Hospital of Shandong 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 6 inclusion and 6 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 29 Mar 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Qian Qi, MS (008615165197262, 610160008@qq.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: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031601, which also lists 1 linked publication.
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 29 Mar 2016.