EGF-R Positive Non-Small Cell Lung CancerPhase 2NCT03349203
Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer
A Phase 2 study testing Icotinib in people with EGF-R Positive Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- EGF-R Positive Non-Small Cell Lung Cancer
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Dec 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA
- No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or biological therapy
- Stage IIIB or IV Oligometastasis Non-small Cell Lung Cancer. (a) stage IV Oligometastasis: the metastasis organ mainly include: 1. adrenal metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy; 2. brain metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy. At the same time, the primary lesion of the lung can be completely removed, which should be T1-2, N0-1 or T3, N0. (b) stage IIIB (T1-3, N3): it is limited to patients who are unsuitable or refuse to accept pulmonary primary lesion radiotherapy. It only include subclavian lymph node or anterior scalenus lymph node metastasis (mediastinal lymph node metastasis is excluded by PET-CT). The metastasis lesion should be single or less than 3, its diameter is no more than 3 cm and can be potentially resected.
- Sufficient tumor histological specimens (non-cytology) for molecular marker analysis
- At least one lesion with measurable diameter and its longest diameter is large than 10 mm by CT measurement
Who cannot join
- Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or monoclonal antibodies) and experimental treatment, etc
- Previous local radiotherapy of Non-small Cell Lung Cancer
- Be allergic to any component of Icotinib tablet (Conmana)
- Other cancers within five years prior to the treatment of this study. Except for cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta and Tis)
- Any instable systemic disease, including: active infection, high blood pressure out of control, unstable angina, onset of angina pectoris within the past 3 months, congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic disease
- Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy or any active intersexual lung disease with clinical evidence
Show all 14Show fewer
- Idiopathic pulmonary fibrosis detected by CT scan at baseline;
- Not fully controlled eye inflammation or infections, or any condition that may lead to the above eye diseases
- Human immunodeficiency virus infection
- Patients undergoing major surgery or severe trauma within 2 months prior to the first use of the experimental drug
- Patients with Small Cell Lung Cancer
- Pregnant or lactating women
- Neurological or psychiatric disorders history, including epilepsy or dementia
- Other situations not appropriate to enter the group considering by the investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Science
Beijing
Shugeng Gao, MD
Feiyue Feng, MD
About this study
Official title: Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study
The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.
Read the detailed description
Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then they receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy.
- Being tested
- Icotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called Conmana
Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day by mouth for 8 weeks as neoadjuvant therapy before surgery and 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks before surgery and 2 years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate as assessed by RECIST1.1
Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1.
Measured: eight weeks
Secondary outcomes (4)
Disease Control Rate as assessed by RECIST1.1
Disease Control Rate was defined as the total percentage of participants except for those with tumor lesions diameters increased by at least 20% as assessed by RECIST1.1.
Measured: five years after surgery
Time to Tumor Progression as assessed by RECIST1.1
Time to Tumor Progression was defined as the time between participants' randomization and their tumor progression as assessed by RECIST1.1.
Measured: five years after surgery
Overall survival of participants
Overall survival was defined as the time from participants' randomization to their death due to any cause.
Measured: five years after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 would be recorded and calculated after them participating into the study and taking the experimental drug.
Measured: five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Oct 2018 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGF-R Positive Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shugeng Gao, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349203
- Sponsor's protocol ID
- BD-IC-IV81
- Status last verified
- Jan 2018
- First submitted
- 16 Nov 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icotinib as Neoadjuvant and Adjuvant Therapy in EGFR-mutant Stage IIIB or Oligometastasis Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT03349203
- Acronym / sponsor ID
- BD-IC-IV81
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Nov 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.
The main purpose of this study is to evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy in EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery.
Detailed description
Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then they receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the pulmonary and metastases lesions objective response rate after Icotinib preoperative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: IcotinibPatients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks before surgery and 2 years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA
- No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or biological therapy
- Stage IIIB or IV Oligometastasis Non-small Cell Lung Cancer. (a) stage IV Oligometastasis: the metastasis organ mainly include: 1. adrenal metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy; 2. brain metastasis which can be potentially resected by surgery or radically treated by SRS radiotherapy. At the same time, the primary lesion of the lung can be completely removed, which should be T1-2, N0-1 or T3, N0. (b) stage IIIB (T1-3, N3): it is limited to patients who are unsuitable or refuse to accept pulmonary primary lesion radiotherapy. It only include subclavian lymph node or anterior scalenus lymph node metastasis (mediastinal lymph node metastasis is excluded by PET-CT). The metastasis lesion should be single or less than 3, its diameter is no more than 3 cm and can be potentially resected.
- Sufficient tumor histological specimens (non-cytology) for molecular marker analysis
- At least one lesion with measurable diameter and its longest diameter is large than 10 mm by CT measurement
Key exclusion criteria (14 listed)
- Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or monoclonal antibodies) and experimental treatment, etc
- Previous local radiotherapy of Non-small Cell Lung Cancer
- Be allergic to any component of Icotinib tablet (Conmana)
- Other cancers within five years prior to the treatment of this study. Except for cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta and Tis)
- Any instable systemic disease, including: active infection, high blood pressure out of control, unstable angina, onset of angina pectoris within the past 3 months, congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic disease
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 |
|---|---|---|
| IcotinibAlso: ConmanaPatients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day by mouth for 8 weeks as neoadjuvant therapy before surgery and 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity. | Drug | Icotinib |
Primary outcome
Objective Response Rate as assessed by RECIST1.1
Time frame: eight weeks
Objective Response Rate was defined as the percentage of participants whose tumor lesions disappear completely or diameters reduced by at least 30% as assessed by RECIST1.1.
4 secondary outcomes
Disease Control Rate as assessed by RECIST1.1
Time frame: five years after surgery
Time to Tumor Progression as assessed by RECIST1.1
Time frame: five years after surgery
Overall survival of participants
Time frame: five years after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: five years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: Yes
Related trials for EGF-R Positive Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer
Active, not recruitingPhase 2
Dacomitinib in Lung Cancer With Uncommon EGFR Mutations
Non-small Cell Lung Cancer Metastatic, EGF-R Positive Non-Small Cell Lung Cancer
Not yet recruitingEarly Phase 1
CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC
Non Small Cell Lung Cancer, Circulating Tumor Cell
RecruitingPhase 1/2
The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC
Non Small Cell Lung Cancer, RET Gene Mutation
Not yet recruiting
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
EGF-R Positive 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.
Shugeng Gao principal investigator
Cancer Hospital Chinese Academy of Medical Science
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 in people with EGF-R Positive Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. 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 5 inclusion and 14 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 18 Jul 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 Shugeng Gao, MD (13801185056, gaoshugeng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate as assessed by RECIST1.1 (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 18 Jul 2018.