Advanced Lung AdenocarcinomaPhase 3NCT05204758
Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect
A Phase 3 study testing TCM Formula in people with Advanced Lung Adenocarcinoma, run by China Medical University Hospital.
Trial summary
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become standard practice for advanced non-small cell lung cancer (NSCLC) with EGFR gene mutation. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were Food and Drug Administration (FDA) approved since 2006 and given payment… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Lung Adenocarcinoma
- What is being tested?
- TCM Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2016to 28 Feb 2021
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed diagnosis of locally advanced or metastatic lung adenocarcinoma with EGFR mutations,
- Patients with an Eastern Cooperative Oncology Group performance status score of 0-2,
- Patients receiving afatinib as first-line treatment to ensure a shorter time to observe skin adverse effects of any grade,
- Patients with measurable disease evaluated by the Response Evaluation Criteria in Solid Tumors (version 1.1),
- Patients with brain metastases were included after adequate treatment.
Who cannot join
None listed.
About this study
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become standard practice for advanced non-small cell lung cancer (NSCLC) with EGFR gene mutation. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were Food and Drug Administration (FDA) approved since 2006 and given payment continuously for lung adenocarcinoma with EGFR mutation in Taiwan.
Several researches mention the positive correlation between skin toxicities and clinical response, such as improved median survival, overall survival and progression-free survival. Nevertheless, quite a few patients reduced dose or discontinued EGFR-TKIs because of prolonged or intolerable adverse effects, thus causing disease progress and even death. Based on the experts' opinion, some basic strategies have been developed to manage dermatologic adverse effects. Those strategies have the potential to improve patient quality of life and to prevent dose reductions or discontinuation.
Read more
The concept of prophylaxis in EGFR-TKI related adverse effects had existed for rash and diarrhea, but it is not well spread. Although several studies indicate that Traditional Chinese Medicine (TCM) facilitates the treatment of lung cancer, clinical analysis of prophylactic TCM in EGFR-TKIs related skin toxicities remains absent. Based on TCM syndrome differentiation and treatment and clinical experiences, the investigators have found effective TCM compositions to relieve these toxicities.
Therefore, the investigators develop a pilot, prospective, double-blinded, randomized controlled TCM research to prevent EGFR- TKIs related dermatological adverse effects. The purpose of this study suggest that TCM could provide synergic effect with EGFR-TKIs, which means TCM could reduce and prevent EGFR-TKIs related dermatological adverse effects without interfering formulary cancer therapy. The investigators hypothesize that prophylactic TCM with standard of care will delay any grade skin toxicity to 14 days as well as reduce the incidence of grade 3 skin toxicity from 30% to less than 10%.
Due to high EGFR mutation rate of lung adenocarcinoma in Taiwan, it is necessary to investigate whether combination of TCM is beneficial to patients of advanced lung adenocarcinoma with EGFR gene mutation.
Read the detailed description
Lung cancer is the leading cause of cancer deaths worldwide. According to National Comprehensive Cancer Network (NCCN) Guidelines, EGFR-TKIs have become standard practice for advanced NSCLC with EGFR gene mutation. An epidemiological study in 2012 reported that EGFR mutations from Asian advanced lung adenocarcinoma patients were 22-64% and the rate in Taiwan was 62.1%. Another epidemiological study in 2015 showed that the EGFR mutation rate of treatment -naïve lung adenocarcinoma in Taiwan was 55.4%.
Depend on several extensive studies, oral treatment of EGFR-TKIs improved progression free survival (PFS) about 9.2-13.6% than traditional chemotherapy. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were FDA approved since 2006 and given payment continuously for lung adenocarcinoma with EGFR mutation in Taiwan.
Several researches mention the positive correlation between skin toxicities and clinical response, such as improved median survival, overall survival and progression-free survival. Nevertheless, quite a few patients reduced dose or discontinued EGFR-TKIs because of prolonged or intolerable adverse effects, thus causing disease progress and even death. Based on the experts' opinion, some basic strategies have been developed to manage dermatologic adverse effects. Those strategies have the potential to improve patient quality of life and to prevent dose reductions or discontinuation.
The concept of prophylaxis in EGFR-TKI related adverse effects had existed for rash and diarrhea, but it is not well spread. Although several studies indicate that TCM facilitates the treatment of lung cancer, clinical analysis of prophylactic TCM in EGFR-TKIs related skin toxicities remains absent. Based on TCM syndrome differentiation and treatment and clinical experiences, the investigators have found effective TCM compositions to relieve these toxicities.
Therefore, the investigators develop a pilot, prospective, double-blinded, randomized controlled TCM research to prevent EGFR- TKIs related dermatological adverse effects. The purpose of this study suggest that TCM could provide synergic effect with EGFR-TKIs, which means TCM could reduce and prevent EGFR-TKIs related dermatological adverse effects without interfering formulary cancer therapy. The investigators hypothesize that prophylactic TCM with standard of care will delay any grade skin toxicity to 14 days as well as reduce the incidence of grade 3 skin toxicity from 30% to less than 10%.
Due to high EGFR mutation rate of lung adenocarcinoma in Taiwan, it is necessary to investigate whether combination of TCM is beneficial to patients of advanced lung adenocarcinoma with EGFR gene mutation.
- Conditions
- Advanced Lung Adenocarcinoma
- Being tested
- TCM Formula, Placebo
- Keywords
- advanced lung adenocarcinoma, EGFR-TKI, traditional Chinese medicine, skin toxicity, quality of life, prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM FormulaDrug
three packages of TCM preparations with each meal three times a day
PlaceboDrug
three packages of placebo preparations with each meal three times a day
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Patients receive afatinib and TCM. TCM recipe was chosen from three essential TCM formulas, including Bai He Gu Jin Tang (yin nourishing), Wen Dan Tang (phlegm reducing), and Qing Shang Fang Fen Tang (heat clearing). The packages contained 1.6 g TCM preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of TCM preparations with each meal three times a day, for a total of nine packages per day. Administration of TCM was initiated at the same time as afatinib and continued for a total of three months. Receives: Drug: TCM Formula |
| Control arm | Placebo comparator | Patients receive afatinib and placebo. Placebo without the medical ingredients was prepared to be similar to the weight, color, smell, taste, and packaging of the TCM formulas. The packages contained 1.6 g placebo preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of placebo preparations with each meal three times a day, for a total of nine packages per day. Administration of placebo was initiated at the same time as afatinib and continued for a total of three months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to skin toxicity of any grade
Patients were instructed to maintain a diary to record the date on which skin toxicity of any grade first presented.
Measured: 3 month
incidence of grade 3 skin toxicity
Patients were instructed to maintain a diary to record the date on which maximum EGFR-TKI-related skin toxicities occurred.
Measured: 3 months
Secondary outcomes (4)
safety evaluation
Safety evaluation included complete blood and differential counts, renal and liver function tests, and tumor markers.
Measured: 3 months
quality of life evaluation
Quality of life evaluation included Dermatology Life Quality Index, Functional Assessment of Cancer Therapy-Lung (FACT-L; version 4), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-C30/LC13 version 3.0), and Eastern Cooperative Oncology Group performance status (ECOG PS) scale.
Measured: 3 months
progression free survival
Tumor response to EGFR-TKIs was assessed by chest X-ray once a month and chest computed tomography once every three months.
Measured: 3 years
overall survival
Tumor response to EGFR-TKIs was assessed by chest X-ray once a month and chest computed tomography once every three months.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start12 May 2016
- Primary completion31 Dec 2017
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Advanced Lung AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by China Medical University 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsiang Li, Attending, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05204758
- Sponsor's protocol ID
- CMUH105-REC1-055
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melosky B, Leighl NB, Rothenstein J, Sangha R, Stewart D, Papp K. Management of egfr tki-induced dermatologic adverse events. Curr Oncol. 2015 Apr;22(2):123-32. doi: 10.3747/co.22.2430.
PubMed 25908911Takeda M, Okamoto I, Nakagawa K. Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. Lung Cancer. 2015 Apr;88(1):74-9. doi: 10.1016/j.lungcan.2015.01.026. Epub 2015 Feb 7.
PubMed 25704957Melosky B, Anderson H, Burkes RL, Chu Q, Hao D, Ho V, Ho C, Lam W, Lee CW, Leighl NB, Murray N, Sun S, Winston R, Laskin JJ. Pan Canadian Rash Trial: A Randomized Phase III Trial Evaluating the Impact of a Prophylactic Skin Treatment Regimen on Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor-Induced Skin Toxicities in Patients With Metastatic Lung Cancer. J Clin Oncol. 2016 Mar 10;34(8):810-5. doi: 10.1200/JCO.2015.62.3918. Epub 2015 Nov 16.
PubMed 26573073Yang XB, Wu WY, Long SQ, Deng H, Pan ZQ. Effect of gefitinib plus Chinese herbal medicine (CHM) in patients with advanced non-small-cell lung cancer: a retrospective case-control study. Complement Ther Med. 2014 Dec;22(6):1010-8. doi: 10.1016/j.ctim.2014.10.001. Epub 2014 Oct 12.
PubMed 25453521Liu ZL, Zhu WR, Zhou WC, Ying HF, Zheng L, Guo YB, Chen JX, Shen XH. Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: a systematic review and meta-analysis. J Integr Med. 2014 Jul;12(4):346-58. doi: 10.1016/S2095-4964(14)60034-0.
PubMed 25074884Li CL, Hsia TC, Yang ST, Chao KC, Tu CY, Chen HJ, Li CH. Efficacy of Prophylactic Traditional Chinese Medicine on Skin Toxicity of Afatinib in EGFR Mutation-Positive Advanced Lung Adenocarcinoma: A Single-Center, Prospective, Double-Blinded, Randomized-Controlled Pilot Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221086663. doi: 10.1177/15347354221086663.
PubMed 35297709
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic TCM for Mitigation of EGFR-TKI Related Dermatological Adverse Effect
- ClinicalTrials.gov ID
- NCT05204758
- Acronym / sponsor ID
- CMUH105-REC1-055
- Conditions
- Advanced Lung Adenocarcinoma
- Keywords
- advanced lung adenocarcinoma, EGFR-TKI, traditional Chinese medicine, skin toxicity, quality of life, prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 12 May 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 24 Jan 2022 (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.
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become standard practice for advanced non-small cell lung cancer (NSCLC) with EGFR gene mutation. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were Food and Drug Administration (FDA) approved since 2006 and given payment continuously for lung adenocarcinoma with EGFR mutation in Taiwan.
Several researches mention the positive correlation between skin toxicities and clinical response, such as improved median survival, overall survival and progression-free survival. Nevertheless, quite a few patients reduced dose or discontinued EGFR-TKIs because of prolonged or intolerable adverse effects, thus causing disease progress and even death. Based on the experts' opinion, some basic strategies have been developed to manage dermatologic adverse effects. Those strategies have the potential to improve patient quality of life and to prevent dose reductions or discontinuation.
The concept of prophylaxis in EGFR-TKI related adverse effects had existed for rash and diarrhea, but it is not well spread. Although several studies indicate that Traditional Chinese Medicine (TCM) facilitates the treatment of lung cancer, clinical analysis of prophylactic TCM in EGFR-TKIs related skin toxicities remains absent. Based on TCM syndrome differentiation and treatment and clinical experiences, the investigators have found effective TCM compositions to relieve these toxicities.
Therefore, the investigators develop a pilot, prospective, double-blinded, randomized controlled TCM research to prevent EGFR- TKIs related dermatological adverse effects. The purpose of this study suggest that TCM could provide synergic effect with EGFR-TKIs, which means TCM could reduce and prevent EGFR-TKIs related dermatological adverse effects without interfering formulary cancer therapy. The investigators hypothesize that prophylactic TCM with standard of care will delay any grade skin toxicity to 14 days as well as reduce the incidence of grade 3 skin toxicity from 30% to less than 10%.
Due to high EGFR mutation rate of lung adenocarcinoma in Taiwan, it is necessary to investigate whether combination of TCM is beneficial to patients of advanced lung adenocarcinoma with EGFR gene mutation.
Detailed description
Lung cancer is the leading cause of cancer deaths worldwide. According to National Comprehensive Cancer Network (NCCN) Guidelines, EGFR-TKIs have become standard practice for advanced NSCLC with EGFR gene mutation. An epidemiological study in 2012 reported that EGFR mutations from Asian advanced lung adenocarcinoma patients were 22-64% and the rate in Taiwan was 62.1%. Another epidemiological study in 2015 showed that the EGFR mutation rate of treatment -naïve lung adenocarcinoma in Taiwan was 55.4%.
Depend on several extensive studies, oral treatment of EGFR-TKIs improved progression free survival (PFS) about 9.2-13.6% than traditional chemotherapy. EGFR-TKIs involving Afatinib, Erlotinib, and Gefitinib were FDA approved since 2006 and given payment continuously for lung adenocarcinoma with EGFR mutation in Taiwan.
Several researches mention the positive correlation between skin toxicities and clinical response, such as improved median survival, overall survival and progression-free survival. Nevertheless, quite a few patients reduced dose or discontinued EGFR-TKIs because of prolonged or intolerable adverse effects, thus causing disease progress and even death. Based on the experts' opinion, some basic strategies have been developed to manage dermatologic adverse effects. Those strategies have the potential to improve patient quality of life and to prevent dose reductions or discontinuation.
The concept of prophylaxis in EGFR-TKI related adverse effects had existed for rash and diarrhea, but it is not well spread. Although several studies indicate that TCM facilitates the treatment of lung cancer, clinical analysis of prophylactic TCM in EGFR-TKIs related skin toxicities remains absent. Based on TCM syndrome differentiation and treatment and clinical experiences, the investigators have found effective TCM compositions to relieve these toxicities.
Therefore, the investigators develop a pilot, prospective, double-blinded, randomized controlled TCM research to prevent EGFR- TKIs related dermatological adverse effects. The purpose of this study suggest that TCM could provide synergic effect with EGFR-TKIs, which means TCM could reduce and prevent EGFR-TKIs related dermatological adverse effects without interfering formulary cancer therapy. The investigators hypothesize that prophylactic TCM with standard of care will delay any grade skin toxicity to 14 days as well as reduce the incidence of grade 3 skin toxicity from 30% to less than 10%.
Due to high EGFR mutation rate of lung adenocarcinoma in Taiwan, it is necessary to investigate whether combination of TCM is beneficial to patients of advanced lung adenocarcinoma with EGFR gene mutation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: TCM FormulaPatients receive afatinib and TCM. TCM recipe was chosen from three essential TCM formulas, including Bai He Gu Jin Tang (yin nourishing), Wen Dan Tang (phlegm reducing), and Qing Shang Fang Fen Tang (heat clearing). The packages contained 1.6 g TCM preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of TCM preparations with each meal three times a day, for a total of nine packages per day. Administration of TCM was initiated at the same time as afatinib and continued for a total of three months. |
| Control arm | Placebo comparator | Drug: PlaceboPatients receive afatinib and placebo. Placebo without the medical ingredients was prepared to be similar to the weight, color, smell, taste, and packaging of the TCM formulas. The packages contained 1.6 g placebo preparations, which were manufactured in powder form by Sun Ten Pharmaceutical (Taichung, Taiwan) according to the good manufacturing practice requirements. Patients were instructed to intake three packages of placebo preparations with each meal three times a day, for a total of nine packages per day. Administration of placebo was initiated at the same time as afatinib and continued for a total of three months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically confirmed diagnosis of locally advanced or metastatic lung adenocarcinoma with EGFR mutations,
- Patients with an Eastern Cooperative Oncology Group performance status score of 0-2,
- Patients receiving afatinib as first-line treatment to ensure a shorter time to observe skin adverse effects of any grade,
- Patients with measurable disease evaluated by the Response Evaluation Criteria in Solid Tumors (version 1.1),
- Patients with brain metastases were included after adequate treatment.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TCM Formulathree packages of TCM preparations with each meal three times a day | Drug | Study arm |
| Placebothree packages of placebo preparations with each meal three times a day | Drug | Control arm |
Primary outcome
time to skin toxicity of any grade
Time frame: 3 month
Patients were instructed to maintain a diary to record the date on which skin toxicity of any grade first presented.
incidence of grade 3 skin toxicity
Time frame: 3 months
Patients were instructed to maintain a diary to record the date on which maximum EGFR-TKI-related skin toxicities occurred.
4 secondary outcomes
safety evaluation
Time frame: 3 months
quality of life evaluation
Time frame: 3 months
progression free survival
Time frame: 3 years
overall survival
Time frame: 3 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 24 Jan 2022.
- Background: PubMed 25908911Melosky B, Leighl NB, Rothenstein J, Sangha R, Stewart D, Papp K. Management of egfr tki-induced dermatologic adverse events. Curr Oncol. 2015 Apr;22(2):123-32. doi: 10.3747/co.22.2430.
- Background: PubMed 25704957Takeda M, Okamoto I, Nakagawa K. Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. Lung Cancer. 2015 Apr;88(1):74-9. doi: 10.1016/j.lungcan.2015.01.026. Epub 2015 Feb 7.
- Background: PubMed 26573073Melosky B, Anderson H, Burkes RL, Chu Q, Hao D, Ho V, Ho C, Lam W, Lee CW, Leighl NB, Murray N, Sun S, Winston R, Laskin JJ. Pan Canadian Rash Trial: A Randomized Phase III Trial Evaluating the Impact of a Prophylactic Skin Treatment Regimen on Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor-Induced Skin Toxicities in Patients With Metastatic Lung Cancer. J Clin Oncol. 2016 Mar 10;34(8):810-5. doi: 10.1200/JCO.2015.62.3918. Epub 2015 Nov 16.
- Background: PubMed 25453521Yang XB, Wu WY, Long SQ, Deng H, Pan ZQ. Effect of gefitinib plus Chinese herbal medicine (CHM) in patients with advanced non-small-cell lung cancer: a retrospective case-control study. Complement Ther Med. 2014 Dec;22(6):1010-8. doi: 10.1016/j.ctim.2014.10.001. Epub 2014 Oct 12.
- Background: PubMed 25074884Liu ZL, Zhu WR, Zhou WC, Ying HF, Zheng L, Guo YB, Chen JX, Shen XH. Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: a systematic review and meta-analysis. J Integr Med. 2014 Jul;12(4):346-58. doi: 10.1016/S2095-4964(14)60034-0.
- Derived from this study: PubMed 35297709Li CL, Hsia TC, Yang ST, Chao KC, Tu CY, Chen HJ, Li CH. Efficacy of Prophylactic Traditional Chinese Medicine on Skin Toxicity of Afatinib in EGFR Mutation-Positive Advanced Lung Adenocarcinoma: A Single-Center, Prospective, Double-Blinded, Randomized-Controlled Pilot Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221086663. doi: 10.1177/15347354221086663.
- Management of egfr tki-induced dermatologic adverse events.Link provided by the sponsor.
- Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancerLink provided by the sponsor.
- Pan Canadian Rash Trial: A Randomized Phase III Trial Evaluating the Impact of a Prophylactic Skin Treatment Regimen on Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor-Induced Skin Toxicities in Patients With Metastatic Lung CancerLink provided by the sponsor.
- Effect of gefitinib plus Chinese herbal medicine (CHM) in patients with advanced non-small-cell lung cancer: a retrospective case-control studyLink provided by the sponsor.
- Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: a systematic review and meta-analysisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Chia-Hsiang Li, Attending principal investigator
China Medical University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TCM Formula in people with Advanced Lung Adenocarcinoma, run by China Medical University 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 5 inclusion and 0 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 24 Jan 2022. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
time to skin toxicity of any grade (time frame: 3 month). 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?
On the ClinicalTrials.gov record for NCT05204758, which also lists 6 linked publications.
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 24 Jan 2022.