Multiple Primary Lung CancersPhase 2TERMGGONCT04982900
Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities
A Phase 2 study testing furmonertinib in people with Multiple Primary Lung Cancers, run by Ruijin Hospital at 6 sites in China.
Trial summary
This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Primary Lung Cancers
- What is being tested?
- furmonertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 6 sitesChina
- Study dates
- 1 Oct 2021to 1 Aug 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. The patient was diagnosed with MPLC (based on the previously published MM/ACCP clinical criteria). The preoperative chest CT scan (1mm slice thickness) found two or more ground glass lesions (≥6mm and <3 cm, pure ground glass or partial solid) that could not be operated at the same time;
- 2. The patient has received surgery to remove the main lesion. The pathology of the main lesion is NSCLC with sensitizing EGFR mutation positive (19del/L858R), with or without other EGFR mutations including T790M;
- 3. After resection of the main lesion, the patient should have at least one residual ground glass nodules (≥6mm and <3 cm) that are suspected of being malignant and cannot be resected simultaneously with main lesion. The malignancy has been confirmed by both qualified radiologist and thoracic surgeon;
- 4. The included MPLC patients' clinical staging from preoperative evaluation should be cTis-T1c, N0, M0 (according to NCCN/EEJC 2021 V1);
- 5. Patients' ECOG PS score 0-1;
- 6. The subject voluntarily participates in the study and has signed a written informed consent form.
Who cannot join
- 1. MPLC with lymph node metastasis, unresectable disease or distant metastasis, including pleural and pericardial metastasis;
- 2. Those who have severe cardiac, pulmonary, hepatic, and renal failure and cannot tolerate surgery;
- 3. Patients suffering from other malignant tumors or a history of other malignant tumors within 5 years; except effectively controlled skin basal cell carcinoma, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, superficial bladder tumor, etc.;
- 4. Patients requiring long-term use of strong CYP3A4 inhibitors or strong inducers within 7 days before the first administration or during the expected test period;
- 5. Patients who are receiving medications that are known to prolong the QTc interval or may cause torsade de pointes ventricular tachycardia, and who need to continue to receive these medications during the study period;
- 6. History of interstitial lung disease (ILD), or drug-induced interstitial lung disease;
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- 7. Severe gastrointestinal dysfunction, diseases or clinical conditions that may affect the intake, transport or absorption of the study drug, such as inability to take the drug orally, uncontrollable nausea and vomiting, history of extensive gastrointestinal resection, uncured recurrent diarrhea, atrophic gastritis (onset age less than 60 years old), uncured gastric diseases requiring proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, raneprazole, etc.) , Crohn's disease, ulcerative colitis, etc.;
- 8. Cardiovascular diseases which meet any of the following: (1) In the resting state, the QTc interval of ECG is >470 msec; (2) Severe abnormalities in heart rhythm, cardiac conduction, and resting ECG, such as complete left bundle branch block, third degree heart block, second degree heart block, PR interval> 250 msec, etc.; (3) Any factors that may increase the risk of QTc interval prolongation or the risk of arrhythmia events, such as heart failure, hypokalemia, hypomagnesemia, etc., congenital long QT syndrome, family history of long QT syndrome, Sudden death unexplained in first-degree relatives under 40 years of age or use of any drug combination that is known to prolong the QTc interval and cause torsion de pointes tachycardia; (4) Left ventricular ejection fraction (LVEF) <50%; (5) Having a history of myocardial infarction, severe or unstable angina, or coronary artery bypass surgery in the last 6 months, or cardiac insufficiency grade ≥ NYHA grade 2; (6) Uncontrollable hypertension (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
- 9. Active period of infectious diseases, such as hepatitis B, hepatitis C and human immunodeficiency virus (HIV) infections;
- 10. Women who are pregnant or breastfeeding, or have fertility but have not taken contraceptive measures;
- 11. People who suffer from uncontrollable neurological or mental illnesses or mental disorders, having poor compliance, cannot cooperate or describe treatment responses;
- 12. Participants in other clinical trials at the same time or expect to receive other anti-tumor treatments outside of this study during the trial period;
- 13. Other situations that researchers think are not suitable for participating in this research.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Chun Chen, Phd, MD, 00860591-83357896
- Not yet recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Ming Wu, Phd, MD, 00860571-87783777
- Not yet recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jian Hu, PhD, MD, 00860571-87236114
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Bentong Yu, PhD, MD, 00860791-88692748
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yajie Zhang, PhD, MD, +8613817163025, zhangyajieryan@163.com
Jiahao Zhang, MD, +8615821928973, zhangjiahao135@126.com
- Not yet recruiting
Tangdu Hospital
Xi'an, Shaanxi
Xiaolong Yan, 008602984777777
About this study
Official title: A Prospective, Multi-center, Double-blind Randomized Controlled Clinical Trial on the Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities
This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.
Read the detailed description
Lung cancer is one of the most deadly malignant tumors in the world. It is estimated that 0.2-20% of lung cancer patients have multiple primary lung cancers at the time of diagnosis, and many of them present with multiple ground glass opacities. The surgical method for such multiple lesions depends on their number, anatomical location and size, as well as the age and pulmonary function of the patient. It is easily affected by the subjective judgment of the surgeon. Besides, many of these patients develop multiple lesions that cannot be resected at the same time, and there haven't been established a standard therapy for residual GGO lesions after surgery.
According to the National Comprehensive Cancer Network (NCCN) guidelines, EGFR-TKI is recommended for the adjuvant treatment of stage IB-ⅢA NSCLC with EGFR mutations. However, it is not clear whether EGFR-TKI is effective for multiple primary lung cancers or the residual GGOs after surgical resection of the EGFR mutation positive main cancers. At present, there have been retrospective studies showing that application of EGFR-TKIs targeted therapy can significantly reduce the diameter of residual GGOs after surgery resection of EGFR mutation-positive primary lesions for MPLC patients, and reduce the secondary surgery caused by the progression of the lesion. However, there is no prospective Studies confirming the efficacy and safety of EGFR-TKI on these postoperative residual GGOs lesions.
This study is a multi-center, prospective, double-blind, comparative clinical research. This study plans to enroll 138 patients with multiple primary lung cancers (cTis-T1c, N0, M0) that manifest GGO and cannot be resected at the same time, patients should have undergone surgical resection of the EGFR mutated main lesion, and have no less than 1 GGO lesion remaining after surgery. Eligible patients will be randomly divided into the treatment group (receiving furmonertinib mesilate tablets) or control group (placebo) at a ratio of 1:1. The grouping process was strictly double-blind for both the investigators and subjects. By collecting the relevant data of patients' baseline images, pathology, and follow-up images during treatment, statistical analysis is used to evaluate the effectiveness (response rate, objective remission rate), safety, and relevant influencing factors (including CTR value of the main lesion, number of residual lesions, diameter of the largest residual lesion, higher stage of the main lesion, residual lesion's density, etc.) of EGFR-TKI treatment.
This study is expected to prove that compared with the placebo in the control group, EGFR-TKI can significantly reduce the diameter of residual GGO lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass density, and bring a higher objective response rate (ORR) but did not significantly increase the incidence of adverse effects.
- Conditions
- Multiple Primary Lung Cancers
- Being tested
- furmonertinib, Placebo
- Keywords
- Multiple Primary Lung Cancer, Ground-glass Opacity, EGFR-TKI, Targeted Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furmonertinibDrug
Also called AST2818
AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.
PlaceboDrug
The placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group.
| Study group | Role | What they receive |
|---|---|---|
| EGFR-TKI Treatment Arm | Experimental | After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of Furmonertinib on the day of baseline follow-up. Patients in the treatment group should take Furmonertinib (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of Furmonertinib for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs. Receives: Drug: furmonertinib |
| Control Arm | Placebo comparator | After randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of placebo on the day of baseline follow-up. Patients in the treatment group should take placebo (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of placebo for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of EGFR-TKI
defined in this study as the ratio of patients with reduced diameter of any residual lesions on CT scans to the entire patient cohort according to the Independent Review Committee (IRC) image evaluation follow-up.
Measured: 6 months
Secondary outcomes (5)
Lesion-oriented EGFR-TKI response rate
Defined as the ratio of lesions showing any reduction in diameter on the CT scan to the number of lesions in the entire cohort according to the Independent Review Committee (IRC) image evaluation during follow-up.
Measured: 6 months
Objective response rate (ORR)
ORR is evaluated after 6 months of treatment, defined according to the RECIST1.1 standard
Measured: 6 months
Response rate by Investigators' assessment
compared with the primary endpoint of Independent Review Committee (IRC) image evaluation
Measured: 6 months
Second operations
Number of subjects who had a second resection of residual lesions due to progress of lesions during follow-up.
Measured: 6 months
Treatment-related adverse events
the number and grades of treatment-related adverse events in each arm (grading according to CTCAE 5.0)
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 posted29 Jul 2021
- Study start1 Oct 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary Lung CancersStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Model description
- This study has two parallel arms, EGFR-TKI treatment arm and control arm (placebo) are included in this study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tang-Du Hospital, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng Li, PhD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982900
- Sponsor's protocol ID
- RTS-015
- Acronym
- TERMGGO
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Double-blind Randomized Controlled Clinical Trial on the Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities
- ClinicalTrials.gov ID
- NCT04982900
- Acronym / sponsor ID
- TERMGGO / RTS-015
- Conditions
- Multiple Primary Lung Cancers
- Keywords
- Multiple Primary Lung Cancer, Ground-glass Opacity, EGFR-TKI, Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tang-Du Hospital, The First Affiliated Hospital of Nanchang University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 29 Jul 2021 (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.
This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.
Detailed description
Lung cancer is one of the most deadly malignant tumors in the world. It is estimated that 0.2-20% of lung cancer patients have multiple primary lung cancers at the time of diagnosis, and many of them present with multiple ground glass opacities. The surgical method for such multiple lesions depends on their number, anatomical location and size, as well as the age and pulmonary function of the patient. It is easily affected by the subjective judgment of the surgeon. Besides, many of these patients develop multiple lesions that cannot be resected at the same time, and there haven't been established a standard therapy for residual GGO lesions after surgery.
According to the National Comprehensive Cancer Network (NCCN) guidelines, EGFR-TKI is recommended for the adjuvant treatment of stage IB-ⅢA NSCLC with EGFR mutations. However, it is not clear whether EGFR-TKI is effective for multiple primary lung cancers or the residual GGOs after surgical resection of the EGFR mutation positive main cancers. At present, there have been retrospective studies showing that application of EGFR-TKIs targeted therapy can significantly reduce the diameter of residual GGOs after surgery resection of EGFR mutation-positive primary lesions for MPLC patients, and reduce the secondary surgery caused by the progression of the lesion. However, there is no prospective Studies confirming the efficacy and safety of EGFR-TKI on these postoperative residual GGOs lesions.
This study is a multi-center, prospective, double-blind, comparative clinical research. This study plans to enroll 138 patients with multiple primary lung cancers (cTis-T1c, N0, M0) that manifest GGO and cannot be resected at the same time, patients should have undergone surgical resection of the EGFR mutated main lesion, and have no less than 1 GGO lesion remaining after surgery. Eligible patients will be randomly divided into the treatment group (receiving furmonertinib mesilate tablets) or control group (placebo) at a ratio of 1:1. The grouping process was strictly double-blind for both the investigators and subjects. By collecting the relevant data of patients' baseline images, pathology, and follow-up images during treatment, statistical analysis is used to evaluate the effectiveness (response rate, objective remission rate), safety, and relevant influencing factors (including CTR value of the main lesion, number of residual lesions, diameter of the largest residual lesion, higher stage of the main lesion, residual lesion's density, etc.) of EGFR-TKI treatment.
This study is expected to prove that compared with the placebo in the control group, EGFR-TKI can significantly reduce the diameter of residual GGO lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass density, and bring a higher objective response rate (ORR) but did not significantly increase the incidence of adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study has two parallel arms, EGFR-TKI treatment arm and control arm (placebo) are included in this study.
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKI Treatment Arm | Experimental | Drug: furmonertinibAfter randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of Furmonertinib on the day of baseline follow-up. Patients in the treatment group should take Furmonertinib (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of Furmonertinib for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs. |
| Control Arm | Placebo comparator | Drug: PlaceboAfter randomization, the enrolled patients in this arm should be completely free from the risk of perioperative complications or recovered from the effects of complications, usually no earlier than 4 weeks after surgery but no more than 10 weeks after surgery, before receiving baseline follow-up and starting oral administration of placebo on the day of baseline follow-up. Patients in the treatment group should take placebo (80 mg each time) orally on an empty stomach before breakfast once a day. The medicine should be taken about the same time each day, by swallowing the whole tablet with water, without crushing or chewing. Patients should maintain oral administration of placebo for 6 consecutive months, unless there is disease progression, death, new anti-tumor therapy received or intolerance of investigational drugs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. The patient was diagnosed with MPLC (based on the previously published MM/ACCP clinical criteria). The preoperative chest CT scan (1mm slice thickness) found two or more ground glass lesions (≥6mm and <3 cm, pure ground glass or partial solid) that could not be operated at the same time;
- 2. The patient has received surgery to remove the main lesion. The pathology of the main lesion is NSCLC with sensitizing EGFR mutation positive (19del/L858R), with or without other EGFR mutations including T790M;
- 3. After resection of the main lesion, the patient should have at least one residual ground glass nodules (≥6mm and <3 cm) that are suspected of being malignant and cannot be resected simultaneously with main lesion. The malignancy has been confirmed by both qualified radiologist and thoracic surgeon;
- 4. The included MPLC patients' clinical staging from preoperative evaluation should be cTis-T1c, N0, M0 (according to NCCN/EEJC 2021 V1);
- 5. Patients' ECOG PS score 0-1;
Key exclusion criteria (13 listed)
- 1. MPLC with lymph node metastasis, unresectable disease or distant metastasis, including pleural and pericardial metastasis;
- 2. Those who have severe cardiac, pulmonary, hepatic, and renal failure and cannot tolerate surgery;
- 3. Patients suffering from other malignant tumors or a history of other malignant tumors within 5 years; except effectively controlled skin basal cell carcinoma, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, superficial bladder tumor, etc.;
- 4. Patients requiring long-term use of strong CYP3A4 inhibitors or strong inducers within 7 days before the first administration or during the expected test period;
- 5. Patients who are receiving medications that are known to prolong the QTc interval or may cause torsade de pointes ventricular tachycardia, and who need to continue to receive these medications during the study period;
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 |
|---|---|---|
| furmonertinibAlso: AST2818AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC. | Drug | EGFR-TKI Treatment Arm |
| PlaceboThe placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group. | Drug | Control Arm |
Primary outcome
Response rate of EGFR-TKI
Time frame: 6 months
defined in this study as the ratio of patients with reduced diameter of any residual lesions on CT scans to the entire patient cohort according to the Independent Review Committee (IRC) image evaluation follow-up.
5 secondary outcomes
Lesion-oriented EGFR-TKI response rate
Time frame: 6 months
Objective response rate (ORR)
Time frame: 6 months
Response rate by Investigators' assessment
Time frame: 6 months
Second operations
Time frame: 6 months
Treatment-related adverse events
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 5 Oct 2021.
- 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.
Hecheng Li, PhD, MD principal investigator
Ruijin Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing furmonertinib in people with Multiple Primary Lung Cancers, run by Ruijin Hospital at 6 sites 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 13 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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 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 Hecheng Li, PhD, MD (+8613917113402, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of EGFR-TKI (time frame: 6 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 5 Oct 2021.