NSCLCPhase 4NCT03986528
Clinical Trial of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
A Phase 4 study testing Kanglaite Injection+Chemotherapy and Chemotherapy in people with NSCLC, run by Jie Li at 17 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Kanglaite Injection+Chemotherapy and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 17 sitesChina
- Study dates
- 28 Aug 2019to 31 May 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
- Male or female aged 18-75years;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
- Life expectancy of at least 3 months;
- At least one radiographically measurable lesion per RECIST 1.1;
- Willing to join the clinic trail and sign informed consent;
- Able to comply with scheduled visits and treatments.
Who cannot join
- Presence of cerebral metastases;
- Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score [TPS≥ 50%] in a genetic test;
- Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
- Current undergoing or preparing for treatment with target therapy;
- Current undergoing or preparing for radiotherapy to the thorax;
- Current undergoing or preparing treatment with tumor immunotherapy;
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- Currently undergoing lipid-decreasing treament;
- Pregnant or breastfeeding woman;
- Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;
- A history of mental disorders；
- Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;
- Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment;
- Known allergy or intolerance to study medications;
- Considered to be otherwise unsuitable for the clinical study by researchers.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Recruiting
Hunan Academy of Traditional Chinese Medicine Affiliated Hospital
Changsha, Hunan, 410013
Yan Lou
- Recruiting
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013
Hong Wu
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fangfei Li
- Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guanzhou, Guangdong, 510405
Hanrui Chen
- Recruiting
The First Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, 310006
Hong Pan
- Recruiting
Anhui Chest Hospital
Hefei, Anhui, 230022
Mei Chai, MM
- Recruiting
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250014
Jiehui Li
- Recruiting
Gansu Provincial Tumor Hospital
Lanzhou, Gansu, 730050
Xudong Lei
- Recruiting
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029
Li Zhang
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Lihua Zhu
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437
Ling Xu, MD
- Recruiting
The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 110032
Hong Gao
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Yong Zhang
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Zhansheng Jiang
- Recruiting
The Fourth Military Medical University Tangdu Hospital
Xian, Shanxi, 710038
Canjun Zhao
- Recruiting
XuZhou Central Hospital
Xuzhou, Jiangsu, 221009
Yong Liu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Xu Sun
About this study
Official title: Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
Read the detailed description
This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
- Conditions
- NSCLC
- Being tested
- Kanglaite Injection+Chemotherapy, Chemotherapy
- Keywords
- Advanced Non-Small Cell Lung Cancer, Kanglaite Injection, Chinese Herbal Medicine, Randomized Controlled Trial, Progression-free Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kanglaite Injection+ChemotherapyDrug
Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.
ChemotherapyDrug
Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Kanglaite Injection + Chemotherapy | Experimental | Participants receive Kanglaite Injection PLUS first-line chemotherapy. Receives: Drug: Kanglaite Injection+Chemotherapy |
| Chemotherapy | Active comparator | first-line chemotherapy. Receives: Drug: Chemotherapy |
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), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Measured: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had a Complete Response (CR:Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1.
Measured: Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
One-Year Survival Rate
One-year survival rate refers to the proportion of patients with a survival period of more than one year starting from randomized enrollment.
Measured: Randomization until One year.
Quality of life of the patient
This will be measured with validated questionnaires (EORTC-QLQ C30) and Lung Cancer Symptom Scale(LCSS).
Measured: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Living ability of the patient
This will be measured with validated questionnaires(ECOG) and Karnofsky performance status (KPS).
Measured: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Blood lipid
total cholesterol, triacylglycerides, high density cholesterol, low density cholesterol.
Measured: every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
Percentage of Participants With Adverse Events
Percentage of Participants With Adverse Events in different arms.
Measured: Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start28 Aug 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 May 2022 (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 NSCLCStudies of the same condition, open and under way.
- 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
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor-investigator, Jie Li, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986528
- Sponsor's protocol ID
- 2018YFC1707405
- Status last verified
- Feb 2021
- First submitted
- 30 May 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of the study will be issued to publications through scientific journals and conference reports. The anonymized datasets used and/or analyzed during the current study are available from the sponsor-investigator on reasonable request.
Publications
Gao R, Zhang Y, Hou W, Li J, Zhu G, Zhang X, Xu B, Wu Z, Wang H. Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial. Trials. 2021 Mar 17;22(1):214. doi: 10.1186/s13063-021-05169-w.
PubMed 33731199
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03986528
- Acronym / sponsor ID
- 2018YFC1707405
- Conditions
- NSCLC
- Keywords
- Advanced Non-Small Cell Lung Cancer, Kanglaite Injection, Chinese Herbal Medicine, Randomized Controlled Trial, Progression-free Survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 14 Jun 2019 (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 purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
Detailed description
This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kanglaite Injection + Chemotherapy | Experimental | Drug: Kanglaite Injection+ChemotherapyParticipants receive Kanglaite Injection PLUS first-line chemotherapy. |
| Chemotherapy | Active comparator | Drug: Chemotherapyfirst-line chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
- Male or female aged 18-75years;
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
- Life expectancy of at least 3 months;
- At least one radiographically measurable lesion per RECIST 1.1;
Key exclusion criteria (14 listed)
- Presence of cerebral metastases;
- Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score [TPS≥ 50%] in a genetic test;
- Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
- Current undergoing or preparing for treatment with target therapy;
- Current undergoing or preparing for radiotherapy to the thorax;
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 |
|---|---|---|
| Kanglaite Injection+ChemotherapyPatients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy. | Drug | Kanglaite Injection + Chemotherapy |
| ChemotherapyPatients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. | Drug | Chemotherapy |
Primary outcome
Progression Free Survival(PFS)
Time frame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
One-Year Survival Rate
Time frame: Randomization until One year.
Quality of life of the patient
Time frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Living ability of the patient
Time frame: before and after each cycle of treatment, assessed up to 12 months after randomized enrollment
Blood lipid
Time frame: every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.
Percentage of Participants With Adverse Events
Time frame: Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 33731199Gao R, Zhang Y, Hou W, Li J, Zhu G, Zhang X, Xu B, Wu Z, Wang H. Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial. Trials. 2021 Mar 17;22(1):214. doi: 10.1186/s13063-021-05169-w.
- Individual participant dataSharing planned: Yes. The results of the study will be issued to publications through scientific journals and conference reports. The anonymized datasets used and/or analyzed during the current study are available from the sponsor-investigator on reasonable request.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kanglaite Injection+Chemotherapy and Chemotherapy in people with NSCLC, run by Jie Li at 17 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 7 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 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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 Gao rui ke (+86 1088001192, gaork2015@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival(PFS) (time frame: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.). 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 NCT03986528, 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 23 Feb 2021.