Stage III Non-small-cell Lung CancerPhase 2NCT04181372
A Study of Neoadjuvant Chemotherapy Plus Anlotinib in Stage III(N2) Non-small-cell Lung Cancer
A Phase 2 study testing Anlotinib hydrochloride and platinum-based chemotherapy medicine in people with Stage III Non-small-cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage III Non-small-cell Lung Cancer
- What is being tested?
- Anlotinib hydrochloride and platinum-based chemotherapy medicine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2019to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age :18 Years to 75 Years (Adult, Older Adult)
- Pathological diagnosis with Stage III-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
- EGFR、ALK、ROS1 mutation-negative；Patients with squamous cell carcinoma may not have genetic testing;PD-L1<5%;
- According to the RECIST 1.1 standard, there is at least one measurable target lesion;
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
- The main organ function meets the following criteria:1)blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;2)Blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
- Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.
Who cannot join
- Stage I, II , IV orNSCLC;
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);central lung squamous carcinoma along with cavum;
- Patients with contraindication of chemotherapy
- Subjects who have previously used Anlotinib;
- Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
- Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
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- A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
- A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
- Cardiac diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia with difficult drug control (including clinically significant QTc interval prolongation history, or screening period QTc interval women >470ms, Male > 450ms), had myocardial infarction within 6 months, or cardiac insufficiency;
- Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
- Surgery (<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;
- Active or uncontrolled serious infections;
- Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;
- Increasing the risk associated with participating in a study or study drug, and at the discretion of the investigator, may lead to other conditions in which the patient is not eligible for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 457
Jiexia Zhang, +8613903056432, drzjxcn@126.com
About this study
Official title: A Phase II Study of Neoadjuvant Double-drug Chemotherapy With Platinum Plus Anlotinib Hydrochloride in Stage III(N2) Non-small-cell Lung Cancer
Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant double-drug chemotherapy containing platinum plus anlotinib hydrochloride in patients with stage III(N2) non-small-cell lung cancer.
Read the detailed description
This is a prospective, open-label, multi-institutional, positive medicine control of equal rank comparative study of neoadjuvant double-drug chemotherapy with platinum plus anlotinib hydrochloride in stage III(N2) non-small-cell lung cancer.The main purpose of this study was to compare the difference in N2 downgrade rate of lymph node and resectability rate between the experimental and control groups, to evaluate the efficacy of anlotinib hydrochloride, and to observe and evaluate its objective response rate(ORR)，Disease-free Survival (DFS)and overall survival(OS).
- Conditions
- Stage III Non-small-cell Lung Cancer
- Being tested
- Anlotinib hydrochloride, platinum-based chemotherapy medicine
- Keywords
- Stage III Non-small-cell Lung Cancer, Anlotinib Hydrochloride, Neoadjuvant
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
Also called AL3818
Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles.
platinum-based chemotherapy medicineDrug
(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib plus Platinum-based chemotherapy | Experimental | 1. Take anlotinib hydrochloride 12mg once daily for two weeks, stop for one week, the program repeats every 21 days for 2 cycles.
2. Platinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. Receives: Drug: Anlotinib hydrochloride |
| platinum-based chemotherapy | Active comparator | Platinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. Receives: Drug: platinum-based chemotherapy medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node(N2)downstage rate
Lymph node downstage rate is depended on the image or pathology dignosis after surgery,staging from N2 to N1 / N0.
Measured: 3 months
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Measured: 3 months
Resectability rate
Resectability rate was defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Measured: Lymph node downstage rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from randomization.
Pathological complete response (pCR) rate
Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery.
Measured: 3 months
Disease-free Survival （DFS）
The period after curative treatment [disease eliminated] when no disease can be detected.From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months.
Measured: Every 3 months.
Overall Survival (OS)
OS was assessed from randomization to death as a result of any cause.
Measured: 3 years
adverse events(AEs)
Number of participants with perioperative complications.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study startDec 2019 (estimated)
- Primary completion1 Aug 2021 (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 Stage III Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexia Zhang, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jiexia Zhang, prof., Study chair, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181372
- Sponsor's protocol ID
- NSCLC 001
- Status last verified
- Nov 2019
- First submitted
- 17 Apr 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Double-drug Chemotherapy With Platinum Plus Anlotinib Hydrochloride in Stage III(N2) Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04181372
- Acronym / sponsor ID
- NSCLC 001
- Conditions
- Stage III Non-small-cell Lung Cancer
- Keywords
- Stage III Non-small-cell Lung Cancer, Anlotinib Hydrochloride, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 29 Nov 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.
Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant double-drug chemotherapy containing platinum plus anlotinib hydrochloride in patients with stage III(N2) non-small-cell lung cancer.
Detailed description
This is a prospective, open-label, multi-institutional, positive medicine control of equal rank comparative study of neoadjuvant double-drug chemotherapy with platinum plus anlotinib hydrochloride in stage III(N2) non-small-cell lung cancer.The main purpose of this study was to compare the difference in N2 downgrade rate of lymph node and resectability rate between the experimental and control groups, to evaluate the efficacy of anlotinib hydrochloride, and to observe and evaluate its objective response rate(ORR)，Disease-free Survival (DFS)and overall survival(OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib plus Platinum-based chemotherapy | Experimental | Drug: Anlotinib hydrochloride1. Take anlotinib hydrochloride 12mg once daily for two weeks, stop for one week, the program repeats every 21 days for 2 cycles. 2. Platinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. |
| platinum-based chemotherapy | Active comparator | Drug: platinum-based chemotherapy medicinePlatinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age :18 Years to 75 Years (Adult, Older Adult)
- Pathological diagnosis with Stage III-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
- EGFR、ALK、ROS1 mutation-negative；Patients with squamous cell carcinoma may not have genetic testing;PD-L1<5%;
- According to the RECIST 1.1 standard, there is at least one measurable target lesion;
- ECOG physical score 0-1 points; expected survival time ≥ 3 months;
Key exclusion criteria (15 listed)
- Stage I, II , IV orNSCLC;
- Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);central lung squamous carcinoma along with cavum;
- Patients with contraindication of chemotherapy
- Subjects who have previously used Anlotinib;
- Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
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 |
|---|---|---|
| Anlotinib hydrochlorideAlso: AL3818Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles. | Drug | Anlotinib plus Platinum-based chemotherapy |
| platinum-based chemotherapy medicine(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles. | Drug | platinum-based chemotherapy |
Primary outcome
Lymph node(N2)downstage rate
Time frame: 3 months
Lymph node downstage rate is depended on the image or pathology dignosis after surgery,staging from N2 to N1 / N0.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: 3 months
Resectability rate
Time frame: Lymph node downstage rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from randomization.
Pathological complete response (pCR) rate
Time frame: 3 months
Disease-free Survival （DFS）
Time frame: Every 3 months.
Overall Survival (OS)
Time frame: 3 years
adverse events(AEs)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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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.
Jiexia Zhang, prof. study chair
The First Affiliated Hospital of Guangzhou Medical University
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 Anlotinib hydrochloride and platinum-based chemotherapy medicine in people with Stage III Non-small-cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. 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 Jiexia Zhang, prof. (+8613903056432, drzjxcn@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node(N2)downstage rate (time frame: 3 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 29 Nov 2019.