Squamous Non-small Cell Lung CancerPhase 3NCT04073537
Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
A Phase 3 study testing Anlotinib, Paclitaxel and Carboplatin in people with Squamous Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Non-small Cell Lung Cancer
- What is being tested?
- Anlotinib, Paclitaxel and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 386 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2019to 30 Jun 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous non-small cell lung cancer.
- A measurable lesion.
- The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
Who cannot join
- The tumor invades the large blood vessels.
- Central type squamous non-small cell lung cancer.
- EGFR/ALK gene mutation is positive.
- Has used EGFR inhibitors and ALK inhibitors.
- Has other malignant tumors within 5 years.
- Has a variety of factors affecting oral medications.
Show all 18Show fewer
- Symptomatic brain metastasis.
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- Spinal cord compression.
- Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
- Severe allergies to therapeutic medications.
- Adverse events caused by previous treatment did not recover to grade 1.
- Has received major surgical treatment within 4 weeks before randomization.
- Arteriovenous thrombosis occurred within 6 months.
- Has drug abuse history that unable to abstain from or mental disorders.
- Has severe or uncontrolled disease.
- Participated in other clinical trials within 4 weeks.
- According to the investigators' judgement.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100083
Yuankai Shi, Doctor, 010-87788293, syuankaipumc@126.com
Yuankai Shi
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011
Cuimin Ding, Master, 0311-86095341, wjwdcm@sina.com
Cuimin Ding, Master
About this study
Official title: A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
- Conditions
- Squamous Non-small Cell Lung Cancer
- Being tested
- Anlotinib, Placebos, Paclitaxel, Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
A multi-target receptor tyrosine kinase inhibitor.
PlacebosDrug
Anlotinib blank analog capsule.
PaclitaxelDrug
Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle.
CarboplatinDrug
Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Receives: Drug: Anlotinib; Drug: Paclitaxel; Drug: Carboplatin |
| Placebo group | Placebo comparator | Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. Receives: Drug: Placebos; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) evaluated by IRC
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
Measured: up to 24 months
Secondary outcomes (13)
Progression Free Survival (PFS) evaluated by investigator
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 24 months
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 24 months
Overall Response Rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 24 months
Disease Control Rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 24 months
Duration of Overall Response (DOR)
The time when the patient first achieved complete or partial remission to disease progression.
Measured: up to 24 months
PFS rate at month 6
The percentage of PFS at month 6.
Measured: up to 6 months
PFS rate at month 12
The percentage of PFS at month 12.
Measured: up to 12 months
OS rate at month 6
The percentage of OS at month 6.
Measured: up to 6 months
OS rate at month 12
The percentage of OS at month 12.
Measured: up to 12 months
OS rate at month 18
The percentage of OS at month 18.
Measured: up to 18 months
Adverse Event (AE)
Safety data
Measured: up to 24 months
Serious Adverse Event (SAE)
Safety data
Measured: up to 24 months
Abnormal laboratory test index
Safety data
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start31 Oct 2019 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073537
- Sponsor's protocol ID
- ALTN-03-III-02
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04073537
- Acronym / sponsor ID
- ALTN-03-III-02
- Conditions
- Squamous Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Aug 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.
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Anlotinib, Drug: Paclitaxel, Drug: CarboplatinAnlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. |
| Placebo group | Placebo comparator | Drug: Placebos, Drug: Paclitaxel, Drug: CarboplatinAnlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Squamous non-small cell lung cancer.
- A measurable lesion.
- The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- 5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
Key exclusion criteria (18 listed)
- The tumor invades the large blood vessels.
- Central type squamous non-small cell lung cancer.
- EGFR/ALK gene mutation is positive.
- Has used EGFR inhibitors and ALK inhibitors.
- Has other malignant tumors within 5 years.
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 |
|---|---|---|
| AnlotinibA multi-target receptor tyrosine kinase inhibitor. | Drug | Experimental group |
| PlacebosAnlotinib blank analog capsule. | Drug | Placebo group |
| PaclitaxelPaclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle. | Drug | Experimental group, Placebo group |
| CarboplatinCarboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle. | Drug | Experimental group, Placebo group |
Primary outcome
Progression Free Survival (PFS) evaluated by IRC
Time frame: up to 24 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
13 secondary outcomes
Progression Free Survival (PFS) evaluated by investigator
Time frame: up to 24 months
Overall Survival (OS)
Time frame: up to 24 months
Overall Response Rate (ORR)
Time frame: up to 24 months
Disease Control Rate（DCR）
Time frame: up to 24 months
Duration of Overall Response (DOR)
Time frame: up to 24 months
PFS rate at month 6
Time frame: up to 6 months
PFS rate at month 12
Time frame: up to 12 months
OS rate at month 6
Time frame: up to 6 months
OS rate at month 12
Time frame: up to 12 months
OS rate at month 18
Time frame: up to 18 months
Adverse Event (AE)
Time frame: up to 24 months
Serious Adverse Event (SAE)
Time frame: up to 24 months
Abnormal laboratory test index
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anlotinib, Paclitaxel and Carboplatin in people with Squamous Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 2 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 4 inclusion and 18 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi, Doctor (010-87788293, syuankaipumc@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) evaluated by IRC (time frame: up to 24 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 Aug 2019.